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Improving Community Ambulation After Hip Fracture (CAP)

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ClinicalTrials.gov Identifier: NCT01783704
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Arcadia University
UConn Health
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Jay S. Magaziner, University of Maryland

Brief Summary:

Activity and exercise are believed to be of benefit for reducing disability in older adults, yet the majority of older adults do not participate in regular exercise and is not active. This is especially true for older adults following hip fracture after they complete the usual rehabilitation program.

This study is being done to compare two 16-week supervised multi-part physical therapy programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want to test whether the interventions lead to improvements in a person's ability to walk on their own in the home and in the local community. With this knowledge the investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health.

ANCILLARY STUDY #1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION (CAP-MP) The goal of this ancillary study is to investigate several mechanisms thought to be related to recovery in ambulatory ability after hip fracture. Selected mechanistic pathways are being investigated by obtaining mechanistic measurements of the participants randomized in the University of Maryland, Baltimore (UMB) clinical site of CAP.

ANCILLARY STUDY #2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION The goal of this ancillary study is to analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture. The identified dietary patterns, as well as motivators and barriers to intake, will be assessed for their impact on the rate of return to community ambulation in participants randomized at the University of Connecticut Health Center (UCHC) clinical site of CAP.

ANCILLARY STUDY #3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in participants randomized at the UCHC clinical site of CAP.

ANCILLARY STUDY #4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE The goal of this ancillary study is to understand some of the key muscle mechanisms associated with recovery in community ambulation following hip fracture in response to the two interventions for participants randomized at the Arcadia University (AU) clinical site of CAP.


Condition or disease Intervention/treatment Phase
Hip Fracture Dietary Supplement: Nutrition Behavioral: PUSH Behavioral: PULSE Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

Study PI (Magaziner) and Co-PI (Craik) and members of the Clinical Coordinating Center (Orwig, Lewis) are blinded to treatment assignment.

Clinical site PIs and clinical site coordinators who are responsible for assigning work and/or assessing for treatment fidelity of PTs in both groups are unblinded.

Staff who perform evaluations (clinical site visits and telephone interviews) after randomization and the Independent Safety Monitor (ISM) who will be blinded to treatment assignment.

The PTs only know specific information about the intervention he/she is delivering. To minimize "contamination" of the interventions, each PT provides only one of the interventions and PTs do not have contact with participants in the other group or with PTs providing the intervention to the other group. As PTs are hired for the study, they are assigned at random to one of the interventions.

Primary Purpose: Supportive Care
Official Title: Improving Community Ambulation After Hip Fracture
Actual Study Start Date : June 10, 2013
Actual Primary Completion Date : October 17, 2017
Actual Study Completion Date : October 17, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PUSH and Nutrition
PUSH is a specific multi-component intervention based on improving specific precursors to community ambulation. The intervention addresses endurance with continuous upright exercise for 20 min.; function by improving fast walking, standing from a chair, and stair negotiation; muscle performance by exercising to enhance lower extremity strength; and balance by performing unilateral activities and activities with decreased base of support. Participants receive 32 visits of approximately 60 minutes in duration from a study PT. Participants will receive up to three visits a week, on non-consecutive days, for 16 weeks. Visits take place in the participant's place of residence. Participants also receive the nutritional intervention for the duration of the 16-week study.
Dietary Supplement: Nutrition
Participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the study. Nutritional counseling is also provided. Participants are screened at time of randomization to assess nutritional risk using the Mini Nutritional Assessment-Short Form and contacted by a registered dietician (RD) within 7 days of randomization. Those who score ≤7 (malnourished) and participants with baseline serum albumin 2.5-3.5 g/dl receive a visit from an RD with follow-up a week later. Participants who score 8-11 (at risk of malnutrition) and have serum albumin level >3.5 g/dl receive a phone call from the RD and may receive an in-person visit if warranted. Those screening in the normal range (12-14) and have serum albumin level >3.5 g/dl receive a phone call from the RD. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the RD. Those who lose 5% or more body weight between baseline and follow-up may be referred to an RD.
Behavioral: PUSH
Strength components of the muscle performance intervention are performed using a portable progressive resistive exercise device (Shuttle® MiniPress, Contemporary Design Company, P.O. Box 5089, Glacier, Washington 98244). Muscle performance focuses on bilateral hip extensors, hip abductors, knee extensors, and plantar flexors. Balance and strength are addressed with additional exercises performed while standing. The endurance intervention begins with 2-3 minutes of continuous upper and lower extremity active range of motion (AROM) with the participant sitting in order to increase the participants' heart rate (HR) or exertion closer to the target zone. The participant is then asked to walk on level surfaces and/or up and down steps to keep the HR within the training zone for 20 minutes.
Experimental: PULSE and Nutrition
PULSE is a non-specific multi-component intervention in which participants will receive flexibility exercises, active range of motion (AROM) for the upper and lower extremities, breathing exercises, and transcutaneous electrical nerve stimulation (TENS). Participants receive 32 visits of approximately 60 minutes in duration from a study PT. Participants will receive up to three visits a week, on non-consecutive days, for 16 weeks. Visits will take place in the participant's place of residence. Participants will also receive the nutritional intervention for the duration of the 16-week study.
Dietary Supplement: Nutrition
Participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the study. Nutritional counseling is also provided. Participants are screened at time of randomization to assess nutritional risk using the Mini Nutritional Assessment-Short Form and contacted by a registered dietician (RD) within 7 days of randomization. Those who score ≤7 (malnourished) and participants with baseline serum albumin 2.5-3.5 g/dl receive a visit from an RD with follow-up a week later. Participants who score 8-11 (at risk of malnutrition) and have serum albumin level >3.5 g/dl receive a phone call from the RD and may receive an in-person visit if warranted. Those screening in the normal range (12-14) and have serum albumin level >3.5 g/dl receive a phone call from the RD. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the RD. Those who lose 5% or more body weight between baseline and follow-up may be referred to an RD.
Behavioral: PULSE
During the AROM exercises, participants work to increase flexibility and range of motion. Exercises include the neck, shoulders, arms, trunk, hips, knees and ankles. During all AROM exercises, the participant focuses on deep breathing techniques. The second part of the session uses transcutaneous electrical nerve stimulation (TENS) on lower extremity muscle groups to decrease pain, thereby allowing greater ease of mobility. TENS uses low-level electrical current to stimulate superficial cutaneous nerve fibers through the skin. Flexible carbonized, disposable electrodes coated with a self-adhesive conductive polymer will be applied to the skin bilaterally near the motor points on muscle bellies (the gluteal complex, the quadriceps, and the gastrocnemius) for 7 minutes per muscle group.



Primary Outcome Measures :
  1. Ability to walk 300 meters or more in six minutes [ Time Frame: 16 weeks post-randomization ]
    The primary study outcome reflects the concept of a minimum distance a person needs to be able to walk to carry out usual activities in the community. This will be defined as achieving the threshold value of 300 meters or more on the Six-Minute Walk Test (SMWT). The SMWT is an assessment with excellent psychometric properties, and there is sound justification for a 300 m distance threshold on the SMWT (equivalent to walking at 0.8 m/s) to serve as an indicator for community ambulatory ability.


Secondary Outcome Measures :
  1. Ability to walk 300 meters or more in six minutes [ Time Frame: 40 weeks post-randomization ]
    Performance of the SMWT (described above) will be used to determine whether the proportion of community ambulators differs between the PUSH and PULSE interventions at 40 weeks post-randomization and whether the difference in proportions at 40 weeks changed from the difference in proportions at 16 weeks.

  2. Endurance [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    To assess endurance, the SMWT (described above) will be used to obtain a continuous measure of total distance walked in six minutes. The SMWT is highly correlated with workloads, heart rate, oxygen saturation, and dyspnea responses when compared to bicycle ergometry and treadmill exercise tests in older persons. It has been performed by elderly, frail and severely compromised participants who cannot perform standard maximal treadmill or cycle ergometry exercise tests.

  3. Balance [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    We will use an enhanced balance measure that includes the balance subscale of the Short Physical Performance Battery (SPPB) and two additional single leg stands (eyes open and eyes closed), as used in the National Health and Aging Trends Study (NHATS). For the test of standing balance, participants are asked to maintain balance in three positions, characterized by a progressive narrowing of the base support (side-by-side, semi-tandem, and tandem). For each of the three positions, participants are timed to a maximum of 10 seconds. Participants are then asked to stand on one leg (on the side of the fracture) with eyes open and again with eyes closed. Each of the single leg stands are held for up to 30 seconds. The number of seconds is then summed across the 5 items to obtain the measure of balance. These tests are hierarchical such that when a participant fails an item, the harder ones are not administered and receive a score of 0.

