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Group Exercise Program for Heart Transplant Recipients (MIGHTEE Trial)

N/A
Waitlist Available
Led By Jonathan Edelson, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 12-18 years old
Patients must have access to an electronic device (phone, tablet, or computer) with a camera feature, microphone, and the capacity to use Zoom for virtual group exercise sessions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

MIGHTEE Trial Summary

This trial will test a remote, video-based aerobic training program to see if it's feasible and if it increases physical activity in heart transplant recipients.

Who is the study for?
This trial is for adolescents aged 12-18 who had a heart transplant over a year ago. They must be able to exercise, have internet access for remote group sessions, and speak English at least at a 5th-grade level. Those with conditions preventing exercise, recent medication changes affecting the heart rate, or pacemakers can't join.Check my eligibility
What is being tested?
The study tests if a 16-week remote aerobic training program via video-conferencing can increase physical activity in teens after heart transplantation. It aims to evaluate the feasibility of this virtual group exercise regimen.See study design
What are the potential side effects?
Since this trial involves an exercise program rather than medication, typical drug side effects are not expected. However, participants may experience general exertion-related issues such as muscle soreness or fatigue.

MIGHTEE 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 18 years old.
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I have a device with a camera and microphone for Zoom.

MIGHTEE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Study feasibility assessed by participants' engagement with exercise physiologist
Study feasibility assessed by participation in training sessions
Study feasibility evaluated by participants' engagement on the activity monitor application
Secondary outcome measures
Health Related Quality of life
Participants' overall program satisfaction
Perceived exercise barriers or exercise barriers
+2 more

MIGHTEE Trial Design

1Treatment groups
Experimental Treatment
Group I: Virtual group aerobic training programExperimental Treatment1 Intervention
16-week, virtual group aerobic training program led by exercise physiologist. Duration: 24 weeks. Four weeks recording of baseline activity through activity monitor; 16-week virtual group aerobic training program, 3 times per week for 30 minutes; and four weeks of follow-up.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,279 Total Patients Enrolled
Jonathan Edelson, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

Media Library

Group Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT05398744 — N/A
Heart Transplant Research Study Groups: Virtual group aerobic training program
Heart Transplant Clinical Trial 2023: Group Exercise Program Highlights & Side Effects. Trial Name: NCT05398744 — N/A
Group Exercise Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05398744 — N/A

Frequently Asked Questions

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

Could you elucidate the primary aims of this experiment?

"The primary endpoint of this clinical trial, assessed over a period of 24 weeks, is evaluating participant adherence to exercise regimes. Secondary goals encompass measuring physical activity with target heart rates and psychological wellbeing via Patient Reported Outcome Measurement Information System (PROMIS) T-scores. Finally, program satisfaction will be gauged by participants' post-intervention feedback surveys."

Answered by AI

Are there still opportunities for individuals to join this investigation?

"Affirmative, clinicaltrials.gov serves as a source of this medical study's active recruitment status. Posted on July 13th 2022 and last updated two weeks later, the trial seeks to recruit 30 participants from one specific location."

Answered by AI

How many participants are engaged in this research project?

"Exactly. Clinicaltrials.gov attests that this clinical trial, which was initiated on July 13th 2022, is actively recruiting candidates. 30 participants need to be recruited from 1 site for the experiment to continue."

Answered by AI

Is this research trial open to octogenarians?

"This research study is open to adolescents between the ages of 12-18."

Answered by AI

Am I qualified to register in this research endeavor?

"For consideration, those applying for this trial should have already undergone a heart transplant and be between the ages of 12-18. Altogether 30 participants will be accepted into the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study
2022. "Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05398744.
~1 spots leftby Jun 2024
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