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Remote Cardiac Rehab for Adolescents With Congenital Heart Disease (Remote-CaRe)

Primary Purpose

Congenital Heart Disease in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Cardiac Rehabilitation
Active Control
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease in Children focused on measuring Exercise, Cardiac Rehabilitation, Physical Activity, Telehealth

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 12-19 years old Male or Female Diagnosed with one of three congenital heart diseases: Univentricular heart with Fontan Palliation, Tetralogy of Fallot with transannular patch, Dextro-transposition of the great arteries with arterial switch operation Clearance for exercise from their primary cardiologist Internet access in their homes Available for in-home exercise between 3-7pm on at least 3 days of the Monday-Friday work week Exclusion Criteria: Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity Participating in more than 3-months of organized athletic/exercise activity with an intensity of 5.0 or more metabolic equivalents (METs) throughout the year (not including school physical education) Height less than 132cm Pregnancy or planned surgery or procedure within the 12-week study period Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise Significant changes baseline echocardiogram or most recent clinical echocardiogram (from past clinical echocardiogram) such as decrease in ventricular and/or valvar function, new obstruction, or any new structural abnormalities Unable to meet peak exercise test criteria of respiratory exchange ratio (RER) ≥1.1 Uncontrolled or poorly controlled asthma Presence of implanted cardioverter-defibrillator Significant reliance on pacemaker (atrial or ventricular pacing ≥50%) Reliance on ventricular assist device Prescribed milrinone medication Listed for heart transplantation

Sites / Locations

  • Children's Mercy Kansas CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remote Cardiac Rehabilitation

Active Control

Arm Description

Following a 2-week ramp-up period, participants will attend group exercise sessions, remotely delivered in their homes, 3 days per week for 45-minutes over 12-weeks led by a live-interactive health coach. There are 4 exercise session types with different modalities: Session A: 75% aerobic, 25% resistance; Session B: 25% aerobic, 75% resistance; Session C: 50% aerobic, 50% resistance; and Session D: Exercise games (mix of modalities). Each participant will rotate through a 5-week set of exercise sessions (20 sessions) twice over the 10-weeks of group exercise period.

Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.

Outcomes

Primary Outcome Measures

Peak Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed using a peak cardiopulmonary exercise stress test (VO2peak) on a cycle ergometer using a ramping cycle protocol.

Secondary Outcome Measures

Echocardiogram with global longitudinal strain (Fontan)
Cardiac Function for the participant with Fontan diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained of the single left ventricle, right ventricle or the entirety of the biventricular morphology. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, or 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.
Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)
Cardiac Function for the participant with Tetralogy of Fallot and d-transposition of the great vessels diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained on the ventricles. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, and 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.
Lean Body Mass
Body composition will be assessed using whole-body dual energy X-ray absorptiometry (DXA)
Frailty (slowness)
Slowness will be assessed using a 6-minute walk test
Frailty (weakness)
Weakness will be assessed using handgrip strength dynamometry.
Frailty (fatigue)
Fatigue will be assessed using the Pediatric quality of life inventory (PedsQL) Multidimensional Fatigue Scale (Range: 0 (high fatigue) - 100 (low fatigue))
Frailty (energy expenditure/physical activity)
Physical activity / energy expenditure will be assessed using the self-report, past-week Physical Activity Questionnaire for Adolescents (PAQ-A) (Range: 1 (inactive) - 5 (highly active))
Functional Movement
Functional Movement / gross motor proficiency will be assessed with the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Range: -3SD (well-below average) - +4SD (well-above average)) SD = Standard deviations
Quality of Life Generic Core Scale
Quality of life (QoL) will be assessed with the Pediatric Quality of Life inventory (PedsQL) Generic Core Scale (Range: 0 (low QoL) - 100 (high QoL))
Quality of Life Cardiac Module
Cardiac specific quality of life (QoL) will be assessed with the Pediatric Quality of Life inventory (PedsQL) Cardiac Module (Range: 0 (low QoL) - 100 (high QoL))
Physical Activity Self-Efficacy
Physical activity (PA) self-efficacy will be assessed using the Domain-Specific Physical Activity Efficacy Questionnaire (mean score of 0 (low PA self-efficacy) - 100 (high PA self-efficacy)
Exercise session adherence (Remote Cardiac Rehab Group)
Exercise session adherence will be assessed using a wrist-worn Fitbit Versa 4 activity monitor. The Fitbit Versa 4 will be used to asses exercise heart rates during the exercise sessions.
Lifestyle Physical Activity
Physical activity will be assessed using a wrist-worn Fitbit Versa 4 activity monitor. The Fitbit Versa 4 will be used to determine the volume of physical activity participation in free-living conditions.

