Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

Not Applicable

Recruiting

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

• Registration Number: NCT05826587
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-24
• Study Start: 2023-10-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group of cardiac rehabilitation only	Connected mHealth mobile application	-
Intervention group of additional balance and muscle strength training	Home-based, m-Health Delivered Physical Function Training	-
Intervention group of additional balance and muscle strength training	Cardiac Rehabilitation & Exercise Prescription	-
Intervention group of additional balance and muscle strength training	Connected mHealth mobile application	-
Control group of cardiac rehabilitation only	Cardiac Rehabilitation & Exercise Prescription	-

Primary Outcome Measures

Name	Time	Method
Change in self-reported physical function	Baseline, approximately 7 to 14 weeks	Measured using the Duke Activity Status Index (DASI) a self-reported questionnaire to subjectively measure physical activity level and functional capacity. The questionnaire includes twelve questions with each question weighted differently to assign a total score. Functional capacity is graded based on the total score (i.e., Good = DASI \>31.95 or Poor = DASI \<31.95).
Change in fall risk	Baseline, approximately 7 to 14 weeks	Measured using the Stop Elderly Accidents, Deaths, and Injuries (STEADI) assessment component which consists of 12 closed-ended questions. A score \>4 is considered at risk for falling.
Change in self-reported balance confidence	Baseline, approximately 7 to 14 weeks	Measured using the Activities-Specific Balance Confidence Scale, a 16-item questionnaire that is scored with a Likert scale (0-100%). The subject is graded on level of confidence associated with fall risk while performing a range of daily activities with varying levels of difficulty. Higher scores greater confidence.
Change in health-related quality of life	Baseline, approximately 7 to 14 weeks	Measured using the Dartmouth Primary Care Cooperative Information Project (COOP), a nine-question quality of life survey. There are nine categories including: physical condition, emotional condition, daily work, social activities, change in condition, overall condition, social support, quality of life and pain. Subjects will be graded with a total and sub-category score. Total scores range from 9-45 and a lower total score indicates a higher quality of life.

Trial Locations

Locations (2)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States