Working to Increase Stability Through Exercise (WISE)
Comparing Two Ways to Reduce Future Fall Injuries Among Older Adults Who Have Fallen - The WISE Study
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 Serious Fall-Related Injuries (SFI) 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 1130 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.
*Due to the COVID-19 pandemic, the in-person intervention was stopped in March, 2020 and a Zoom-based virtual intervention was introduced in April, 2020. Participants that join the Zoom-based virtual intervention are led by staffed exercise coaches.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 65 years old
- Previous Fragility Fracture (FF) in past 10 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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) rregular progress reports sent by coaches to primary care providers via fax/electronic health records every 6 months, to communicate the patient's progress.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Experiencing a Serious Fall-Related Injury (SFI)
Time Frame: 36 months
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Every 4 months the investigators will call the participants asking questions about the main outcome, SFI, defined as an injury which required medical care (e.g., fragility fractures, concussion).
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 prior 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.
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)
Time Frame: 36 months
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The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.
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36 months
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Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: 36 months
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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.
The outcome is categorized as excellent/very good health vs. good/fair/poor health as reported on the single question.
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36 months
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Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)
Time Frame: 36 months
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The investigators will use the 7-item version of the Falls Efficacy Scale International (FES-I), used to quantify fear of falling in 7 different scenarios.
Each item is scored 1-4, with higher scores being associated with greater fear.
Total sum score is reported, possible range 7-28.
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36 months
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Assessment of Physical Function Using PROMIS
Time Frame: 36 months
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The investigators will use 4 physical function questions to assess physical function subscale of PROMIS.
Each item ranges 1-5.
Total sum score is reported; higher scores are associated with lower levels of physical function.
Total sum score range, 4-20.
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36 months
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Assessment of Depression Using PROMIS
Time Frame: 36 months
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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.
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36 months
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Assessment of Anxiety Using PROMIS
Time Frame: 36 months
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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.
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36 months
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Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)
Time Frame: 36 months
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The investigators will use 3 questions from the NHIS at baseline and 36-month follow-up to measure participants' activity level.
The percentage of participants meeting guidelines to achieve >=150 minutes/week of moderate and vigorous physical activity and >=2 times/week of strength training is reported.
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36 months
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UCLA Brief Loneliness Scale
Time Frame: 36 months
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The investigators will use 3 loneliness questions to assess key patient centered outcomes that the intervention may improve.
These questions are from the UCLA Brief Loneliness Scale.
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36 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-3576
- PCS-1406-18325-EXT (Other Identifier: PCORI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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