Full Information

First Posted
May 5, 2023
Last Updated
August 31, 2023
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of Kansas, Children's Hospital of Philadelphia, University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT06015191
Brief Title
Remote Cardiac Rehab for Adolescents With Congenital Heart Disease
Acronym
Remote-CaRe
Official Title
Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of Kansas, Children's Hospital of Philadelphia, University of North Carolina, Chapel Hill

4. Oversight

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

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group. The RCR group will participate in live, group-based exercise training (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over 12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth video technology. The active control group will be provided informational handouts on health exercise for their cardiac diagnosis. The primary aim is to compare between group changes (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in physical function, quality of life, skeletal muscle function, and physical activity self-efficacy. Additionally, exploratory aims will explore the impact of demographic characteristics, program participation, program satisfaction, and daily physical activity on changes in cardiorespiratory fitness.
Detailed Description
This randomized controlled trial will evaluate the effectiveness of live, in-home, group-based cardiac rehabilitation (CR) exercise training compared to standard care (active) control. Participants will include adolescents (age 12-19 years) with one of three congenital heart disease (CHD) diagnoses: Fontan (single ventricle) circulation, Tetralogy of Fallot, or dextro-transposition of the great vessels. Following baseline outcomes testing, participants will be computer randomized (with equal stratification by CHD diagnosis and biologic sex) to either the remote cardiac rehab (RCR) group (n=~37) or the active control group (n=~37). Participants randomized to the RCR group will participate in 12-weeks of live-supervised exercise training (36 sessions total) from their respective homes led by a trained health coach via telehealth video technology. RCR participants will initially engage in a 2-week ramp-up period (1-1 or small groups, 6-sessions total) with a live health coach, followed by 10-weeks of group-based (3-5 participants, 30 sessions total) exercise training where participants will be able to interact with the health coach and other participants. Participants in the RCR group will be asked to attend and participate in exercise sessions 3 days per week for 45-minutes. Exercise session intensity will be consistent with a heart rate of 60-75% of their VO2peak, will consist of a mix of flexibility, aerobic, and anaerobic exercise, and will be facilitated by a small set of exercise equipment (e.g., resistance bands, cones, medicine balls) provided to participants. Participants randomized to the active control group will be provided handouts that describe exercises consistent with the physical activity recommendations for youth. The total intervention period for both groups will be 12-weeks. Primary, secondary, and exploratory outcomes will be measured at baseline and 12-13-weeks following randomization. Additionally, participants in both groups will be provided a consumer grade wrist-worn physical activity monitor, where participants will be encouraged to wear throughout the 12-week intervention period and beyond for a minimum of 6-months. Participants randomized to the active control group will be provided the opportunity to participate in the RCR exercise training once enrollment goals are met.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease in Children
Keywords
Exercise, Cardiac Rehabilitation, Physical Activity, Telehealth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Cardiac Rehabilitation
Arm Type
Experimental
Arm Description
Following a 2-week ramp-up period, participants will attend group exercise sessions, remotely delivered in their homes, 3 days per week for 45-minutes over 12-weeks led by a live-interactive health coach. There are 4 exercise session types with different modalities: Session A: 75% aerobic, 25% resistance; Session B: 25% aerobic, 75% resistance; Session C: 50% aerobic, 50% resistance; and Session D: Exercise games (mix of modalities). Each participant will rotate through a 5-week set of exercise sessions (20 sessions) twice over the 10-weeks of group exercise period.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.
Intervention Type
Behavioral
Intervention Name(s)
Remote Cardiac Rehabilitation
Other Intervention Name(s)
RCR
Intervention Description
Participants will engage in a ramp-up period (weeks 0-2) where participants will attend 1-on-1 live, remote in-home exercise sessions (20-35 min./session, 3-days/wk.) delivered by a health coach via telehealth video conferencing. Participants will be provided a tablet computer and a small set of equipment. Following the ramp-up period, participants will be asked to attend live, in-home, group-based exercise sessions (weeks 3-12, 3-5 participants/group, 45-min, 3-days/wk. minimum). Sessions will be offered 4-days/wk. in the afternoons and early evenings allowing participants to select the most convenient 3 days per week to attend. Sessions will include a variety of dynamic aerobic and anaerobic (resistance) exercises with a target heart rate corresponding to 60-75% of VO2peak. In the group-based exercise sessions, participants will be able to see, hear, and verbally interact with the health coach and the other participants, allowing for supervision and encouraging social support.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.
Primary Outcome Measure Information:
Title
Peak Cardiorespiratory Fitness
Description
