Heart Defects, CongenitalNCT06185140
Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease.
A study testing cardiac rehabilitation program and TELEA platform in people with Heart Defects, Congenital, run by University of Salamanca.
Trial summary
Congenital heart defects (CHDs) are heart malformations that occur before birth, and they represent one of the leading causes of neonatal morbidity and mortality. they occur in approximately 1% of newborns and are associated with high morbidity and mortality rates. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- cardiac rehabilitation program and TELEA platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pediatric patients with a history of cardiac transplantation or acquired congenital heart disease who have undergone at least one interventional procedure or surgical intervention at least 6 months before the start of the program in a state of clinical stability, hemodynamic stability, and ECG stability. They should have residual hemodynamic defects of sufficient severity that potentially restrict participation, and their perception of fragility may be influenced by the social, family, school environment, or by the patient themselves.
- Children aged 6-15 years at the start of the study.
- Children with maximum predicted oxygen consumption (VO2 max) values <80%, as measured in ergospirometry 6 months before the start of the intervention program.
- Patients for whom consultation with a pediatric cardiology specialist and pediatric rehabilitation specialist has not revealed contraindications for exercise.
- Children and their legal representatives should have provided informed consent and the ability to travel to the hospital center for in-person intervention.
Who cannot join
- Patients with acute, inflammatory, or infectious health conditions that could pose a risk to them during the course of the program.
- Patients who have undergone at least one interventional procedure or surgical intervention within a period of less than 6 months before the start of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease: a Randomized Controlled Trial
Congenital heart defects (CHDs) are heart malformations that occur before birth, and they represent one of the leading causes of neonatal morbidity and mortality. they occur in approximately 1% of newborns and are associated with high morbidity and mortality rates. The etiology of these cardiac anomalies is mostly unknown. around 70-80% of cases are generated by the involvement of multiple affected genes combined with an environmental trigger that, when acting on a susceptible individual, promotes the expression of the damaged genome. maternal diseases during pregnancy or exposure to teratogenic substances are also implicated in the etiology.
- Conditions
- Heart Defects, Congenital
- Being tested
- cardiac rehabilitation program, TELEA platform
- Keywords
- Exercise, Physiotherapy
- 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.
cardiac rehabilitation programOther
Cardiac rehabilitation program
TELEA platformOther
TELEA platform
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Cardiac rehabilitation program Receives: Other: cardiac rehabilitation program |
| Control group | Active comparator | These patients will complete the program from their home through the TELEA platform that belongs to SERGAS. They go to the hospital once at the beginning of the program to learn the program with the Physiotherapist and once again after a month. The program will be carried out twice a week for their home. Patients will be monitored during physical exercise with Garmin® heart rate monitors. Patients will download heart rate and Borg scale data after each session and can establish contact through the TELEA platform with the nursing staff of the Cardiac RHB Unit at all times. Receives: Other: TELEA platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of respiratory function/spirometry
Spirometry is the study of choice in pulmonary function laboratories. The parameters it measures are the volume of air that the child breathes in or out in absolute value or related to time, and is shown in the volume/time curve. The most useful functional parameters obtained after spirometry are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), PEF and the FEV1 /FVC ratio
Measured: Baseline and immediately after the intervention
Secondary outcomes (2)
Assessment of the respiratory musculature
Volumetric Incentivator: The child will be placed in a seated position with feet on the floor and keeping the device in an upright position. The physiotherapist will ask the patient to exhale slowly and prolonged until the RV is reached and then perform a maximum inspiration through the mouthpiece ensuring lip sealing. The highest value of three procedures performed will be recorded as a reference for the intervention.
Measured: Baseline and immediately after the intervention
Functional capacity
Pediatric treadmill ergospirometry will be used. This test is able to noninvasively evaluate the functional capacity of the child and to a lesser extent for the diagnosis of ischemic events
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Jan 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies 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
- Parallel groups
- Model description
- parallel randomized controlled trial with a simply assignment (1:1)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Luis Sanchez Gonzalez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185140
- Sponsor's protocol ID
- CardiorrespiUSAL
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2023
- Last updated
- 6 Dec 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06185140
- Acronym / sponsor ID
- CardiorrespiUSAL
- Conditions
- Heart Defects, Congenital
- Keywords
- Exercise, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Dec 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.
Congenital heart defects (CHDs) are heart malformations that occur before birth, and they represent one of the leading causes of neonatal morbidity and mortality. they occur in approximately 1% of newborns and are associated with high morbidity and mortality rates. The etiology of these cardiac anomalies is mostly unknown. around 70-80% of cases are generated by the involvement of multiple affected genes combined with an environmental trigger that, when acting on a susceptible individual, promotes the expression of the damaged genome. maternal diseases during pregnancy or exposure to teratogenic substances are also implicated in the etiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel randomized controlled trial with a simply assignment (1:1)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: cardiac rehabilitation programCardiac rehabilitation program |
| Control group | Active comparator | Other: TELEA platformThese patients will complete the program from their home through the TELEA platform that belongs to SERGAS. They go to the hospital once at the beginning of the program to learn the program with the Physiotherapist and once again after a month. The program will be carried out twice a week for their home. Patients will be monitored during physical exercise with Garmin® heart rate monitors. Patients will download heart rate and Borg scale data after each session and can establish contact through the TELEA platform with the nursing staff of the Cardiac RHB Unit at all times. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pediatric patients with a history of cardiac transplantation or acquired congenital heart disease who have undergone at least one interventional procedure or surgical intervention at least 6 months before the start of the program in a state of clinical stability, hemodynamic stability, and ECG stability. They should have residual hemodynamic defects of sufficient severity that potentially restrict participation, and their perception of fragility may be influenced by the social, family, school environment, or by the patient themselves.
- Children aged 6-15 years at the start of the study.
- Children with maximum predicted oxygen consumption (VO2 max) values <80%, as measured in ergospirometry 6 months before the start of the intervention program.
- Patients for whom consultation with a pediatric cardiology specialist and pediatric rehabilitation specialist has not revealed contraindications for exercise.
- Children and their legal representatives should have provided informed consent and the ability to travel to the hospital center for in-person intervention.
Key exclusion criteria (2 listed)
- Patients with acute, inflammatory, or infectious health conditions that could pose a risk to them during the course of the program.
- Patients who have undergone at least one interventional procedure or surgical intervention within a period of less than 6 months before the start of the study.
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 |
|---|---|---|
| cardiac rehabilitation programCardiac rehabilitation program | Other | Intervention group |
| TELEA platformTELEA platform | Other | Control group |
Primary outcome
Assessment of respiratory function/spirometry
Time frame: Baseline and immediately after the intervention
Spirometry is the study of choice in pulmonary function laboratories. The parameters it measures are the volume of air that the child breathes in or out in absolute value or related to time, and is shown in the volume/time curve. The most useful functional parameters obtained after spirometry are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), PEF and the FEV1 /FVC ratio
2 secondary outcomes
Assessment of the respiratory musculature
Time frame: Baseline and immediately after the intervention
Functional capacity
Time frame: Baseline and immediately after the 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 6 Dec 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.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac rehabilitation program and TELEA platform in people with Heart Defects, Congenital, run by University of Salamanca.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Juan Luis Sánchez González, Phd (660738949, juanluissanchez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of respiratory function/spirometry (time frame: Baseline and immediately after the intervention). 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 6 Dec 2024.