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Supervised Exercise for Single Ventricle Heart Condition

Q: How can I sign up to participate in this research?

Eligible patients must have a common ventricle and be between the ages of 9-19. Up to 150 people will be enrolled in this clinical trial.

Q: Are people above the age of 25 years old eligible to participate in this clinical trial?

In order to participate in this clinical trial, patients must be between the ages of 9 and 19. Out of the 20 total studies, 15 are for people younger than 18 years old and 5 are for those who are 65 or older.

Q: Can more people still join this trial or has it reached full capacity?

The clinicaltrials.gov website confirms that this study is still enrolling patients. The trial was originally announced on August 18th, 2020 and has since been updated on August 26th, 2022. They are looking for a total of 150 participants from 1 location.

Q: How many human test subjects are involved in this clinical research?

That is correct. The information on clinicaltrials.gov does show that this trial is currently looking for participants. This specific trial was posted on 8/18/2020 and updated as recently as 8/26/2022. They are recruiting for a total of 150 patients at 1 location.

N/A

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Presence of an adult at home during exercise sessions for patients <14 years old

Fontan palliation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 9 months, 12 months

Awards & highlights

Study Summary

This trial is testing whether an exercise intervention will improve cardiac and physical capacity, muscle mass, strength and function, and endothelial function in pediatric Fontan patients.

Who is the study for?

This trial is for children and teenagers aged 8-19 with a single ventricle heart condition who've had Fontan palliation. They must be able to fast overnight, speak English, have cardiac clearance to exercise, and if under 14, an adult must be present during exercise sessions.Check my eligibility

What is being tested?

The study tests whether a live-video-supervised exercise program can improve heart and physical capacity, muscle mass and strength, as well as endothelial function in pediatric patients with the Fontan palliation compared to usual care followed by the intervention.See study design

What are the potential side effects?

Since this trial involves an exercise intervention rather than medication or surgery, side effects may include typical risks associated with physical activity such as muscle soreness or strain but are generally minimal.

Eligibility Criteria

Inclusion Criteria

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

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I am under 14 and will have an adult with me during exercise sessions.

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I have undergone the Fontan procedure for heart disease.

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I am between 8 and 19 years old.

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I speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 9 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 9 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 9 months, 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in volume of Oxygen Consumed at Maximal Exertion

Trial Design

2Treatment groups

Experimental Treatment

Group I: Live-Video-Supervised Exercise Control ArmExperimental Treatment1 Intervention

Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the 3-month exercise intervention of live-video-supervised exercise sessions x3/week for 3 months.

Group II: Live Video-Supervised Exercise Intervention ArmExperimental Treatment1 Intervention

Patients randomized to exercise intervention at baseline will participate in live-video-supervised exercise sessions x3/week for 3 months, and then will follow a maintenance regimen for 6 months. During maintenance, patients will continue live-video-supervised exercise sessions, only x1/week, and will be instructed to exercise on their own x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,838 Previous Clinical Trials

47,851,504 Total Patients Enrolled

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,205 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

274 Previous Clinical Trials

80,385 Total Patients Enrolled

Media Library

Single Ventricle Heart Clinical Trial 2023: Live-Video-Supervised Exercise Intervention Highlights & Side Effects. Trial Name: NCT04195451 — N/A

Frequently Asked Questions

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

How can I sign up to participate in this research?

"Eligible patients must have a common ventricle and be between the ages of 9-19. Up to 150 people will be enrolled in this clinical trial."

Answered by AI

Are people above the age of 25 years old eligible to participate in this clinical trial?

"In order to participate in this clinical trial, patients must be between the ages of 9 and 19. Out of the 20 total studies, 15 are for people younger than 18 years old and 5 are for those who are 65 or older."

Answered by AI

Can more people still join this trial or has it reached full capacity?

"The clinicaltrials.gov website confirms that this study is still enrolling patients. The trial was originally announced on August 18th, 2020 and has since been updated on August 26th, 2022. They are looking for a total of 150 participants from 1 location."

Answered by AI

How many human test subjects are involved in this clinical research?

"That is correct. The information on clinicaltrials.gov does show that this trial is currently looking for participants. This specific trial was posted on 8/18/2020 and updated as recently as 8/26/2022. They are recruiting for a total of 150 patients at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Re-Energize Fontan

Seda Tierney 2020. "Re-Energize Fontan". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04195451.