Congenital Heart DiseaseNCT01822769
Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
A study testing Cardiopulmonary rehabilitation in people with Congenital Heart Disease and Heart Defects, Congenital, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Heart Disease, Heart Defects, Congenital
- What is being tested?
- Cardiopulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able and willing to participate in a 12-week cardiac rehabilitation program and repeated cardiopulmonary exercise testing
- pVO2≤80% predicted (impaired aerobic capacity) on baseline exercise test
- congenital heart disease of at least moderate complexity
Who cannot join
- Cardiac intervention (cath/surg) within prior 6m
- Planned cardiac intervention (cath/surg) within 12m
- Formal cardiac rehabilitation within 24m
- Current/recent (delivery<90d prior) pregnancy, planned pregnancy within 12m
- Active heart failure, hospitalization or major change in clinical status over prior 30d
- Other recent or planned events expected to have a significant impact on exercise capacity
- Baseline oxygen saturation <92%
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. To test this hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic capacity and other physiologic markers improved fitness, as well as assessment of quality of life.
- Being tested
- Cardiopulmonary rehabilitation, Standard of care
- Keywords
- congenital heart disease, adult congenital heart disease, cardiac rehabilitation, cardiopulmonary rehabilitation, exercise, cardiopulmonary exercise testing, peak vO2, quality of life
- Medical subject headings
- Heart Defects, Congenital, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary rehabilitationOther
See Arm Description
Standard of careOther
See Arm Description
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary rehabilitation | Experimental | The subjects will attend 2 sessions each week for 12 weeks. Each session will be approximately 2 hours in duration, consisting of both exercise (aerobic and strength,~60 minutes) and education. In addition, subjects will be directed to participate in 3 weekly ~40 minute home exercise training sessions, personalized to their level of aerobic conditioning. Receives: Other: Cardiopulmonary rehabilitation |
| Standard of care | Other | Subjects randomized to standard of care will not be enrolled in a rehabilitation program, but may receive any other clinically indicated exercise training or other intervention (e.g., an exercise prescription). Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aerobic exercise capacity (peak VO2)
Measured: Baseline to 3 months (primary)
Secondary outcomes (1)
Change in quality of life measurement
Measured: Baseline to 3 months (primary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Opotowsky, Boston Children's Hospital
- Investigators
- Alexander Opotowsky, Principal investigator, Boston Children's Hospital, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822769
- Sponsor's protocol ID
- P00005391
- Status last verified
- Jan 2018
- First submitted
- 28 Mar 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01822769
- Acronym / sponsor ID
- P00005391
- Keywords
- congenital heart disease, adult congenital heart disease, cardiac rehabilitation, cardiopulmonary rehabilitation, exercise, cardiopulmonary exercise testing, peak vO2, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Apr 2013 (estimated)
- 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 hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. To test this hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic capacity and other physiologic markers improved fitness, as well as assessment of quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary rehabilitation | Experimental | Other: Cardiopulmonary rehabilitationThe subjects will attend 2 sessions each week for 12 weeks. Each session will be approximately 2 hours in duration, consisting of both exercise (aerobic and strength,~60 minutes) and education. In addition, subjects will be directed to participate in 3 weekly ~40 minute home exercise training sessions, personalized to their level of aerobic conditioning. |
| Standard of care | Other | Other: Standard of careSubjects randomized to standard of care will not be enrolled in a rehabilitation program, but may receive any other clinically indicated exercise training or other intervention (e.g., an exercise prescription). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to participate in a 12-week cardiac rehabilitation program and repeated cardiopulmonary exercise testing
- pVO2≤80% predicted (impaired aerobic capacity) on baseline exercise test
- congenital heart disease of at least moderate complexity
Key exclusion criteria (7 listed)
- Cardiac intervention (cath/surg) within prior 6m
- Planned cardiac intervention (cath/surg) within 12m
- Formal cardiac rehabilitation within 24m
- Current/recent (delivery<90d prior) pregnancy, planned pregnancy within 12m
- Active heart failure, hospitalization or major change in clinical status over prior 30d
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 |
|---|---|---|
| Cardiopulmonary rehabilitationSee Arm Description | Other | Cardiopulmonary rehabilitation |
| Standard of careSee Arm Description | Other | Standard of care |
Primary outcome
Change in aerobic exercise capacity (peak VO2)
Time frame: Baseline to 3 months (primary)
1 secondary outcome
Change in quality of life measurement
Time frame: Baseline to 3 months (primary)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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. This study is not recruiting at the moment.
Alexander Opotowsky principal investigator
Boston Children's Hospital, Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary rehabilitation in people with Congenital Heart Disease and Heart Defects, Congenital, run by Boston Children's Hospital 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 25 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aerobic exercise capacity (peak VO2) (time frame: Baseline to 3 months (primary)). 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 25 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.