Improving Community Ambulation After Hip Fracture (CAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Maryland
Sponsor:
Collaborators:
Arcadia University
University of Connecticut Health Center
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Jay S. Magaziner, PhD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01783704
First received: January 31, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

Hip fracture is a common problem among older individuals. This year in the United States approximately 350,000 people aged 65 and older will break a hip. Despite improvements in therapy, hip fracture can still result in decreases in the strength of bone and muscle, making it difficult to walk and perform daily activities.

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 5 months 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.


Condition Intervention
Hip Fracture
Dietary Supplement: Nutrition (D3, calcium, multivitamin, counseling)
Behavioral: PUSH
Behavioral: PULSE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Community Ambulation After Hip Fracture

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Ability to walk 300 meters or more in six minutes [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    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).[153,154] 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:
  • Endurance [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    To assess endurance, the SMWT (described above) will be used to obtain a continuous measure of total distance walked in six minutes.[157] 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.[154,155,157] It has been performed by elderly, frail and severely compromised participants who cannot perform standard maximal treadmill or cycle ergometry exercise tests.[31,158]

  • Balance [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    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).[159] 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.

  • Quadriceps muscle strength [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    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.[160] 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).[161-163] The peak force will be recorded for each of the three trials and the highest value will be used.

  • Lower extremity function [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    A modified version of the Physical Performance Test (mPPT)[164] 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.[68] 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.[22] 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.

  • Fast walking speed [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    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.

  • Cost effectiveness: health care utilization [ Time Frame: Every four weeks, up to 40 weeks post-randomization ] [ Designated as safety issue: No ]
    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 40 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.


Other Outcome Measures:
  • Activities of daily living (ADLs) [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    We will measure ADLs using the Pepper Assessment Tool for Disability (PAT-D)[170,171] 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.[172] 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).

  • Quality of life (SF-36) [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    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).[173] The measure has been validated as a generic measure of quality of life in many different populations, including patient and non-patient samples.[68,173-175]

  • Balance confidence [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    The Activities-specific Balance Confidence (ABC) scale[176] 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.[176,177] This measure has been used successfully in hip fracture patients.[32,178]

  • Yale Physical Activity Survey (YPAS) [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    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.[179] 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.[179,180] The YPAS has been used to estimate change in older adults in an exercise intervention program.[181]

  • Improvement in walking [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    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.[182,183]

  • Short Physical Performance Battery (SPPB) [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    The SPPB evaluates lower extremity performance in older persons based on timed short distance walk, repeated chair stands, and a set of balance tests.[183-185] 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.[183,185]

  • Depressive symptoms [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    Depressive symptoms will be measured using the 20-item Center for Epidemiologic Studies Depression (CES-D) scale,[186] which asks about depressive symptoms experienced in the previous week. There is evidence that recovery post-fracture is delayed in the presence of depression.[187-190] This scale ranges from 0-60 with higher scores indicating greater depression

  • Cognitive status [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    Cognitive status will be assessed at follow-up using the 3MS

  • Nutritional status [ Time Frame: 16 weeks post-randomization ] [ Designated as safety issue: No ]
    Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA®-SF),[6,191] a validated and widely used malnutrition screening tool.[191-194] 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 <8 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.[6,191]


Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. Over a 16-week period, participants receive 40 visits (on non-consecutive days) from a study PT (3 visits per week for the first eight weeks and2 visits a week during the second eight weeks). Visits take place in the participant's place of residence. Participants also receive the nutritional intervention for the duration of the 40-week study.
Dietary Supplement: Nutrition (D3, calcium, multivitamin, counseling)
All participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the 40-week study. Nutritional counseling is also provided. Participants are screened at time of randomization to assess nutritional risk using the Mini Nutritional Assessment-Short Form.[6] Those who score ≤11 (malnourished or at risk of malnutrition) at baseline and/or participants with serum albumin 2.5-3.5 g/dl receive a visit from a registered dietician (RD) within 7 days of randomization with follow-up a week later. Those screening in the normal range receive a phone call within 7 days of randomization from the RD to discuss the importance of calorie and protein intake. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the study 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). Over a 16-week period, participants receive 40 visits (on non-consecutive days) from a study PT (3 visits per week for the first eight weeks and 2 visits a week during the second eight weeks). Visits will take place in the participant's place of residence. Participants will also receive the nutritional intervention for the duration of the 40-week study.
Dietary Supplement: Nutrition (D3, calcium, multivitamin, counseling)
All participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the 40-week study. Nutritional counseling is also provided. Participants are screened at time of randomization to assess nutritional risk using the Mini Nutritional Assessment-Short Form.[6] Those who score ≤11 (malnourished or at risk of malnutrition) at baseline and/or participants with serum albumin 2.5-3.5 g/dl receive a visit from a registered dietician (RD) within 7 days of randomization with follow-up a week later. Those screening in the normal range receive a phone call within 7 days of randomization from the RD to discuss the importance of calorie and protein intake. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the study 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.