  4. Quadriceps muscle strength [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]

    Isometric force for bilateral knee extensors will be measured with a portable, hand-held dynamometer (Microfet2 Manual Muscle Tester). Participants will be seated on the strength testing chair to increase stabilization, with hip flexion 90° and knee flexed to 70°, stabilization straps on the pelvis and thigh, and resistance applied just proximal to the ankle on the anterior surface of the leg. Participants will be asked to push as hard and as fast as possible for five seconds. Three maximal effort trials, with a one-minute rest between trials, will be performed. The reported test-retest reliability with hand-held dynamometry is excellent (r>.90) if tested in one session and in subjects with muscle weakness (intraclass correlation coefficient ≥ .90). The peak force will be recorded for each of the three trials and the highest value will be used.

    This measure will not be collected for participants consented under protocol version 11.0 or later.


  5. Lower extremity function [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    A modified version of the Physical Performance Test (mPPT) will be used to measure lower extremity function at baseline and follow-up. The modification, used by Binder et al., substitutes a chair-rise task and a balance task for writing and eating tasks, in order to emphasize lower extremity function. The modified PPT includes nine standardized tasks that will be timed (e.g., picking up a penny from the floor, standing up five times from a 16-inch chair). The tasks are performed twice and the times from the two trials are averaged. The score for each item ranges from 0 to 4, with 36 representing a perfect score. Test-retest reliability for the modified PPT score is 0.96. Because there is some overlap between the mPPT and SPPB items, we have integrated the two scales so that participant burden is minimized but it is still possible to obtain scores on each of the scales.

  6. Fast walking speed [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    Within the mPPT, participants are asked to walk a distance of 50 feet walking quickly but safely. The time required to walk 50 ft will be the measure of fast walking speed.

  7. Cost effectiveness: health care utilization [ Time Frame: Every four weeks, up to 16 weeks post-randomization and up to 40 weeks post-randomization for a subset of participants ]

    The economic value of the interventions will be determined by assessing the impact on quality-adjusted life years (QALYs), cost, and cost per QALY gained over the 16 weeks following randomization. The cost-effectiveness analyses will address both the within trial comparison of the study interventions and a model-based comparison of the study interventions and usual care.

    This measure will not be collected for participants consented under protocol version 11.0 or later.


  8. Short Physical Performance Battery (SPPB) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    The SPPB evaluates lower extremity performance in older persons based on timed short distance walk, repeated chair stands, and a set of balance tests. Each of the tasks is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 an inability to complete the test. The test takes about 10-15 minutes to administer and was designed to be administered by a lay interviewer in a setting with limited space. The battery has an excellent safety record. It has been administered to well over 10,000 persons in various studies and no serious injuries are known to have occurred. The SPPB components and total score are derived from normative values obtained from a population-based study.


Other Outcome Measures:
  1. Activities of daily living (ADLs) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]

    We will measure ADLs using the Pepper Assessment Tool for Disability (PAT-D) with two modifications. First, two items (walking a quarter mile and walking across a small room) were added to address perceived gaps in the original PAT-D scale. This modification is consistent with the version used in the Lifestyle Interventions and Independence for Elders study. Second, two items (walking several blocks and lifting heavy objects) were deleted to avoid duplication with other items in the scale. The resulting 19-item scale allows examination of three subscales (basic ADL, functional limitations, and instrumental ADL).

    This measure will not be collected for participants consented under protocol version 11.0 or later.


  2. Quality of life (SF-36) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]

    We will use an interviewer-administered version of the SF-36, a health survey that assesses quality of life in eight subscales (physical function, social function, role-physical, role-emotional, bodily pain, mental health, general health, and vitality). The measure has been validated as a generic measure of quality of life in many different populations, including patient and non-patient samples.

    This measure will not be collected for participants consented under protocol version 11.0 or later.


  3. Balance confidence [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]

    The Activities-specific Balance Confidence (ABC) scale is a 16-item measure that asks respondents to rate their confidence in maintaining their balance while doing daily activities. Test-retest reliability, internal consistency, and concurrent validity with fall and physical activity are high. This measure has been used successfully in hip fracture patients.

