Tetralogy of Fallot (TOF)NCT07326228
Effect of Exercises on Ventilatory Function in Adult With TOF
A study testing aerobic exercise and respiratory muscle training in people with Tetralogy of Fallot (TOF) and Adults With Repaired Tetralogy of Fallot, run by Cairo University.
Trial summary
The goal of this clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF). It will also learn if exercises work to raise functional capacity and Quality of life (QoL) . Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Tetralogy of Fallot (TOF), Adults With Repaired Tetralogy of Fallot
- What is being tested?
- aerobic exercise and respiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Jan 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with TOF.
- Have surgical correction of the abnormality.
- Class II-III according to New York Heart Association (NYHA)
- Ejection fracture > 40
- Vitally stable during the study period
Who cannot join
- Resent cardiopulmonary surgery or intervention "less than 6 months"
- Presence of pulmonary disease which is not a complication of TOF (eg:
- bronchial asthma, lung fibrosis…..)
- Neuromuscular or musculoskeletal disease and severe scoliosis affecting pulmonary function or physical exercise.
- Mental or physical limitations
- active infection or systemic illness.
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- Hemodynamic instability
- Mouth burn, injury, or deformities
- Implanted pacemaker
About this study
Official title: Effect of Combined Inspiratory Muscle Training and Aerobic Exercises on Ventilatory Function in Adults With Repaired Tetralogy of Fallot
The goal of this clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF). It will also learn if exercises work to raise functional capacity and Quality of life (QoL) . The main questions it aims to answer is:
- Dose combined inspiratory muscle training and aerobic exercise (study group) improve ventilatory function in adults with repaired (TOF) more than aerobic exercise only (control group)?
- Can combine inspiratory muscle training and aerobic exercise (study group) raise functional capacity and (QoL) in adults with repaired (TOF) more than aerobic exercise only (control group)?
Read more
Researchers will compare between combination of inspiratory muscle training and aerobic exercise on one group and the aerobic exercise only on other group, on ventilatory function, functional capacity and (QoL) on adults with repaired TOF.
Participants will:
On study group , participants will perform respiratory muscle training in addition to moderate intensity aerobic exercise for 6 weeks. 3 times/week
On controlled group , participants will perform moderate intensity aerobic exercise for 6 weeks. 3 times/week.
all participants will test ventilatory function , functional capacity and will answer a survey questions about their quality of life before and after training
- Being tested
- aerobic exercise, respiratory muscle training
- Keywords
- congenital heart disease, tetralogy of Fallot, inspiratory muscle training, aerobic exercise, ventilatory functions, functional capacity, Quality of life
- Medical subject headings
- Tetralogy of Fallot, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
moderate intensity aerobic exercises on a treadmill:
- Symptom-limited treadmill exercise training will be carried out at baseline for each participant following the modified Bruce protocol to estimate each participant's peak heart rate.
- the target heart rate during training will be 50-60 % of each participant's heart rate reserve (moderate intensity exercise)
- each session will have 5-10 min warm up, at least 20 min of moderate intensity aerobic exercise , and 5-10 min of cool down
respiratory muscle trainingOther
Also called Threshold inspiratory muscle training, inspiratory muscle training
respiratory muscle training via threshold inspiratory muscle trainer (IMT) device:
- maximum inspiratory effort will be detected for each participant as the maximum resistance at which the participant can efficiently achieve 10 breathing cycles, via (Threshold IMT device)
- the training will be initiated with a low-intensity load (20-30%) of the participant's maximum inspiratory effort via (Threshold IMT device). Then, the intensity will increase gradually by 5% according to the participant's tolerance weekly until achieving 50% of maximum inspiratory effort.
- the session will be formed of six sets, each set consisting of five deep breaths against the (Threshold IMT device), with a short interval of 1-2-minute rest between sets.
| Study group | Role | What they receive |
|---|---|---|
| combined respiratory muscle training and aerobic training | Experimental | participants will receive respiratory muscle training via threshold IMT device in addition to moderate intensity aerobic exercise Receives: Other: aerobic exercise; Other: respiratory muscle training |
| aerobic exercise | Active comparator | participants will receive moderate intensity aerobic exercise Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Change from Baseline in Ventilatory function : Forced vital capacity (FVC) , Forced expiratory volume in 1 second (FEV1), expiratory vital capacity (EVC) and inspiratory vital capacity (IVC).
