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Working to Increase Stability Through Exercise (WISE)

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ClinicalTrials.gov Identifier: NCT02714257
Recruitment Status : Recruiting
First Posted : March 21, 2016
Last Update Posted : December 2, 2017
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of Pittsburgh
Temple University
Johns Hopkins University
Columbia University
University of Illinois at Chicago
Information provided by (Responsible Party):
Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

Brief Summary:

The investigators propose a 36-month multi-center randomized effectiveness trial to compare the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching (Exercise), on Fragility Fractures and Serious Fall-Related Injuries (FF/SFRI) in patients with a previous fragility fracture (FF).

The investigators will also examine the impact of the intervention on several secondary outcomes like: loneliness, physical function, and bone strength. The investigators will do this by following a Pragmatic trial design: 1) limiting exclusions to increase representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting measures to those practicable for use in usual care.


Condition or disease Intervention/treatment Phase
Fractures, Bone Behavioral: Enhanced Usual Care plus Exercise Coaching Not Applicable

Detailed Description:

The intervention will be held in churches, community centers, and senior residential facilities. Investigators will work with the exercise sites to recruit up to 125 individuals (5 per exercise site location) to serve as the Group leaders at each site location. Group leaders will be trained on the exercises and leadership roles to help lead the group. The investigators will ask them to come at least once per week, so the time commitment is minimal.

The investigators will be recruiting 2100 patients who have suffered a fragility fracture and will randomly assign them to one of two conditions: (A) Control Group - Enhanced Usual Care and (B) Intervention Group - Enhanced usual care plus Exercise coaching that includes in-person and phone coach contacts to encourage and support strength, balance and walking activities.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Integrating Patient-Centered Exercise Coaching Into Primary Care to Reduce Fragility Fracture
Study Start Date : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Enhanced Usual Care - control group
Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.
Experimental: Enhanced Usual Care plus Exercise Coaching Intervention
Participants will receive the three printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.
Behavioral: Enhanced Usual Care plus Exercise Coaching

For month one of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.

Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.

For the individuals exercising at home, the investigators will distribute the exercise Digital Versatile Disc (DVDs) every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.





Primary Outcome Measures :
  1. Number of Participants experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI) [ Time Frame: 36 months ]
    Every 4 months the investigators will call the participants asking questions about the main outcome, FF/SFI. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 4 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, physical exam notes, dictated radiologist notes and plain film radiography.


Secondary Outcome Measures :
  1. Number of falls and falls-related injuries using the Behavioral Risk Factor Surveillance System (BRFSS) [ Time Frame: 36 months ]
    The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.

  2. Assessment of Self-Reported Health using the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 36 months ]
    The investigators will use a self-reported health question to assess key patient centered outcomes that the intervention may improve. This question is from the NIH-supported PROMIS.

  3. Assessment of Body composition using Biomedical Impedance Analysis (BIA) [ Time Frame: 36 months ]
    The investigators will use BIA to estimate body composition during baseline and 36-month. It is a noninvasive procedure. BIA measures body fat, and provide an estimate of total body water (TBW). Using values of TBW we will be able to estimate fat-free mass (FFM) and body fat (adiposity).

  4. Blood Pressure [ Time Frame: 36 months ]
    Blood pressure will be measured by a research assistant using an automatic blood pressure monitor (Omron) and standard procedures.

  5. Body weight [ Time Frame: 36 months ]
    Body weight will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc)

  6. Assessment of Fear of Falling using the Falls Efficacy Scale International (FES-I) [ Time Frame: 36 months ]
    The investigators will use the 7-item version of the FES-I

  7. Osteoporosis and Other Medications Questionnaire [ Time Frame: 36 months ]
    At baseline, past osteoporosis medication use and duration will be obtained and, at each assessment time point, patients will be asked for their current list of medications. Medications specific to osteoporosis will be asked for by name (e.g., alendronate). In addition, for each osteoporosis medication, patients will be asked the start date, to estimate duration. The investigators will also search the electronic health record for any use of osteoporosis medications, in case they are not recalled by participants. Other medications will be asked at each time point as well, as certain medications (e.g., benzodiazepines) are known to strongly increase fall risk

  8. Assessment of fuctional lower extremity strengh using the 30 second chair Stand test [ Time Frame: 36 months ]
    At baseline and the 36 month follow-up the participants will perform the 30 seconf chair stand test. This will be used as a measure of functional lower extremity strength.

