Congenital Heart DiseaseNCT06519084
Home Based Program Physical Training in Congenital Heart Disease
A study testing Home based exercise training in people with Congenital Heart Disease and Functional Capacity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Previous Studies Indicate That a Substantial Proportion of the Congenital Heart Disease Patients Has Unhealthy Lifestyle Behaviors, Such as Smoking, Lack of Physical Activity, and Inadequate Dietary Patterns, Leading to the Development of Metabolic Disorders Such as Overweight/Obesity, Metabolic Syndrome, and Chronic… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Congenital Heart Disease, Functional Capacity, Body Composition
- What is being tested?
- Home based exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2020to 1 Dec 2023
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Repaired congenital heart disease of all complexities
- Age ≥ 18 years
- New York Heart Association (NYHA) Class I or II
- Able and willing to participate in a 12-week cardiac rehabilitation program
Who cannot join
- Inability to give informed consent
- Inability to participate in an exercise training program
- Severe musculoskeletal disorders.
- Patient heart failure
- Patients who perform regular physical activities.
- Patients with Univentricular Physiology,
Show all 12Show fewer
- Patients severe asthma,
- Patients with a pacemaker.
- Patients with atrial fibrillation;
- Exercise-induced arrhythmia and/or ischemia
- Cyanosis at rest
- Severe intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Physical Training in Functional Capacity, Metabolic Profile, Body Composition and Quality of Life in Patients With Congenital Heart Disease
Previous Studies Indicate That a Substantial Proportion of the Congenital Heart Disease Patients Has Unhealthy Lifestyle Behaviors, Such as Smoking, Lack of Physical Activity, and Inadequate Dietary Patterns, Leading to the Development of Metabolic Disorders Such as Overweight/Obesity, Metabolic Syndrome, and Chronic Diseases Such as Cardiovascular Disease. Another Highly Prevalent Risk Factor in These Patients is Sedentary Behavior; These Patients Are Not Encouraged to Engage in Sports and Exercise During Childhood Due to Their Cardiac Condition, Leading to a Progressive Decrease in Physical Capacity. Studies Have Shown That Congenital Heart Disease Patients Are Not Active Enough and That a Substantial Amount of Patients is Overweight.This Study is a Randomized Controlled Trial That Investigates the Effects of the Home Based Program Physical Training, in the Exercise Capacity, Quality of Life and Body Composition.
Read the detailed description
The objective of the study was to verify the effect of home physical training on improving physical capacity, body composition, quality of life, metabolic markers in patients with congenital heart disease.
- Being tested
- Home based exercise training
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based exercise trainingOther
Intervention: home based physical exercise performed 4 times a week, each session lasting 40 minutes each. Aerobic and muscular resistance exercises, using body weight and elastic bands.
The sessions were proposed through video classes, in total 12 video classes during the 12 weeks of physical training. Patients monitored their heart rate during exercise and wrote it down on spreadsheets that were monitored weekly.
| Study group | Role | What they receive |
|---|---|---|
| TG - Training group | Experimental | In this group, patients were instructed to perform home-based physical training. Training was carried out 4 times a week, each exercise session lasting 40 minutes. The session consisted of aerobic exercises and muscular resistance exercises, using body weight and elastic bands. Receives: Other: Home based exercise training |
| CG - Control group | No intervention | In this group, patients were advised to maintain their usual activities and not engage in physical training programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement exercise tolerance and functional capacity (peak VO2)
Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Peak VO2 and Predicted Peak VO2 (%). After the training program, an increase in the peak VO2(mL/kg/min) value between 10 to 15% is expected in relation to the baseline value.
Measured: Baseline to 3 months
Secondary outcomes (3)
Change in quality of life measurement
Changes in quality of life will be measure by Short Form 36 questionnaire by 8 domains: Physical functioning, Physical role functioning, body pain, general health, vitality, social functioning, emotional role functioning, mental health.