Detailed Description:

Despite improvements in medical management, significant residual disability remains in older persons after a hip fracture.1-3 The goal of current clinical practice is independent, safe household ambulation two to three months after surgery.4 Hip fracture-acquired dependency in functional activities of daily living persists well beyond three months post-surgery. One year after hip fracture, 20% of patients need help putting on pants, 50% need assistance to walk, and 90% need assistance to climb stairs.2 This residual disability indicates that current standard Medicare-reimbursed post-hip fracture rehabilitation (i.e., usual care) fails to return many patients to pre-fracture levels of function. In contrast to stroke and heart disease, other commonly occurring acute conditions in the older population, there are few intervention trials focused on decreasing disability following hip fracture. None of the trials for hip fracture has examined the effect of early post-fracture intervention on the ability to ambulate at a level required for independent function in the community (i.e., community ambulation). Thus, there is a paucity of evidence to justify extending medical management beyond usual care in persons following hip fracture to achieve community, rather than merely household, ambulation.

A randomized controlled trial (RCT) including 300 older adults who have experienced a hip fracture will be carried out at three clinical sites with half of the subjects receiving a specific multi-component intervention (PUSH) and the other half receiving a non-specific multi-component intervention (PULSE). Randomization of 300 participants meeting eligibility criteria will take place after post-acute rehabilitation ends, approximately 5 months (20 weeks) after admission to the hospital for hip fracture. The primary endpoint will be measured using the Six-Minute Walk Test (SMWT) at the end of the 16-week intervention period. The goal is to enable older adults who have experienced a hip fracture to recover sufficiently to become community ambulators.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
  • Non-stress fracture
  • Unilateral hip fracture
  • Surgical fixation of fracture
  • Living in the community at time of fracture
  • Orthopedic surgeon gives permission to contact patient
  • 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
  • History of moderate or severe dementia
  • Diagnosis of schizophrenia or other psychosis
  • End stage renal disease on dialysis
  • Active hepatitis, HIV infection, tuberculosis, or endocarditis
  • Cancer under active treatment with chemotherapy or radiation therapy
  • Total hip replacement or prior hip fracture on same side as study index hip fracture
  • Recent total hip replacement or hip fracture on the contra-lateral side
  • Recent total knee replacement, lower extremity fracture or surgery on lower extremity (either side)
  • History of stroke with residual lower extremity hemiplegia
  • Recent myocardial infarction
  • Uncompensated congestive heart failure
  • Parkinson's Disease that restricts participation
  • Multiple sclerosis that restricts participation
  • History of myasthenia gravis or amyotrophic lateral sclerosis
  • Lower extremity amputation
  • Morbidly obese (BMI >40)
  • Extremely underweight (BMI <17)
  • Severe sensory impairment (visual or hearing)
  • 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
  • Severe lower extremity pain with ambulation
  • Not community-residing (e.g., resident of a skilled nursing facility) at time of randomization
  • Non-weight bearing on 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 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 during baseline SMWT
  • Participant walks less than 4 meters in 40 seconds (<0.1 m/sec)during baseline SMWT
  • Not randomized by 20 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783704

Contacts
Contact: Denise Orwig, PhD 410-706-2406 dorwig@epi.umaryland.edu
Contact: Lynn M Lewis, MA 410-706-5144 llewis@epi.umaryland.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Richard Fortinsky, PhD    860-679-8069    fortinsky@uchc.edu   
Principal Investigator: Richard Fortinsky, PhD         
Sub-Investigator: Anne Kenny, MD         
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ann Gruber-Baldini, PhD    410-706-2444    abaldin@epi.umaryland.edu   
Sub-Investigator: Ann Gruber-Baldini, PhD         
Principal Investigator: Brock Beamer, MD         
United States, New Hampshire
Dartmouth Medical School Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
Arcadia University Recruiting
Glenside, Pennsylvania, United States, 19038-3295
Contact: Kathleen Mangione, PhD, PT, GCS    215-572-2861    mangionk@arcadia.edu   
Principal Investigator: Kathleen Mangione, PhD, PT         
Sub-Investigator: Rebecca Craik, PhD, PT         
Sponsors and Collaborators
University of Maryland
Arcadia University
University of Connecticut Health Center
Dartmouth-Hitchcock Medical Center
Investigators
Study Chair: Jay Magaziner, PhD, MSHyg University of Maryland
  More Information

No publications provided

Responsible Party: Jay S. Magaziner, PhD, Professor and Chair, University of Maryland
ClinicalTrials.gov Identifier: NCT01783704     History of Changes
Other Study ID Numbers: HP-00046956, 1R01AG035009-01A1
Study First Received: January 31, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014