Actively Recruiting
A Mobile-Health Fall Risk Prevention Intervention in Cardiac Rehabilitation: A Randomized Control Trial
Led by Mayo Clinic · Updated on 2026-01-20
128
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients undergoing cardiac rehabilitation and aims to evaluate whether a structured home-based exercise program that improves balance and muscle strength can enhance the ability to perform daily physical tasks, boost confidence in balance, and improve quality of life. The study addresses the usual emphasis on aerobic exercise in cardiac rehab by adding targeted physical function and strength training to reduce fall risk and improve rehabilitation outcomes. Participants are randomly assigned to one of two groups: one receiving standard cardiac rehabilitation involving aerobic and resistance exercises both in the center and at home over approximately 12 weeks, and another group receiving the same standard care plus an individualized home exercise program delivered via a mobile health app. The home program includes balance exercises and upper and lower body strengthening exercises prescribed three times weekly for six weeks, with exercise intensity tailored based on initial fitness assessments. During the study, participants will undergo assessments of balance, muscle fitness, gait, and fall risk at baseline, after 5 to 6 weeks, and upon completing the cardiac rehab program. Patient-reported outcomes such as balance confidence, health-related quality of life, physical activity, and functional capacity are measured using validated tools. The study monitors changes from baseline to approximately 7 to 14 weeks in these measures to evaluate the effect of the intervention on physical function and fall risk.
CONDITIONS
Brief Title
Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients referred to and undergoing early outpatient cardiac rehabilitation regardless of diagnosis
- Must have access to a smart mobile device
- Adults aged 18 years and older
You will not qualify if you...
- Advanced dementia
- Wheelchair bound
- Vision loss
- Patients who underwent sternotomy within 12 weeks will be excluded from upper body strength assessment and related training components only during the study period but may still participate in other assessments and training
- Inability to perform balance, upper body, or lower body muscular fitness assessments before randomization is a factor for group assignment but not explicit exclusion from participation overall in the trial protocol described
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 weeks
Participants receive cardiac rehabilitation including aerobic and resistance exercise approximately 3 times per week for up to 12 weeks. Those in the intervention group also receive additional home-based mobile-health delivered physical function training with balance and muscle strength exercises prescribed 3 days per week for 6 weeks.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 2 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
R
Robert Scales, PhD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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