Home-based exercise program to prevent falls in cardiac rehabilitation patients
A Mobile-Health (mHealth) Fall Risk Prevention Intervention in Cardiac Rehabilitation: A Randomized Control Trial
This study tests if a home-based exercise program can help people in cardiac rehab improve their balance and strength to prevent falls.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT05826587 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of a structured home-based exercise program designed to enhance balance and muscle strength in patients undergoing cardiac rehabilitation. The program includes individualized therapeutic exercises delivered through a mobile health application, focusing on improving physical function and reducing fall risk. Participants will undergo comprehensive fall risk screening and physical function assessments before being randomized into either a standard rehabilitation group or an experimental group receiving the additional home-based training. The goal is to enhance the rehabilitation experience and improve daily living activities.
Who should consider this trial
Good fit: Ideal candidates include patients referred for early outpatient cardiac rehabilitation who have access to a smart mobile device.
Not a fit: Patients with advanced dementia, those who are wheelchair-bound, or have significant vision loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce fall risk and improve the quality of life for patients in cardiac rehabilitation.
How similar studies have performed: Other studies have shown positive outcomes with home-based exercise interventions in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients referred to and who undergo early outpatient CR irrespective of diagnosis will be eligible for the study. * All participants must have access to a smart mobile device. Exclusion Criteria: * Advanced dementia. * Wheelchair bound. * Vision loss. * Patients that underwent sternotomy within 12-weeks will be excluded from the upper body muscular strength/power assessment and associated upper body training. At the time of enrollment into CR, balance, upper body muscular fitness, and lower body muscular fitness will be assessed in each subject before they are randomized at a 1:1 allocation ratio into one of two parallel groups: * Standard early outpatient center-based supervised CR only (control; CR); or * Early outpatient center-based supervised CR plus individualized, home-based, m-Health delivered physical function training (experimental group; CR+PFt). Balance, upper body muscular fitness, and lower body muscular fitness and gait will be reassessed in each participant after 5-to-6 weeks of CR and again upon completion of the CR program. Patient reported measures of fall risk will be measured at baseline with the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit. Balance confidence, health-related quality of life, physical activity level, and functional capacity will be evaluated before and after CR and CR+PFt using the Activities-Specific Balance Confidence (ABC) Scale, the Dartmouth Primary Care Cooperative Information Project (COOP) charts, and the Duke Activity Status Index (DASI).
Where this trial is running
Scottsdale, Arizona and 1 other locations
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Robert Scales, PhD, MS — Mayo Clinic
- Study coordinator: Robert Scales, PhD, MS
- Email: scales.robert@may.edu
- Phone: 480-791-8935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.