    This measure will not be collected for participants consented under protocol version 11.0 or later.


  4. Yale Physical Activity Survey (YPAS) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]

    This interviewer-administered questionnaire includes five categories of common activities related to work, exercise, and recreation performed during a typical week in the past month. The YPAS increases the sensitivity of other physical activity surveys by describing a wider range of lower intensity activities that older adults often engage in. Participation in each activity (hrs/week) will be multiplied by an intensity code (kcal/min) and then summed over all activities to calculate a weekly energy expenditure summary. The measure has been validated against several physiological variables of habitual activity. The YPAS has been used to estimate change in older adults in an exercise intervention program.

    This measure will not be collected for participants consented under protocol version 11.0 or later.


  5. Improvement in walking [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    Whether or not there was an increase of at least 50 meters in the distance walked on the SMWT will be assessed as a tertiary outcome. This distance has been shown to be clinically meaningful.

  6. Depressive symptoms [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    Depressive symptoms will be measured using the 20-item Center for Epidemiologic Studies Depression (CES-D) scale, which asks about depressive symptoms experienced in the previous week. There is evidence that recovery post-fracture is delayed in the presence of depression. This scale ranges from 0-60 with higher scores indicating greater depression.

  7. Cognitive status [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]

    Cognitive status will be assessed at follow-up using the 3MS.

    This measure will not be collected for participants consented under protocol version 11.0 or later.


  8. Nutritional status [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]

    Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA®-SF), a validated and widely used malnutrition screening tool. We are using a modified version of the MNA®, approved by the scale's developer (the Nestlé company), to facilitate use as an interviewer-administered tool in a research setting. Scores range from 0 to 14; participants scoring ≤7 will be considered malnourished; those scoring 8-11 will be considered to be at risk of malnutrition; and those scoring 12-14 will be considered to have normal nutritional status.

    This measure will not be collected at follow-up for participants consented under protocol version 12.0 or later.


  9. Ancillary Study #1 - Muscle and fat mass [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    Muscle and lean mass will be estimated using dual-energy x-ray absorptiometry (DXA) (GE LUNAR, Madison, WI). DXA calculates fat mass (g) and muscle mass (g) from the total body scan and values are provided in the report produced by the DXA machine. The coefficient of variation of these measurements in our previous studies for fat and lean mass was 1.4% and 1.3%, respectively.

  10. Ancillary Study #1 - Muscle composition: Intramuscular fat and muscle volume [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    Intramuscular fat and muscle volume are calculated when analyzing the thigh CT scan. Thigh CT will be performed every 4 cm starting at the patella and ending at the femoral head (Siemens Somatom Sensation 64 Scanner) to quantify skeletal muscle area, total fat area, low density lean tissue area, and muscle attenuation of the thigh. Scans will be analyzed using MIPAV (Medical Image Processing, Analysis and Visualization, v.7.0, NIH). The cross-sectional area of each axial slice will be multiplied by the distance between slices (4 cm) and summed across slices representing volume expressed in cm3. The average attenuation of muscle tissue and the percentage of low-density lean muscle to total muscle volume is associated with skeletal muscle lipid (fat) content, and a measure of muscle quality.

  11. Ancillary Study #1 - Strength [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    A Biodex System 3 PRO dynamometer will measure concentric isokinetic peak normalized joint torque over the entire range of motion (strength) for bilateral ankle plantarflexion-dorsiflexion and knee flexion-extension. Strength is measured in Newton-meters (Nm). Testing will utilize standardized positioning and joint motion excursions. Subjects will perform two blocks of three repetitions with a rest period between blocks.

  12. Ancillary Study #1 - Power [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    A Biodex System 3 PRO dynamometer will measure strength per unit of time (power) for bilateral ankle plantarflexion-dorsiflexion and knee flexion-extension. Power is measured in Watts (W). Testing will utilize standardized positioning and joint motion excursions. Subjects will perform two blocks of three repetitions with a rest period between blocks.

  13. Ancillary Study #1 - Bone mineral density (BMD) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    BMD will be estimated using DXA as described above. DXA of the contralateral (non-fractured) femur will be measured to yield measures of total hip and femoral neck BMD.

