RECRUITING

Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

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Conditions

Congenital Heart Disease in ChildrenExerciseCardiac RehabilitationPhysical ActivityTelehealth

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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 goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group. The RCR group will participate in live, group-based exercise training (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over 12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth video technology. The active control group will be provided informational handouts on health exercise for their cardiac diagnosis. The primary aim is to compare between group changes (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in physical function, quality of life, skeletal muscle function, and physical activity self-efficacy. Additionally, exploratory aims will explore the impact of demographic characteristics, program participation, program satisfaction, and daily physical activity on changes in cardiorespiratory fitness.

Official Title

Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease

Quick Facts

Study Start:2023-08-31
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06015191

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:12 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 12-19 years old
  2. 2. Male or Female
  3. 3. Diagnosed with one of three congenital heart diseases:
  4. 4. Primary Cardiology clearance for exercise participation
  5. 5. Internet access in their homes
  6. 6. Available for in-home exercise between 4-7pm on at least 3 days of the Monday-Friday work week
  7. 7. English Speaking
  8. 8. Achieving maximal effort on a cardiopulmonary exercise test, defined as RER ≥1.1 and/or in the judgement of the supervising exercise physiologist, a maximal effort was achieved but exercise capacity is limited by musculoskeletal deconditioning.
  1. 1. Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity
  2. 2. Participating in \> 15 MET-hours per week (mean weekly average over the past 12- months) of organized athletic/exercise activity (not including school physical education class).
  3. 3. Height less than 132cm
  4. 4. Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period.
  5. 5. Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test
  6. 6. Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise
  7. 7. Significant changes baseline echocardiogram or most recent clinical echocardiogram (from past clinical echocardiogram) such as decrease in ventricular and/or valvar function, new obstruction, or any new structural abnormalities
  8. 8. Uncontrolled or poorly controlled asthma
  9. 9. Presence of implanted cardioverter-defibrillator
  10. 10. Pacemaker with rate-responsive function initiated
  11. 11. Reliance on ventricular assist device
  12. 12. Prescribed milrinone medication
  13. 13. Listed for heart transplantation
  14. 14. Active engagement in hormone replacement for gender transition

Contacts and Locations

Study Contact

Dara Watkins, MA
CONTACT
816-302-3633
djwatkins@cmh.edu
David Cloutier, MS, MBA
CONTACT
816-302-3636
dacloutier@cmh.edu

Principal Investigator

David A White, PhD
PRINCIPAL_INVESTIGATOR
Children's Mercy Kansas City

Study Locations (Sites)

Children's Mercy Kansas City
Kansas City, Missouri, 64108
United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

  • David A White, PhD, PRINCIPAL_INVESTIGATOR, Children's Mercy Kansas City

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 Date2023-08-31
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-08-31
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Exercise
  • Cardiac Rehabilitation
  • Physical Activity
  • Telehealth

Additional Relevant MeSH Terms

  • Congenital Heart Disease in Children