RECRUITING

Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

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Cardiac Rehabilitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-10-09
Study Completion:2024-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05826587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients referred to and who undergo early outpatient CR irrespective of diagnosis will be eligible for the study.
  2. * All participants must have access to a smart mobile device.
  1. * Advanced dementia.
  2. * Wheelchair bound.
  3. * Vision loss.
  4. * 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:
  5. * Standard early outpatient center-based supervised CR only (control; CR); or
  6. * 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).

Contacts and Locations

Study Contact

Robert Scales, PhD, MS
CONTACT
480-791-8935
scales.robert@may.edu

Principal Investigator

Robert Scales, PhD, MS
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Robert Scales, PhD, MS, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-09
Study Completion Date2024-11

Study Record Updates

Study Start Date2023-10-09
Study Completion Date2024-11

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiac Rehabilitation