  14. Ancillary Study #1 - Bone geometry [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    Bone geometry will be measured with the Hip Structural Analysis (HSA) program. The program uses DXA images to derive cross-section dimensions at defined regions traversing the femur, i.e., narrow neck, intertrochanter, and proximal shaft. At each region, BMD, bone cross-sectional area (CSA), outer diameter, cross-sectional moment of inertia, section modulus, and centroid are measured. Estimates of average cortical thickness and buckling ratio are derived using assumptions of cross-section shape.

  15. Ancillary Study #1 - Bone turnover markers [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    Bone turnover markers. a) bone formation (serum aminoterminal propeptide of type 1 procollagen; P1NP) and b) bone resorption (serum cross-linked C-telopeptides of type I collagen; CTx-I) will be assessed.

  16. Ancillary Study #1 - Hormones [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    a) Total testosterone (T) will be measured using the liquid chromatography-tandem mass spectrometry (LCMS/MS) method. b) Estradiol (E2) (Ultra-sensitive E2) will be measured by ELISA. c) Insulin-like growth factor-1(IGF-1) will be measured by RIA, using acid ethanol extraction. d) SHBG will be measured by IRMA. e) 25-hydroxyvitamin D (25-OH D) will be measured by RIA using kits supplied by DiaSorin (Stillwater, MN). This assay detects both the D2 and D3, f) Parathyroid hormone, intact (iPTH) will be measured by ELISA.

  17. Ancillary Study #1 - Inflammatory cytokines [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    a) interleukin-6 (IL-6), b) soluble TNF- α receptor 1 (sTNF- αR1), c) IL-1 receptor antagonist (IL-1ra), and d) interleukin-10 (IL-10). All cytokines will me measured in serum by ELISA (R&D Systems Inc., Minneapolis, MN).

  18. Ancillary Study #1 - Aerobic capacity [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    VO2 peak will be measured using a treadmill with a custom constant velocity protocol with open circuit spirometry for measurement of aerobic capacity (Ametek-Thermox) O2 and CO2 analyzers (Sensormedics 2900 metabolic cart with re-breathing cardiac output option) using a method that has been previously employed in subjects with hemiparetic stroke recent hip fracture.

  19. Ancillary Study #1 - Gait and balance (GAITrite) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    A GAITrite instrumented walkway system will measure spatial and temporal gait parameters. Subjects will walk at their safest fast and natural speeds. In addition, the Dynamic Gait Index, a clinical assessment of balance and mobility while walking, will be administered. Measures will include: step length, walking speed, single and double leg support time, and cadence.

  20. Ancillary Study #1 - Gait and balance (Stepping Test) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    Subjects will stand on two separate force platforms with reflective motion detection markers placed on each foot to record stepping kinematics. Visually cued simple and choice stepping reaction time (RT) tasks will evaluate the rapid initiation of forward stepping. Measures will be response, weight transfer, and movement times, number of false starts and stepping performance. Neuromotor and biomechanical features of balance and gait control will be extracted.

  21. Ancillary Study #1 - Gait and balance (Four Square Step Test) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    It was developed as an easily portable and reliably scored test of balance and ambulatory coordination, and standardized locally according to detailed usage in the literature. Essentially, the subject is timed while stepping into "4 squares" over lines or canes placed on the floor in a "+" pattern moving both clockwise then back counter-clockwise. This will be performed by an exercise physiologist or nurse experienced in its application, using an SOP that has been reviewed by PTRS faculty. The rationale for including this test in addition to the more mechanistic gait and stepping tests above includes its well established clinical relevance and ease of interpretation of change in score over time.

  22. Ancillary Study #1 - Cognitive function (Trail Making Test (Trails A & B)) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. It is sensitive to detecting cognitive impairment associated with dementia.

  23. Ancillary Study #1 - Cognitive function (Hooper Visual Organization Test (VOT)) [ Time Frame: 16 weeks post-randomization and 40 weeks post-randomization for a subset of participants ]
    The Hooper VOT is a neuropsychological test of visual spatial ability that presents participants with a line drawing of a common object that has been broken into fragments, and asks participants to name what the object would be if reassembled.

  24. Ancillary Study #2 - Food Frequency Questionnaire (FFQ) [ Time Frame: Baseline ]
    Data collected from the Harvard FFQ includes foods, food groups, and frequency of intake that is averaged by respondents to represent intake over the previous year. This questionnaire is validated against diet record for correlations between nutrients and food intake. Participants will complete the FFQ at home, on their own time. Instructions for completion will be altered to report intake since their hip fracture.

  25. Ancillary Study #2 - 24 Hour Dietary Recall [ Time Frame: Baseline ]
    The diet record (DR) provides a snapshot of current intake. The 7-day weighted DR is considered the gold standard for subjective dietary assessment and the 24 hour DR has been validated in older adults. Participants will record all foods and beverages eaten, the amount consumed and time of consumption in the previous 24 hours. Food models, scales, and examples will be provided to guide the participant to most accurately report intake. Participants will be asked if the 24 hour DR is representative of their intake prior to hip fracture.

  26. Ancillary Study #2 - Food Barriers and Motivators Survey [ Time Frame: Baseline ]
    To assess potential reasons for poor intake or post-hip fracture alterations in their eating behaviors, investigators will inquire about barriers and motivators of food intake including: food security, appetite and sensory appeal, oral health, perception of health and resources, and social factors. To meet the needs of this study, investigators will modify other validated surveys. Surveys used in the development of this survey include the Guide to Measuring Household Food Security from the USDA to assess food security; the Simplified Nutritional Appetite Questionnaire (SNAQ) to access appetite; Vailas' Food Enjoyment Questionnaire to identify barriers of intake; and the Food Choice Questionnaire (FCQ) to assess motivators of food intake.

  27. Ancillary Study #4 - Muscle thickness and quality [ Time Frame: Baseline, 16 weeks post-randomization, and 40 weeks post-randomization for a subset of participants ]
    There are no additional exclusion criteria for the ultrasound measures and no known risks associated with these measures as ultrasound does not use ionizing radiation to acquire images. Muscle quality (thickness and echo intensity) of the gluteus medius, rectus femoris, and lateral heads of the gastrocnemius will be measured using an ultrasound unit (GE - LOGIQ e). Participants will be in a private room and asked to lie in side-lying with their hip and lower leg exposed in order to measure the gluteus medius and lateral gastrocnemius. They will be draped with a sheet for modesty as necessary. Participants will then be asked to roll onto their backs with their front thigh exposed in order to measure the rectus femoris. Ultrasonographic images will be taken bilaterally. The images (which have no identifiers; only their study code) will be downloaded onto a computer and later analyzed using Image J.

  28. Ancillary Study #4 - Sit-to-stand (video and forceplate) [ Time Frame: Baseline, 16 weeks post-randomization, and 40 weeks post-randomization for a subset of participants ]
    Participants will do the sit-to-stand (STS) test from both a standard and adjustable height chair (adjusted to 80% of tibial length with shoes). Participants are instructed to place their arms across their chest throughout the STS maneuver. If unable to do this participants are allowed to use their arms. Participants' feet are placed parallel with each foot on a different forceplate with knees at a 90 degree angle; the width is unrestrained, but consistent throughout trials. The STS test includes 3 trials at the participant's preferred speed then 3 trials as fast as and as slow as possible with rest as needed. A video camera is positioned in the frontal and sagittal plane to record the strategy used to rise from the chair. Participants will come to standing onto forceplates that measure vertical ground reaction force under each leg, the rate at which they rise from the chair at three different speed commands, and the time range between fast and slow trials as a measure of capacity.

  29. Ancillary Study #4 - Lower extremity power (Primus) [ Time Frame: Baseline, 16 weeks post-randomization, and 40 weeks post-randomization for a subset of participants ]
    The participant will be placed on a machine (Primus) that will allow the measurement of lower extremity power during the "leg press exercise" movement. First, the participant will be given several practice trials and the test will only begin after they demonstrate understanding of the task. The participant will then be asked to do this movement against three different resistances (set to 30, 40, and 50% of body weight) for a total of up to 15 trials; 5 at each percentage of body weight. We will be looking for 3 trials that are consistent (≤ 5% coefficient of variation among trials) and as soon as this is done the participant will proceed to the next resistance level. In our pilot study with healthy elders (age range 58-88; 75 + 12 yrs) all participants were able to achieve 3 consistent trials within the specified five trials with no adverse events.

