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Home Exercise Program for Heart Condition

N/A

Recruiting

Led By Jesse Hansen, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months

Awards & highlights

Study Summary

This trial will test whether a structured home exercise program delivered via telemedicine can help people with Fontan heart physiology by reducing frailty and improving exercise capacity.

Who is the study for?

This trial is for adults with Fontan heart physiology who can exercise and aren't on IV heart drugs. It's not for those with severe heart issues seen in recent echocardiograms, under 130 cm tall, pregnant or planning pregnancy during the study, or have noncardiac conditions that could affect participation.Check my eligibility

What is being tested?

The trial tests a home exercise program delivered via telemedicine to see if it improves frailty and exercise capacity in people with Fontan physiology. It also examines whether this approach overcomes barriers to access and affects liver disease markers associated with Fontan.See study design

What are the potential side effects?

Since the intervention involves an exercise program, potential side effects may include typical workout-related discomforts such as muscle soreness or fatigue. However, specific risks related to individuals' pre-existing health conditions will be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 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 Frailty score by the Fried frailty instrument

Secondary outcome measures

Change in 6-minute walk distance

Change in 7-day average step count over 6 month period

Change in Alanine Aminotransferase (ALT)

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Home exercise programExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home exercise program

2017

Completed Phase 3

~870

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,378,005 Total Patients Enrolled

3 Trials studying Frailty

80 Patients Enrolled for Frailty

Jesse Hansen, MDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Frailty

30 Patients Enrolled for Frailty

Media Library

Home exercise program Clinical Trial Eligibility Overview. Trial Name: NCT05543733 — N/A

Frailty Research Study Groups: Home exercise program

Frailty Clinical Trial 2023: Home exercise program Highlights & Side Effects. Trial Name: NCT05543733 — N/A

Home exercise program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543733 — N/A

Frequently Asked Questions

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

Is recruitment for this experiment still open to enrollees?

"As advertised on clinicaltrials.gov, this medical experiment is not presently recruiting patients. Initially posted on the 1st of October 2022 and last edited on 13th September 2022, unfortunately it does not need any more participants right now; however, 147 other trials are enlisting volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Home Exercise And Resiliency Training (Heart) Club

Jesse Hansen 2023. "Home Exercise And Resiliency Training (Heart) Club". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05543733.