  9. Assessment of upper strenght using the 30 second arm curl test [ Time Frame: 36 months ]
    At baseline and the 36 months follow-up the participants will perform a 30 second arm curl test. The participants will be asked to use dumbbells (8 lbs for male and 5 lbs for female).

  10. Assessment of cognitive impairment using the Six-item Callahan screener [ Time Frame: 36 months ]
    Six-item screener will be used to identify cognitive impairment (6 questions total)

  11. Assessment of Physical Activity using the National Health Interview Survey (NHIS) [ Time Frame: 36 months ]
    The investigators will use 6 questions from the NHIS at baseline and the 36 month follow-up to measure participants' activity level. The survey identifies patients that are sedentary, moderately active, or very active.

  12. Assessing caregiver status [ Time Frame: 36 months ]
    The investigators will use two questions from the American Association of Retired People (AARP) Caregiver Identification Study, to identify whether the patient is a caregiver or not.

  13. Number of participants requiring hospitalization [ Time Frame: 36 months ]
    Every 4 months the investigators will call the participants asking questions about hospitalization. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 3 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, physical exam notes, dictated radiologist notes and plain film radiography.

  14. Number of participants requiring emergency department visits [ Time Frame: 36 months ]
    Every 4 months the investigators will call the participants asking questions about emergency department visit. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 3 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, physical exam notes, dictated radiologist notes and plain film radiography.

  15. Assessment of Physical Function using PROMIS [ Time Frame: 36 months ]
    The investigators will use 4 physical function questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

  16. Assessment of Fatigue using PROMIS [ Time Frame: 36 months ]
    The investigators will use 4 fatigue questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

  17. Assessment of Pain using PROMIS [ Time Frame: 36 months ]
    The investigators will use 5 pain questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

  18. Assessment of Sleep Disturbance using PROMIS [ Time Frame: 36 months ]
    The investigators will use 4 sleep disturbance questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

  19. Assessment of Ability to Participate in Social Roles and Activities using PROMIS [ Time Frame: 36 months ]
    The investigators will use 3 Ability to Participate in Social Roles and Activities questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

  20. Assessment of Depression using PROMIS [ Time Frame: 36 months ]
    The investigators will use 4 depression questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

  21. Assessment of Anxiety using PROMIS [ Time Frame: 36 months ]
    The investigators will use 4 anxiety questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

  22. Assessment of Loneliness using PROMIS [ Time Frame: 36 months ]
    The investigators will use 3 loneliness questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

  23. Assessment of Bone densitometry using dual energy X-ray absorptiometry (DXA) [ Time Frame: 36 months ]
    For Bone densitometry (BMD), bone mineral content (BMC, g) and bone area (BA, cm2) are measured for the total body, lumbar spine (L1-L4), and total hip (sum of the average femur neck, trochanteric region and proximal femoral shaft from dual-sided measurements). BMD (g m2) is calculated from the BMC and BA.

  24. Assessment of total Body soft tissues using DXA scan [ Time Frame: 36 months ]
    The investigators will measure total body soft tissue in terms of muscle (lean) mass and fat mass.

  25. Assessment of medical history using the Behavioral Risk Factor Surveillance System (BRFSS) [ Time Frame: 36 months ]
    The investigators will assess the prevalence of common chronic conditions (i.e., osteoarthritis, osteoporosis) using questions from the BRFSS.

  26. Height [ Time Frame: 36 months ]
    Height will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc)

  27. Self-reported assessment of Chronic conditions [ Time Frame: 36 months ]
    The investigators will ask 16 questions on chronic conditions, recent healthcare utilization, medical devices, hospital admissions, transportation, health insurance, home care, and nursing home/rehab facility stay.

  28. Assessment of Monitoring devices use. [ Time Frame: 36 months ]
    1 question related to the use of medical alert systems or personal emergency button use.

  29. Assessment of Late-life function using the Late-Life function and disability instrument (LLFDI) [ Time Frame: 36 months ]
    The investigators will ask 10 questions from the LLFDI about function - a person's ability to do discrete actions or activities.

