Integrating Patient-Centered Exercise Coaching into Primary Care to Reduce Fragility Fracture (WISE), Pennsylvania, 2016-2021 (ICPSR 38919)

Time Period(s) View help for Time Period(s)

Date of Collection View help for Date of Collection

Study Purpose View help for Study Purpose

The objectives of this study were:

1. To compare the effectiveness of exercise coaching with enhanced usual care in reducing serious fall-related injuries (SFRI), including fragility fractures from a fall, among older adults with a prior fragility fracture;
2. To compare the effectiveness of exercise coaching versus enhanced usual care on other patient-centered outcomes (loneliness, physical function, muscle strength, bone density, and muscle mass); and
3. To examine heterogeneity of treatment effects with regard to key participant factors, such as age, gender, race, ethnicity, osteoporosis medication use, and degree of intervention engagement, patient choice of exercise location

Study Design View help for Study Design

A pragmatic trial design was used to maximize participant eligibility and event (fall-related injury) rate. As such, exclusions were limited to increase representativeness, research contacts were limited to 30 minutes per year on average, and measures were limited to those practicable for use in usual care.

Enrollment occurred between December 2016 and November 2018. Study participants were recruited through multiple methods. Potential participants within a 25 mile radius of one of the site locations were found by searching for patients 65 and older with a history of fractures and/or osteoporosis via electronic health records (EHR), insurance claims data, medical registries, marketing companies, and partnerships with medical practices. Identified patients were sent mailed recruitment letters, followed by a phone call; if not interested in participating, patients were able to opt out by contacting the study team. Eligible participants were also recruited through community outreach strategies such as advertising in local media outlets, posters in common areas, direct mailers, informational presentations on bone health and falls reduction, social media, and creating a study website with recruitment videos and materials.

In addition to study participants, other individuals were recruited to serve as trained peer volunteers ("group leaders") to lead the in-person exercise sessions at 15 sites across Pennsylvania. 3-5 leaders were recruited per site and asked to commit to leading at least 1 session per week. Group leaders were recruited through community outreach methods or word of mouth. 55 group leaders were trained to lead exercise sessions.

Potential participants completed an initial screening by phone or in-person during community events, including taking blood pressure and heart rate measures. If eligible, researchers scheduled a baseline visit. Participants were sent assessments to be completed at home prior to the baseline visit. During the visit, researchers reviewed informed consent and took blood pressure and heart rate measures. Once individuals agreed to participate and were enrolled, researchers took baseline measurements and reviewed medications. Participants received $25 for completing the baseline visit. If authorized by their primary care providers, participants also received a dual-energy X-ray absorptiometry (DXA) scan to measure bone density and body composition.

Group leaders completed a 6-hour training session that included information about the program exercises, leading sessions, safety, and research ethics. Group leaders received $50 for completing the baseline visit training.

Following the baseline visit, researchers randomized participants into either the control or intervention group. Randomization was stratified by study site, gender, and whether the participant had ever taken osteoporosis medication. The control group received enhanced usual care. Participants were given pamphlets on fall risks and exercising and received recommendations to exercise from the research team. The intervention group received the same information as the control group, but were enrolled in an exercise program with individualized coaching offering feedback, regular progress reports, and exercise trackers. Exercise sessions were held three times a week (50 minutes long) in either community settings or at study sites, incorporating strength, balance, and aerobic exercises. A DVD option was also provided for participants who wished to follow the exercise program at home. Exercise coaches contacted patients for weekly check-ins during the first month, bi-weekly after 1 month, then monthly after 2 months. To assess outcomes, all randomized participants were contacted by phone every 4 months. At 36 months, randomized participants completed a 1-hour follow-up visit for final assessments.

Sample View help for Sample

Inclusion criteria for participants included age 65 years old or older, a previous fragility fracture (FF) within the past 10 years, and ability to speak and understand English. Exclusion criteria included inability to walk 100 feet without an assistive device; having been told by a health professional that they should not exercise, or that exercise should only be done under professional supervision; if the participant planned to permanently move out of one of the recruitment areas within the next 36 months; if they were currently participating in the Band Together exercise program; or if they screened positive on the Callahan cognition/dementia screener. The research team sought physician permission if the participant experienced one or more of the following: forceful or rapid heart rate; unreasonable breathlessness; dizziness, fainting, or blackouts; ankle swelling; burning or cramping in the lower legs when walking short distances; diabetes; kidney problems; heart disease or heart attack; or stroke.

The final sample was 1,139 participants enrolled and randomized, 569 in the control group and 570 in the intervention group. Most participants were non-Hispanic White (91.4%), 75 years old or younger (64.3%), female (84.4%), and college-educated (54.9%).

Time Method View help for Time Method

Universe View help for Universe

Adults 65 and older with a history of bone fractures and/or osteoporosis living in Pennsylvania at the time of study.

Unit(s) of Observation View help for Unit(s) of Observation

Data Type(s) View help for Data Type(s)

Mode of Data Collection View help for Mode of Data Collection

Description of Variables View help for Description of Variables

• Outcome measures: physical strength (bicep curl, chair stands), self-reported health, physical functioning (pain interference with everyday activities, sleep disturbance, fatigue), mental health (anxiety, depression), life satisfaction, social loneliness/isolation, number of serious fall-related injuries/bone fractures
• Body measures: height, weight, BMI, blood pressure, heart rate
• Intervention measures: number of workouts completed per month, exercises completed, weekly coaching check-ins
• Health history measures: smoking, medication use, osteoporosis, high blood pressure/hypertension, previous serious fall-related injuries
• Demographics: age, sex, race, ethnicity, marital status, education level

Response Rates View help for Response Rates

A total of 6,818 phone screening interviews were conducted. 2,854 individuals were ruled ineligible, with the main reasons being not having a fragility fracture in the past 10 years and inability to walk 100 feet. 2,825 individuals declined to enroll; about 40% did not give a specific reason, but when one was given, the main concerns were not feeling healthy enough to participate, transportation, and length of time commitment.

Presence of Common Scales View help for Presence of Common Scales

• Patient Reported Outcomes Measurement Information System (PROMIS)
• Falls Efficacy Scale International (FES-I)
• 30 second chair Stand test
• 30 second arm curl test
• Six-item Callahan screener
• National Health Interview Survey (NHIS)
• Dual energy X-ray absorptiometry (DXA)
• Behavioral Risk Factor Surveillance System (BRFSS)
• Late-Life Function and Disability Instrument (LLFDI)

Original Release Date View help for Original Release Date

2024-04-04

Version History View help for Version History