Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

Official title

A Mobile-Health (mHealth) Fall Risk Prevention Intervention in Cardiac Rehabilitation: A Randomized Control Trial

Overview

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.

Interventions

• Behavioral Home-based, m-Health Delivered Physical Function Training
  An individualized home exercise physical function training will be prescribed. This would include 5 balance training exercises and 1-2 upper and lower-body muscular conditioning exercises (i.e., wall push-up and chair stand) prescribed 3 days/week over the course of a 6-week period. Subjects will be assigned exercises from 1 of 3 different levels of exercise progression based on performance during the baseline muscular fitness assessment (functional chair stand and static chest throw).
• Behavioral Cardiac Rehabilitation & Exercise Prescription
  Standard, clinically indicated cardiac rehabilitation and exercise program. Approximately 30 to 40 minutes of aerobic exercise within a prescribed rating of perceived exertion (RPE 11-14) and/or target heart rate and approximately 15 to 20 minutes of both upper and lower body resistance exercise up to three times per week for up to at least 12 weeks. In addition, subjects are provided with home exercise instructions, and will be expected to exercise for 30 to 60 minutes at home.
• Other Connected mHealth mobile application
  Mobile application that allows subjects to track their independent home exercise with the option of heart rate monitoring by connecting to an external heart rate monitoring device.

Primary outcome measures

• Change in self-reported physical function [Time frame: Baseline, approximately 7 to 14 weeks]
• Change in fall risk [Time frame: Baseline, approximately 7 to 14 weeks]
• Change in self-reported balance confidence [Time frame: Baseline, approximately 7 to 14 weeks]
• Change in health-related quality of life [Time frame: Baseline, approximately 7 to 14 weeks]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Mayo Clinic Arizona — Scottsdale
• Mayo Clinic Florida — Jacksonville

Identifiers

NCT: NCT05826587 · 23-001155

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