DOI: 10.3886/icpsr38919.v1
title: Integrating Patient-Centered Exercise Coaching into Primary Care to Reduce Fragility Fracture (WISE), Pennsylvania, 2016-2021
title: Version 1

description: Using a pragmatic trial design to limit exclusions, the investigators conducted 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. Specifically, the investigators examined the impact of the intervention on social loneliness, physical function, and bone strength. 1,139 individuals over 65 with a history of fragility fractures and/or osteoporosis were recruited over two years across three regions of Pennsylvania and randomized into either the enhanced usual care control group or exercise with coaching treatment group, where in-person exercise activities were led by trained volunteers.
Dataset (DS) 1 contains the following data used for analysis: participant characteristics at baseline by study group (referred to as Table 5 in the documentation), intervention participant characteristics at baseline based on exercise session type (referred to as Table 6), cumulative incidences of first serious fall-related injury compared by study group (referred to as Figure 3), cumulative incidence for first serious fall-related injury by age, gender, race, and osteoporosis medication (referred to as Table 8 and Figure 4), and cumulative incidence for first series fall-related injury by tertile of average intervention sessions per month (referred to as Figure 5). Other datasets used for analysis are fall injury data (DS2), monthly workout sessions data (DS3), secondary outcomes data (DS4, referred to as Table 7), and adverse events data (DS5, referred to as Table 9). DS6 includes markers designating before and after the start of the COVID-19 pandemic (March 11, 2020), allowing for analyses of participants who experienced fall-related injuries relative to COVID-19.
Datasets labeled "Miscellaneous" were not used in any analysis. These datasets contain extra measures from screening (DS7), baseline assessments (DS8), 4-month check-in visits (DS9), participant's distance to study site (DS10), coaching check-ins for weeks 1-12 (DS11), exercise sessions by month (DS12), adverse events (DS13), and end of study information (DS14).
description: The objectives of this study were:

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;
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
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
description: 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.
description: 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
description: 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.
description: 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)
description: 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%).
description: Datasets: 
DS0: Study-Level Files
DS1: Analytic Data: Baseline Characteristics, Subgroup Analysis, and Cumulative Incidences
DS2: Fall Injury Data
DS3: Monthly Workout Sessions Data
DS4: Secondary Outcome Variables over Time by Study Group Data
DS5: Adverse Events Data
DS6: Participant Study Start Relative to COVID-19 Pandemic
DS7: Miscellaneous Data: Screening
DS8: Miscellaneous Data: Baseline
DS9: Miscellaneous Data: 4-Month Visits
DS10: Miscellaneous Data: Distance to Study Site
DS11: Miscellaneous Data: Weekly Exercise Sessions
DS12: Miscellaneous Data: Monthly Exercise Sessions
DS13: Miscellaneous Data: Adverse Events
DS14: Miscellaneous Data: End of Study
description: Adults 65 and older with a history of bone fractures and/or osteoporosis living in Pennsylvania at the time of study.
description: record abstracts; mail questionnaire; on-site questionnaire; telephone interview