NCT05543733

Brief Summary

The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2023Jul 2026

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

September 13, 2022

Last Update Submit

April 7, 2026

Conditions

FrailtyFontan Physiology

Keywords

Exercise programLiver stiffness

Outcome Measures

Primary Outcomes (1)

  • Change in Frailty score by the Fried frailty instrument

    The questionnaire evaluates five components of the frailty syndrome (weakness, slowness, shrinkage, exhaustion, and diminished physical activity). Sum of the components will have a possible score of 0-5: not frail (score 0), pre-frail (score 1-2), frail (score great or equal to 3), undetermined (missing component).

    day 1 (baseline), week 26 (final visit)

Secondary Outcomes (12)

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

    Baseline, 6 months

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

    day 1 (baseline), week 26 (final visit)

  • Change in 6-minute walk distance

    day 1 (baseline), week 26 (final visit)

  • Change in peak oxygen consumption

    day 1 (baseline), week 26 (final visit)

  • Change in oxygen consumption at anaerobic threshold

    day 1 (baseline), week 26 (final visit)

  • +7 more secondary outcomes

Study Arms (1)

Home exercise program

EXPERIMENTAL
Behavioral: Home exercise program

Interventions

Home exercise programBEHAVIORAL

Participants will complete a 6-month prescription telemedicine-based structured home exercise program. Baseline information will be used to develop a personalized home exercise program. This program will involve downloading the MyDataHelps application on a mobile device to securely collect wearable device information like step counts, activity minutes, and heart rate. Additionally, participants will have multiple virtual visits as well as the 2 in-person visits.

Home exercise program

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females with Fontan physiology
  • years old at age of enrollment

You may not qualify if:

  • Height less than 130 centimeter (cm)
  • Pregnancy or the plan to become pregnant during the study period
  • Current intravenous inotropic drugs
  • Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment
  • Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment
  • History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms)
  • Inability to complete exercise testing at baseline screening
  • Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jesse Hansen, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

March 1, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)