Congenital Heart Disease in ChildrenRemote-CaReNCT06015191
Remote Cardiac Rehab for Adolescents With Congenital Heart Disease
A study testing Remote Cardiac Rehabilitation in people with Congenital Heart Disease in Children, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Congenital Heart Disease in Children
- What is being tested?
- Remote Cardiac Rehabilitation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Primary Cardiology clearance for exercise participation
- Internet access in their homes
Show all 9Show fewer
- Available for in-home exercise between 4-7pm on at least 3 days of the Monday-Friday work week
- English Speaking
- Achieving maximal effort on a cardiopulmonary exercise test, defined as RER ≥1.1 and/or in the judgement of the supervising exercise physiologist, a maximal effort was achieved but exercise capacity is limited by musculoskeletal deconditioning.
Who cannot join
- Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity
- Participating in > 15 MET-hours per week (mean weekly average over the past 12-months) of organized athletic/exercise activity (not including school physical education class).
- Height less than 132cm
- Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) 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
Show all 14Show fewer
- 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
- Uncontrolled or poorly controlled asthma
- Presence of implanted cardioverter-defibrillator
- Pacemaker with rate-responsive function initiated
- Reliance on ventricular assist device
- Prescribed milrinone medication
- Listed for heart transplantation
- Active engagement in hormone replacement for gender transition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Kansas City
Kansas City, Missouri, 64108
David A White, PhD, 8167317478, dawhite@cmh.edu
Dara Watkins, MA
About this study
Official title: Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease
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.
Read the 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.
- Conditions
- Congenital Heart Disease in Children
- Being tested
- Remote Cardiac Rehabilitation, Active Control
- Keywords
- Exercise, Cardiac Rehabilitation, Physical Activity, Telehealth
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Cardiac RehabilitationBehavioural
Also called RCR
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.
Active ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote Cardiac Rehabilitation | Experimental | 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. Receives: Behavioral: Remote Cardiac Rehabilitation |
| Active Control | Active comparator | 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. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 12-weeks
Secondary outcomes (13)
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.
Measured: Change from baseline to 12-weeks
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.
Measured: Change from baseline to 12-weeks
Lean Body Mass
Body composition will be assessed using whole-body dual energy X-ray absorptiometry (DXA)
Measured: Change from baseline to 12-weeks
Frailty (slowness)
Slowness will be assessed using a 6-minute walk test
Measured: Change from baseline to 12-weeks
Frailty (weakness)
Weakness will be assessed using handgrip strength dynamometry.
Measured: Change from baseline to 12-weeks
Frailty (fatigue)
Fatigue will be assessed using the Pediatric quality of life inventory (PedsQL) Multidimensional Fatigue Scale (Range: 0 (high fatigue) - 100 (low fatigue))
Measured: Change from baseline to 12-weeks
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))
Measured: Change from baseline to 12-weeks
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
Measured: Change from baseline to 12-weeks
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))
Measured: Change from baseline to 12-weeks
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))
Measured: Change from baseline to 12-weeks
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)
Measured: Change from baseline to 12-weeks
Exercise session adherence (Remote Cardiac Rehab Group)
Exercise session adherence will be assessed using a wrist-worn Fitbit Versa 4 or Garmin Vivoactive 5 activity monitor. The Fitbit Versa 4 or Garmin Vivoactive 5 will be used to asses exercise heart rates during the exercise sessions.
Measured: Baseline to 12-weeks
Lifestyle Physical Activity
Physical activity will be assessed using a wrist-worn Fitbit Versa 4 or Garmin Vivoactive 5 activity monitor. The Fitbit Versa 4 or Garmin Vivoactive 5 will be used to determine the volume of physical activity participation in free-living conditions.
Measured: Change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start31 Aug 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas, Children's Hospital of Philadelphia, University of North Carolina, Chapel Hill, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David White, Children's Mercy Hospital Kansas City
- Investigators
- David A White, PhD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015191
- Sponsor's protocol ID
- STUDY00000990
- Other IDs
- K23HL159325-01A1
- Acronym
- Remote-CaRe
- Status last verified
- Apr 2026
- First submitted
- 5 May 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06015191
- Acronym / sponsor ID
- Remote-CaRe / STUDY00000990
- Conditions
- Congenital Heart Disease in Children
- Keywords
- Exercise, Cardiac Rehabilitation, Physical Activity, Telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Kansas, Children's Hospital of Philadelphia, University of North Carolina, Chapel Hill, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Remote Cardiac Rehabilitation | Experimental | Behavioral: Remote Cardiac RehabilitationFollowing 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. |
| Active Control | Active comparator | Behavioral: Active ControlParticipants 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
- Primary Cardiology clearance for exercise participation
Key exclusion criteria (14 listed)
- Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity
- Participating in > 15 MET-hours per week (mean weekly average over the past 12-months) of organized athletic/exercise activity (not including school physical education class).
- Height less than 132cm
- Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Cardiac RehabilitationAlso: RCRParticipants 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. | Behavioural | Remote Cardiac Rehabilitation |
| Active ControlParticipants 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. | Behavioural | Active Control |
Primary outcome
Peak Cardiorespiratory Fitness
Time frame: Change from baseline to 12-weeks
Cardiorespiratory fitness will be assessed using a peak cardiopulmonary exercise stress test (VO2peak) on a cycle ergometer using a ramping cycle protocol.
13 secondary outcomes
Echocardiogram with global longitudinal strain (Fontan)
Time frame: Change from baseline to 12-weeks
Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)
Time frame: Change from baseline to 12-weeks
Lean Body Mass
Time frame: Change from baseline to 12-weeks
Frailty (slowness)
Time frame: Change from baseline to 12-weeks
Frailty (weakness)
Time frame: Change from baseline to 12-weeks
Frailty (fatigue)
Time frame: Change from baseline to 12-weeks
Frailty (energy expenditure/physical activity)
Time frame: Change from baseline to 12-weeks
Functional Movement
Time frame: Change from baseline to 12-weeks
Quality of Life Generic Core Scale
Time frame: Change from baseline to 12-weeks
Quality of Life Cardiac Module
Time frame: Change from baseline to 12-weeks
Physical Activity Self-Efficacy
Time frame: Change from baseline to 12-weeks
Exercise session adherence (Remote Cardiac Rehab Group)
Time frame: Baseline to 12-weeks
Lifestyle Physical Activity
Time frame: Change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Video describing the Remote CaRe clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David A White, PhD principal investigator
Children's Mercy Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Cardiac Rehabilitation in people with Congenital Heart Disease in Children, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline Donnelli, BS (816-764-5605, Remotecare@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Cardiorespiratory Fitness (time frame: Change from baseline to 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.