  30. Ancillary Study #4 - Temporospatial measures of walking (Gait Mat) [ Time Frame: Baseline, 16 weeks post-randomization, and 40 weeks post-randomization for a subset of participants ]
    Temporal and spatial characteristics of gait will be measured with the Gait Mat II (EQ, Inc., Telford, PA). The participant will be instructed to walk at usual, fast and as slowly as possible without stopping. Individually determined rest periods will be given between the trials. The Gait Mat II ™ is connected to a personal computer and collects average walking speed (m/sec) and calculates step length as the spatial distance between the location of the first switch closure of one footprint and the location of the first switch closure of the previous footprint on the contralateral side. Single support time is calculated as the time from the last switch opening of one step to the first switch closure of the next step. Left single support time is the same as right swing time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Closed fracture of proximal femur
  • Age 60 or older at time of randomization
  • Minimal trauma fracture
  • Non-pathologic fracture
  • Surgical fixation of fracture
  • Living in the community at time of fracture
  • Ambulating without human assistance 2 months prior to fracture
  • Unable to walk 300 m or more in 6 minutes without human assistance at time of randomization

Exclusion Criteria:

  • Not English speaking
  • Does not live within reasonable distance of the clinical center
  • End stage renal disease on dialysis
  • Recent myocardial infarction
  • Uncompensated congestive heart failure
  • Lower extremity amputation
  • Symptoms of angina pectoris
  • Chest pain or shortness of breath (including from severe COPD)
  • Participant plans to move out of area or otherwise be unavailable during the 16-week intervention period
  • Participation in another clinical trial
  • Not community-residing (e.g., resident of a skilled nursing facility) at time of randomization
  • Not fully weight-bearing on fractured leg or non-fractured leg at time of randomization
  • Calculated creatinine clearance < 15 ml/min
  • Serum albumin < 2.5 g/dl
  • Hemoglobin < 9 g/dl
  • Receiving physical therapy for the hip fracture in the hospital or inpatient rehabilitation facility at time of randomization
  • Severely diminished lower extremity sensation or ulceration
  • Uncontrolled hypertension
  • Denied medical clearance by appropriate medical provider
  • Clinical site clinician thinks participant is not a good candidate for study (e.g., not likely to survive study period)
  • Cognitive impairment (3MS score <73)
  • Development of chest pain or substantial shortness of breath or ambulating with severe pain during baseline SMWT
  • Participant walks less than 4 meters in 40 seconds (<0.1 m/sec) during baseline SMWT
  • Not randomized by 26 weeks post admission for hip fracture
  • Final sign-off from study clinician and/or principal investigator is incomplete
  • Incomplete baseline data
  • Unable to contact participant
  • Participant is unable to provide her/his own informed consent
  • Participant refuses the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783704


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
United States, New Hampshire
Dartmouth Medical School
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
Arcadia University
Glenside, Pennsylvania, United States, 19038-3295
Sponsors and Collaborators
University of Maryland
National Institute on Aging (NIA)
Arcadia University
UConn Health
Dartmouth-Hitchcock Medical Center
Investigators
Study Chair: Jay Magaziner, PhD, MSHyg University of Maryland
  Study Documents (Full-Text)

Documents provided by Jay S. Magaziner, University of Maryland:
Study Protocol  [PDF] October 19, 2016
Statistical Analysis Plan  [PDF] December 1, 2017


Publications:
Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston, Mass.: Nimrod Press; 1993.
Pescatello L, DiPietro L, Fargo A, Ostfeld A, Nadel E. The impact of physical activity and physical fitness on health indicators among older adults. Journal of Aging and Physical Activity 2: 2-13, 1994.
Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied psychological measurement 1: 385-401, 1977.
Zimmerman SI, Smith HD, Gruber-Baldini A, et al. Short-term persistent depression following hip fracture: a risk factor and target to increase resilience in elderly people. Social Work Research 23:187-96, 1999.
Bickel G, Nord M, Price C, Hamilton W, Cook J. Guide to Measuring Household Food Security, Revised 2000. In: U.S. Department of Agriculture FaNS, editor. Alexandria, VA 2000.

Responsible Party: Jay S. Magaziner, Professor and Chair, University of Maryland
ClinicalTrials.gov Identifier: NCT01783704     History of Changes
Other Study ID Numbers: HP-00046956
1R01AG035009-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jay S. Magaziner, University of Maryland:
hip fracture
randomized controlled trial
exercise

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries