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Home Exercise And Resiliency Training (Heart) Club

Primary Purpose

Fontan Physiology, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home exercise program
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fontan Physiology focused on measuring Exercise program, Liver stiffness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females with Fontan physiology
  • 18 years old at 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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home exercise program

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in 7-day average step count over 6 month period
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).
Change in 6-minute walk distance
Change in peak oxygen consumption
This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min).
Change in oxygen consumption at anaerobic threshold
This is measured during a CPET.
Change in liver stiffness measured by ultrasound
This is measured during ultrasound, units meters per second (m/sec)
Change in alpha fetoprotein (AFP)
This is a blood sample.
Change in Aspartate Transferase (AST)
This is a blood sample.
Change in Alanine Aminotransferase (ALT)
This is a blood sample.
Change in platelets
This is a blood sample.
Change in Gamma-glutamyl Transferase (GGT)
This is a blood sample.
Change in Enhanced Liver Fibrosis (Elf) Score number
This is a blood sample.

Full Information

First Posted
September 13, 2022
Last Updated
March 6, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05543733
Brief Title
Home Exercise And Resiliency Training (Heart) Club
Official Title
Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fontan Physiology, Frailty
Keywords
Exercise program, Liver stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home exercise program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Home exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Frailty score by the Fried frailty instrument
Description
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).
Time Frame
day 1 (baseline), week 26 (final visit)
Secondary Outcome Measure Information:
Title
Change in 7-day average step count over 6 month period
Time Frame
Baseline, 6 months
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29
Description
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).
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in 6-minute walk distance
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in peak oxygen consumption
Description
This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min).
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in oxygen consumption at anaerobic threshold
Description
This is measured during a CPET.
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in liver stiffness measured by ultrasound
Description
This is measured during ultrasound, units meters per second (m/sec)
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in alpha fetoprotein (AFP)
Description
This is a blood sample.
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in Aspartate Transferase (AST)
Description
This is a blood sample.
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in Alanine Aminotransferase (ALT)
Description
This is a blood sample.
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in platelets
Description
This is a blood sample.
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in Gamma-glutamyl Transferase (GGT)
Description
This is a blood sample.
Time Frame
day 1 (baseline), week 26 (final visit)
Title
Change in Enhanced Liver Fibrosis (Elf) Score number
Description
This is a blood sample.
Time Frame
day 1 (baseline), week 26 (final visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females with Fontan physiology 18 years old at 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blake Armstrong
Phone
734-615-4899
Email
blar@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Hansen, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blake Armstrong
Phone
734-615-4899
Email
blar@umich.edu
First Name & Middle Initial & Last Name & Degree
Jesse Hansen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Home Exercise And Resiliency Training (Heart) Club

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