Home Exercise And Resiliency Training (Heart) Club

Frailty Clinical Trial

Official title:

Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543733
• Other study ID #: HUM00220044
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Blake Armstrong
• Phone: 734-615-4899
• Email: blar[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will require two in-person visits to the exercise physiology lab as well as virtual follow-up visits. Visit one will require participants to complete a cardiopulmonary exercise test (CPET), liver ultrasound, 6-minute walk, grip strength test, arm circumference measure, body composition analysis, anthropometrics measurement, surveys and a biomarker blood sample collection. The second in-person visit will require participants to complete a final cardiopulmonary exercise test, liver ultrasound, 6-minute walk, grip strength test and arm circumference, biomarker blood sample and final survey.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fontan Physiology
• Frailty

Intervention

Behavioral:
• Home exercise program
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in 7-day average step count over 6 month period		Baseline, 6 months
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	This survey has 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable).	day 1 (baseline), week 26 (final visit)
Secondary	Change in 6-minute walk distance		day 1 (baseline), week 26 (final visit)
Secondary	Change in peak oxygen consumption	This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min).	day 1 (baseline), week 26 (final visit)
Secondary	Change in oxygen consumption at anaerobic threshold	This is measured during a CPET.	day 1 (baseline), week 26 (final visit)
Secondary	Change in liver stiffness measured by ultrasound	This is measured during ultrasound, units meters per second (m/sec)	day 1 (baseline), week 26 (final visit)
Secondary	Change in alpha fetoprotein (AFP)	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Secondary	Change in Aspartate Transferase (AST)	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Secondary	Change in Alanine Aminotransferase (ALT)	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Secondary	Change in platelets	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Secondary	Change in Gamma-glutamyl Transferase (GGT)	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Secondary	Change in Enhanced Liver Fibrosis (Elf) Score number	This is a blood sample.	day 1 (baseline), week 26 (final visit)