Cardiorespiratory fitness will be assessed using a peak cardiopulmonary exercise stress test (VO2peak) on a cycle ergometer using a ramping cycle protocol.
Time Frame
Change from baseline to 12-weeks
Secondary Outcome Measure Information:
Title
Echocardiogram with global longitudinal strain (Fontan)
Description
Cardiac Function for the participant with Fontan diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained of the single left ventricle, right ventricle or the entirety of the biventricular morphology. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, or 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.
Time Frame
Change from baseline to 12-weeks
Title
Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)
Description
Cardiac Function for the participant with Tetralogy of Fallot and d-transposition of the great vessels diagnosis will be assessed with echocardiogram using greyscale 2-dimensional images obtained on the ventricles. Global longitudinal strain analysis will be performed by averaging the apical 4, 3, and 2 images using GE EchoPAC BT13 software following American Society of Echocardiography guidelines.
Time Frame
Change from baseline to 12-weeks
Title
Lean Body Mass
Description
Body composition will be assessed using whole-body dual energy X-ray absorptiometry (DXA)
Time Frame
Change from baseline to 12-weeks
Title
Frailty (slowness)
Description
Slowness will be assessed using a 6-minute walk test
Time Frame
Change from baseline to 12-weeks
Title
Frailty (weakness)
Description
Weakness will be assessed using handgrip strength dynamometry.
Time Frame
Change from baseline to 12-weeks
Title
Frailty (fatigue)
Description
Fatigue will be assessed using the Pediatric quality of life inventory (PedsQL) Multidimensional Fatigue Scale (Range: 0 (high fatigue) - 100 (low fatigue))
Time Frame
Change from baseline to 12-weeks
Title
Frailty (energy expenditure/physical activity)
Description
Physical activity / energy expenditure will be assessed using the self-report, past-week Physical Activity Questionnaire for Adolescents (PAQ-A) (Range: 1 (inactive) - 5 (highly active))
Time Frame
Change from baseline to 12-weeks
Title
Functional Movement
Description
Functional Movement / gross motor proficiency will be assessed with the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Range: -3SD (well-below average) - +4SD (well-above average)) SD = Standard deviations
Time Frame
Change from baseline to 12-weeks
Title
Quality of Life Generic Core Scale
Description
Quality of life (QoL) will be assessed with the Pediatric Quality of Life inventory (PedsQL) Generic Core Scale (Range: 0 (low QoL) - 100 (high QoL))
Time Frame
Change from baseline to 12-weeks
Title
Quality of Life Cardiac Module
Description
Cardiac specific quality of life (QoL) will be assessed with the Pediatric Quality of Life inventory (PedsQL) Cardiac Module (Range: 0 (low QoL) - 100 (high QoL))
Time Frame
Change from baseline to 12-weeks
Title
Physical Activity Self-Efficacy
Description
Physical activity (PA) self-efficacy will be assessed using the Domain-Specific Physical Activity Efficacy Questionnaire (mean score of 0 (low PA self-efficacy) - 100 (high PA self-efficacy)
Time Frame
Change from baseline to 12-weeks
Title
Exercise session adherence (Remote Cardiac Rehab Group)
Description
Exercise session adherence will be assessed using a wrist-worn Fitbit Versa 4 activity monitor. The Fitbit Versa 4 will be used to asses exercise heart rates during the exercise sessions.
Time Frame
Baseline to 12-weeks
Title
Lifestyle Physical Activity
Description
Physical activity will be assessed using a wrist-worn Fitbit Versa 4 activity monitor. The Fitbit Versa 4 will be used to determine the volume of physical activity participation in free-living conditions.
Time Frame
Change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 12-19 years old Male or Female Diagnosed with one of three congenital heart diseases: Univentricular heart with Fontan Palliation, Tetralogy of Fallot with transannular patch, Dextro-transposition of the great arteries with arterial switch operation Clearance for exercise from their primary cardiologist Internet access in their homes Available for in-home exercise between 3-7pm on at least 3 days of the Monday-Friday work week Exclusion Criteria: Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity Participating in more than 3-months of organized athletic/exercise activity with an intensity of 5.0 or more metabolic equivalents (METs) throughout the year (not including school physical education) Height less than 132cm Pregnancy or planned surgery or procedure within the 12-week study period Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise Significant changes baseline echocardiogram or most recent clinical echocardiogram (from past clinical echocardiogram) such as decrease in ventricular and/or valvar function, new obstruction, or any new structural abnormalities Unable to meet peak exercise test criteria of respiratory exchange ratio (RER) ≥1.1 Uncontrolled or poorly controlled asthma Presence of implanted cardioverter-defibrillator Significant reliance on pacemaker (atrial or ventricular pacing ≥50%) Reliance on ventricular assist device Prescribed milrinone medication Listed for heart transplantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dara Watkins, MA
Phone
816-302-3633
Ext
73633
Email
djwatkins@cmh.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David Cloutier, MS, MBA
Phone
816-302-3636
Email
dacloutier@cmh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A White, PhD
Organizational Affiliation
Children's Mercy Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David A White, PhD
Phone
816-731-7478
Email
dawhite@cmh.edu
First Name & Middle Initial & Last Name & Degree
Dara Watkins, MA

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

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