Clinical trial NCT05826587: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Change in self-reported physical function
timeFrame: Baseline, approximately 7 to 14 weeks
measure: Change in fall risk
timeFrame: Baseline, approximately 7 to 14 weeks
measure: Change in self-reported balance confidence
timeFrame: Baseline, approximately 7 to 14 weeks
measure: Change in health-related quality of life
timeFrame: Baseline, approximately 7 to 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Robert Scales, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: