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Behavioral Intervention

Remote Cardiac Rehabilitation for Congenital Heart Disease (Remote-CaRe Trial)

N/A

Recruiting

Led By David A White, PhD

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12-19 years old

Diagnosed with one of three congenital heart diseases: Univentricular heart with Fontan Palliation, Tetralogy of Fallot with transannular patch, Dextro-transposition of the great arteries with arterial switch operation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention

Awards & highlights

Remote-CaRe Trial Summary

This trial will compare the effectiveness of remote cardiac rehab (at home, supervised via video) vs. handouts on exercise for adolescents with CHD, to see if it improves cardiorespiratory fitness, cardiac function, and physical frailty.

Who is the study for?

Adolescents aged 12-19 with specific congenital heart diseases, internet access at home, and cleared for exercise by their cardiologist. They must be available for in-home exercises during weekdays and not have conditions like uncontrolled asthma or reliance on a pacemaker.Check my eligibility

What is being tested?

The trial tests if remote cardiac rehab via video conferencing is effective for adolescents with CHD. It compares live-supervised home exercise to an active control group receiving health handouts, measuring changes in fitness, heart function, body mass, and frailty over 12 weeks.See study design

What are the potential side effects?

Since the intervention involves physical exercise supervised remotely, potential side effects may include typical risks associated with physical activity such as muscle strain or fatigue. Specific risks related to participants' heart conditions will be monitored.

Remote-CaRe Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 19 years old.

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I have a specific type of congenital heart disease.

Remote-CaRe Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peak Cardiorespiratory Fitness

Secondary outcome measures

Echocardiogram with global longitudinal strain (Fontan)

Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)

Exercise session adherence (Remote Cardiac Rehab Group)

+10 more

Remote-CaRe Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Remote Cardiac RehabilitationExperimental Treatment1 Intervention

Following a 2-week ramp-up period, participants will attend group exercise sessions, remotely delivered in their homes, 3 days per week for 45-minutes over 12-weeks led by a live-interactive health coach. There are 4 exercise session types with different modalities: Session A: 75% aerobic, 25% resistance; Session B: 25% aerobic, 75% resistance; Session C: 50% aerobic, 50% resistance; and Session D: Exercise games (mix of modalities). Each participant will rotate through a 5-week set of exercise sessions (20 sessions) twice over the 10-weeks of group exercise period.

Group II: Active ControlActive Control1 Intervention

Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,582,946 Total Patients Enrolled

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,190,751 Total Patients Enrolled

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,725 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications are necessary for participation in this research project?

"Patients who suffer from congenital heart disease and are between the ages of 12-19 can apply to join this trial, which seeks 74 participants."

Answered by AI

Are there still opportunities for participation in this clinical trial?

"Confirming clinicaltrials.gov, this medical trial is actively looking for volunteers to participate and has been since August 31st of 2023 when the posting was first created. The information on the webpage was most recently revised at that same date."

Answered by AI

What is the current size of this clinical trial in terms of participants?

"Affirmative, the clinicaltrials.gov record reveals that this medical trial is currently enrolling participants. The study was first posted on August 31st 2023 and has not been updated since then; 74 patients need to be enrolled from 1 location."

Answered by AI

Is there an age restriction for individuals interested in participating in this research?

"Aged 12 to 19, individuals that fit the inclusion criteria for this trial can apply. On clinicaltrials.gov there are 107 studies pertaining to minors and 262 related to seniors aged 65 or above."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

David White 2023. "Remote Cardiac Rehab for Adolescents With Congenital Heart Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06015191.

All > Heart Disease