Measured: At Baseline and after 6 weeks of training
Secondary outcomes (2)
Change from Baseline in Six-minute walk test (6MWT)
Measured: At Baseline and after 6 weeks of training
changes from baseline in 36-Item Short Form Health Survey (SF-36)
as an assessment of quality of live
Measured: at Baseline and after 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of Fallot (TOF)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Ahmed Khalaf Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326228
- Sponsor's protocol ID
- P.T.REC/012/005997
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Inspiratory Muscle Training and Aerobic Exercises on Ventilatory Function in Adults With Repaired Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT07326228
- Acronym / sponsor ID
- P.T.REC/012/005997
- Keywords
- congenital heart disease, tetralogy of Fallot, inspiratory muscle training, aerobic exercise, ventilatory functions, functional capacity, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 Jan 2026 (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 clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF). It will also learn if exercises work to raise functional capacity and Quality of life (QoL) . The main questions it aims to answer is:
- Dose combined inspiratory muscle training and aerobic exercise (study group) improve ventilatory function in adults with repaired (TOF) more than aerobic exercise only (control group)?
- Can combine inspiratory muscle training and aerobic exercise (study group) raise functional capacity and (QoL) in adults with repaired (TOF) more than aerobic exercise only (control group)?
Researchers will compare between combination of inspiratory muscle training and aerobic exercise on one group and the aerobic exercise only on other group, on ventilatory function, functional capacity and (QoL) on adults with repaired TOF.
Participants will:
On study group , participants will perform respiratory muscle training in addition to moderate intensity aerobic exercise for 6 weeks. 3 times/week
On controlled group , participants will perform moderate intensity aerobic exercise for 6 weeks. 3 times/week.
all participants will test ventilatory function , functional capacity and will answer a survey questions about their quality of life before and after training
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined respiratory muscle training and aerobic training | Experimental | Other: aerobic exercise, Other: respiratory muscle trainingparticipants will receive respiratory muscle training via threshold IMT device in addition to moderate intensity aerobic exercise |
| aerobic exercise | Active comparator | Other: aerobic exerciseparticipants will receive moderate intensity aerobic exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with TOF.
- Have surgical correction of the abnormality.
- Class II-III according to New York Heart Association (NYHA)
- Ejection fracture > 40
- Vitally stable during the study period
Key exclusion criteria (9 listed)
- Resent cardiopulmonary surgery or intervention "less than 6 months"
- Presence of pulmonary disease which is not a complication of TOF (eg:
- bronchial asthma, lung fibrosis…..)
- Neuromuscular or musculoskeletal disease and severe scoliosis affecting pulmonary function or physical exercise.
- Mental or physical limitations
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 |
|---|---|---|
| aerobic exercisemoderate intensity aerobic exercises on a treadmill: * Symptom-limited treadmill exercise training will be carried out at baseline for each participant following the modified Bruce protocol to estimate each participant's peak heart rate. * the target heart rate during training will be 50-60 % of each participant's heart rate reserve (moderate intensity exercise) * each session will have 5-10 min warm up, at least 20 min of moderate intensity aerobic exercise , and 5-10 min of cool down | Other | aerobic exercise, combined respiratory muscle training and aerobic training |
| respiratory muscle trainingAlso: Threshold inspiratory muscle training, inspiratory muscle trainingrespiratory muscle training via threshold inspiratory muscle trainer (IMT) device: * maximum inspiratory effort will be detected for each participant as the maximum resistance at which the participant can efficiently achieve 10 breathing cycles, via (Threshold IMT device) * the training will be initiated with a low-intensity load (20-30%) of the participant's maximum inspiratory effort via (Threshold IMT device). Then, the intensity will increase gradually by 5% according to the participant's tolerance weekly until achieving 50% of maximum inspiratory effort. * the session will be formed of six sets, each set consisting of five deep breaths against the (Threshold IMT device), with a short interval of 1-2-minute rest between sets. | Other | combined respiratory muscle training and aerobic training |
Primary outcome
"Change from Baseline in Ventilatory function : Forced vital capacity (FVC) , Forced expiratory volume in 1 second (FEV1), expiratory vital capacity (EVC) and inspiratory vital capacity (IVC).
Time frame: At Baseline and after 6 weeks of training
2 secondary outcomes
Change from Baseline in Six-minute walk test (6MWT)
Time frame: At Baseline and after 6 weeks of training
changes from baseline in 36-Item Short Form Health Survey (SF-36)
Time frame: at Baseline and after 6 weeks of training
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 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Tetralogy of Fallot (TOF)
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Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
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ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and respiratory muscle training in people with Tetralogy of Fallot (TOF) and Adults With Repaired Tetralogy of Fallot, run by Cairo University.
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 9 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 8 Jan 2026. 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?
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 from Baseline in Ventilatory function : Forced vital capacity (FVC) , Forced expiratory volume in 1 second (FEV1), expiratory vital capacity (EVC) and inspiratory vital capacity (IVC). (time frame: At Baseline and after 6 weeks of training). 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 8 Jan 2026.