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Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease (Strong Hearts App)

Primary Purpose

Congenital Heart Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strong Hearts Exercise Program
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring Child, Adult

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Repaired or unrepaired Congenital Heart Disease (CHD) Between ages 10 and 50, inclusive, at time of consent Android or Apple smartphone that meets the operating systems below with the ability to download applications from either Google Play or the Apple store Android: 6.0 or higher Apple: iPhone Operating System (iOS) 13 or higher Exclusion Criteria: Physical or mental disabilities preventing exercise participation Uncontrolled systemic hypertension (symptomatic or greater than Stage 2 hypertension while on therapy) Poorly controlled arrhythmia Clinically unstable heart failure Known pregnancy at the time of enrollment

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Group

Arm Description

Participants will participate in a remote, app-enabled exercise program consisting of strength and aerobic exercises for four to twelve weeks. They will perform the exercises 3-5 times a week at home guided by exercise videos in the app. The exercise sessions will increase in frequency throughout the training regimen. The videos will include athletes demonstrating how to perform each exercise safely, and provide tips for optimal form and breathing. Participants will wear wearable fitness trackers and monitor their heart rates during exercise sessions.

Outcomes

Primary Outcome Measures

Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing
Change in Pediatric Cardiac Quality of Life Inventory
The Pediatric Cardiac Quality of Life Inventory generates 3 scores (total, disease impact subscale, and psychosocial impact subscale). Each subscale has a maximum of 50 points and their sums yields the total score. Higher scores indicate better perceived health-related quality of life.
Change in Short Form 36 (SF-36) Health Survey
The Short Form 36 Health Survey consists of 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health). The survey will be scored using the two step RAND scoring process. The first step scores each question on a scale from 0 (worst) to 100 (best) and represents the percentage of total possible score achieved. The second scoring step, takes the average of all the questions in each subscale to create the 8 scores.
Change in sit-to-stand test

Secondary Outcome Measures

Full Information

First Posted
April 14, 2023
Last Updated
August 31, 2023
Sponsor
Duke University
Collaborators
Food and Drug Administration (FDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05853705
Brief Title
Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease (Strong Hearts App)
Official Title
Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Food and Drug Administration (FDA)

4. Oversight

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

5. Study Description

Brief Summary
The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart Disease (CHD). Pilot trials will consist of a remote exercise program with app-embedded exercise modules designed to promote and encourage safe and healthy exercise habits across a range of CHD anatomies. This app-enabled program will allow for real time data collection integrating wearable devices, as well as compliance and safety monitoring to enhance research capabilities. The app-enabled program will be versatile and may be applied in the future to patients with non-cardiac conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Child, Adult

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Participants will participate in a remote, app-enabled exercise program consisting of strength and aerobic exercises for four to twelve weeks. They will perform the exercises 3-5 times a week at home guided by exercise videos in the app. The exercise sessions will increase in frequency throughout the training regimen. The videos will include athletes demonstrating how to perform each exercise safely, and provide tips for optimal form and breathing. Participants will wear wearable fitness trackers and monitor their heart rates during exercise sessions.
Intervention Type
Behavioral
Intervention Name(s)
Strong Hearts Exercise Program
Intervention Description
The participant will either begin at the easiest variation of each strength exercise (level A), or will be placed at a specific level for each strength exercise based on their assessment with physical therapy. Participants can progress to the next level of difficulty of a specific strength exercise based on their rating of perceived exertion (RPE) with the opportunity to move to the next level if they have RPE score of 6 or less and if their heart rates are at goal. Each participant will be provided with heart rate ranges based on the heart rate reserve (HRR) method using their baseline resting and peak heart rates obtained during their cardiopulmonary exercise testing (CPET) or percent predicted heart rate based on age if CPET is not available. HRR goals will be set individually for patients and adjusted per protocol to guide effort.
Primary Outcome Measure Information:
Title
Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing
Time Frame
Baseline, up to 12 weeks
Title
Change in Pediatric Cardiac Quality of Life Inventory
Description
The Pediatric Cardiac Quality of Life Inventory generates 3 scores (total, disease impact subscale, and psychosocial impact subscale). Each subscale has a maximum of 50 points and their sums yields the total score. Higher scores indicate better perceived health-related quality of life.
Time Frame
Baseline, up to 12 weeks, 1 year
Title
Change in Short Form 36 (SF-36) Health Survey
Description
The Short Form 36 Health Survey consists of 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health). The survey will be scored using the two step RAND scoring process. The first step scores each question on a scale from 0 (worst) to 100 (best) and represents the percentage of total possible score achieved. The second scoring step, takes the average of all the questions in each subscale to create the 8 scores.
Time Frame
Baseline, up to 12 weeks, 1 year
Title
Change in sit-to-stand test
Time Frame
Baseline, up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Repaired or unrepaired Congenital Heart Disease (CHD) Between ages 10 and 50, inclusive, at time of consent Android or Apple smartphone that meets the operating systems below with the ability to download applications from either Google Play or the Apple store Android: 6.0 or higher Apple: iPhone Operating System (iOS) 13 or higher Exclusion Criteria: Physical or mental disabilities preventing exercise participation Uncontrolled systemic hypertension (symptomatic or greater than Stage 2 hypertension while on therapy) Poorly controlled arrhythmia Clinically unstable heart failure Known pregnancy at the time of enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefany Olague, MPH
Phone
9196688131
Email
smalltrials-CRC@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reid C Chamberlain, MD, MSCI
Organizational Affiliation
Duke UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Wood, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease (Strong Hearts App)

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