The quality of life rating for each domain is typically measured on a scale of 0 to 100, where a score close to 100 indicates a higher or higher quality of life, while a score close to 0 suggests a lower or poorer quality of life.
Measured: Baseline to 3 months
Change in body composition measurement
The body composition were assessment by the bioimpedance analyses in the baseline and After the home based training program with duration 12 weeks ou usual routine.
Measured: Baseline to 3 months
Improvement in peripheral blood flow post exercise training program
Increase forearm blood flow in mL/min/100mL
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Mar 2020
- Primary completion1 Mar 2023
- Study completion1 Dec 2023
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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519084
- Sponsor's protocol ID
- Home_based_CHD
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Training in Functional Capacity, Metabolic Profile, Body Composition and Quality of Life in Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06519084
- Acronym / sponsor ID
- Home_based_CHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 25 Jul 2024 (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.
Previous Studies Indicate That a Substantial Proportion of the Congenital Heart Disease Patients Has Unhealthy Lifestyle Behaviors, Such as Smoking, Lack of Physical Activity, and Inadequate Dietary Patterns, Leading to the Development of Metabolic Disorders Such as Overweight/Obesity, Metabolic Syndrome, and Chronic Diseases Such as Cardiovascular Disease. Another Highly Prevalent Risk Factor in These Patients is Sedentary Behavior; These Patients Are Not Encouraged to Engage in Sports and Exercise During Childhood Due to Their Cardiac Condition, Leading to a Progressive Decrease in Physical Capacity. Studies Have Shown That Congenital Heart Disease Patients Are Not Active Enough and That a Substantial Amount of Patients is Overweight.This Study is a Randomized Controlled Trial That Investigates the Effects of the Home Based Program Physical Training, in the Exercise Capacity, Quality of Life and Body Composition.
Detailed description
The objective of the study was to verify the effect of home physical training on improving physical capacity, body composition, quality of life, metabolic markers in patients with congenital heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TG - Training group | Experimental | Other: Home based exercise trainingIn this group, patients were instructed to perform home-based physical training. Training was carried out 4 times a week, each exercise session lasting 40 minutes. The session consisted of aerobic exercises and muscular resistance exercises, using body weight and elastic bands. |
| CG - Control group | No intervention | –In this group, patients were advised to maintain their usual activities and not engage in physical training programs. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Repaired congenital heart disease of all complexities
- Age ≥ 18 years
- New York Heart Association (NYHA) Class I or II
- Able and willing to participate in a 12-week cardiac rehabilitation program
Key exclusion criteria (12 listed)
- Inability to give informed consent
- Inability to participate in an exercise training program
- Severe musculoskeletal disorders.
- Patient heart failure
- Patients who perform regular physical activities.
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 |
|---|---|---|
| Home based exercise trainingIntervention: home based physical exercise performed 4 times a week, each session lasting 40 minutes each. Aerobic and muscular resistance exercises, using body weight and elastic bands. The sessions were proposed through video classes, in total 12 video classes during the 12 weeks of physical training. Patients monitored their heart rate during exercise and wrote it down on spreadsheets that were monitored weekly. | Other | TG - Training group |
Primary outcome
Improvement exercise tolerance and functional capacity (peak VO2)
Time frame: Baseline to 3 months
Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Peak VO2 and Predicted Peak VO2 (%). After the training program, an increase in the peak VO2(mL/kg/min) value between 10 to 15% is expected in relation to the baseline value.
3 secondary outcomes
Change in quality of life measurement
Time frame: Baseline to 3 months
Change in body composition measurement
Time frame: Baseline to 3 months
Improvement in peripheral blood flow post exercise training program
Time frame: Baseline to 3 months
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 Jul 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based exercise training in people with Congenital Heart Disease and Functional Capacity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 12 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 Jul 2024. 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 Brazil. 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?
Improvement exercise tolerance and functional capacity (peak VO2) (time frame: Baseline to 3 months). 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 Jul 2024.