Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

Mayo Clinic

Status: Enrolling

Conditions: Cardiac Rehabilitation

Treatments: Behavioral: Cardiac Rehabilitation & Exercise Prescription; Other: Connected mHealth mobile application; Behavioral: Home-based, m-Health Delivered Physical Function Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05826587

23-001155

Details and patient eligibility

About

The purpose of this research is to see if taking part in a structured exercise plan that is designed to improve balance and muscle strength and one that can done at home helps to improve the ability to perform standard physical tasks, confidence in balance, and health-related quality-of-life

Full description

Traditional cardiac rehabilitation programs typically prioritize aerobic exercise (e.g., walking, cycling, etc.) with much less emphasis on improving physical function and strength, which is very important in, for example, decreasing the risk of falling. Through this research, researchers will implement a comprehensive fall risk screening and physical function assessment supported with individualized therapeutic exercise(s). Researchers hope that this will decrease fall risk, enhance rehabilitation experience, and improve ability to perform tasks of daily living.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Control group of cardiac rehabilitation only

Active Comparator group

Treatment:

Other: Connected mHealth mobile application

Behavioral: Cardiac Rehabilitation & Exercise Prescription

Intervention group of additional balance and muscle strength training

Experimental group

Treatment:

Behavioral: Home-based, m-Health Delivered Physical Function Training

Other: Connected mHealth mobile application

Behavioral: Cardiac Rehabilitation & Exercise Prescription