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Not yet recruiting NCT07326228

Effect of Exercises on Ventilatory Function in Adult With TOF

No phase Interventional Tetralogy of Fallot (TOF) Adults With Repaired Tetralogy of Fallot

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: aerobic exercise, respiratory muscle training.
Who it may be relevant to
Registry conditions: Tetralogy of Fallot (TOF), Adults With Repaired Tetralogy of Fallot. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Combined Inspiratory Muscle Training and Aerobic Exercises on Ventilatory Function in Adults With Repaired Tetralogy of Fallot

Overview

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

Interventions

  • Other aerobic exercise
    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
  • Other respiratory 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 t

Primary outcome measures

  • "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]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Hemodynamic instability
  • Mouth burn, injury, or deformities
  • Implanted pacemaker

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07326228 · P.T.REC/012/005997

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