  30. Assessment of Late-life disability using the Late-Life function and disability instrument (LLFDI) [ Time Frame: 36 months ]
    The investigators will ask 10 Questions from the LLFDI about disability-a person's performance of socially defined life tasks.

  31. Assessment of Home care services [ Time Frame: 36 months ]
    The investigators will ask 3 questions about use of home care services

  32. Assessment of Transportations [ Time Frame: 36 months ]
    The investigators will ask 1 question about ways of transportation the participant use.

  33. Assessment Health insurance use [ Time Frame: 36 months ]
    The investigators will ask 3 question about type of health insurance use

  34. Tobacco Use [ Time Frame: 36 months ]
    The investigators will ask 2 questions about tobacco use.

  35. Education status [ Time Frame: 36 months ]
    The investigators will ask 1 questions about education status.

  36. Socioeconomic status [ Time Frame: 36 months ]
    The investigators will ask 2 questions about socioeconomic status.

  37. Self-reported osteoporosis diagnosis [ Time Frame: 36 months ]
    The investigators will ask 2 questions about osteoporosis diagnosis.

  38. Date of Birth collection [ Time Frame: 36 month ]
    The investigators will ask participants their date of birth (month/date/year)

  39. Number of participants by gender [ Time Frame: 36 months ]
    The investigator will ask if the participant is a male or female

  40. Number of participants by Marital status [ Time Frame: 36 months ]
    The investigators will ask 1 question about marital status.

  41. Number of participants by race [ Time Frame: 36 months ]

    The investigators will ask participants if they fall in the following race categories:

    White Black or African American Asian Native Hawaiian or Other Pacific Islander American Indian or Alaskan Native More than one race Unknown/not reported


  42. Number of participants by ethnicity [ Time Frame: 36 months ]
    The investigators will ask participants if they are Hispanic or Latino.



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:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥ 65 years old
  • Previous Fragility Fracture (FF) in past 5 years.
  • Able to speak and understand English.
  • Participants will need to be willing to try exercising and agree to annual follow-up measurements.

Exclusion Criteria:

If the answer to the following questions are "yes", the investigators will exclude the participant from the study Do you feel pain in your chest, neck, jaw, or arms at rest, during your daily activities of living, OR when you do physical activity? Have you ever been told by a health professional that you should not exercise OR exercise only when supervised by a professional?

If the answer to the following questions are "yes", the investigators will contact physician for permission Do you experience unpleasant awareness of a forceful or rapid heart rate? Do you experience unreasonable breathlessness? Do you experience dizziness fainting or blackouts? Do you experience ankle swelling? Do you have burning or cramping sensation on your lower legs when walking short distances? Do you have diabetes?

Has a doctor, nurse or health professional ever told you that you had any of the following? Weak or failing kidneys? A heart attack, also called a myocardial infarction? Angina or coronary heart disease? A stroke? Any kind of heart condition or heart disease other than the ones I just asked about?

Unable to obtain primary care provider consent (if required based on questions above)

If the participant answer "NO" to the following question: Is it ok if the investigators contact your primary care provider?

If the participant answer "YES" to the following question:Have you been hospitalized for psychiatric problem in past year?

If the participant is planning on moving out of the area in the next 36 months

If currently participates in the Band Together exercise program

Positive Callahan cognition screener: If participant fails 2 questions, research coordinator will explain study in detail and ask read-back questions. The participant will be excluded if failed read-back.


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): NCT02714257


Contacts
Contact: Sol M Rodriguez-Colon, MS 717-531-0003 ext 281149 smr359@psu.edu

Locations
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Sol Rodriguez-Colon    717-531-7754    srodriguezcolon@hmc.psu.edu   
Contact: Abigail Fisher    717-531-7754    afisher7@hmc.psu.edu   
Principal Investigator: Christopher Sciamanna, MD, MPH         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Patient-Centered Outcomes Research Institute
University of Pittsburgh
Temple University
Johns Hopkins University
Columbia University
University of Illinois at Chicago
Investigators
Principal Investigator: Christopher Sciamanna, MD, MPH Milton S. Hershey Medical Center

Responsible Party: Christopher Sciamanna, MD, MPH, Prof. Medicine and Public Health Sciences, Division Chief Population Health Research and Development, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02714257     History of Changes
Other Study ID Numbers: IRB-3576
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries