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NCT Number: NCT07326228

Effect of Exercises on Ventilatory Function in Adult With TOF

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

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Key information

Conditions

Tetralogy of Fallot (TOF) Adults With Repaired Tetralogy of Fallot Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Tetralogy of Fallot

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

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 training

Other

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.

Other names: Threshold inspiratory muscle training, inspiratory muscle training

Primary outcomes

  1. "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 outcomes

  1. Change from Baseline in Six-minute walk test (6MWT)

    Time frame: At Baseline and after 6 weeks of training

  2. changes from baseline in 36-Item Short Form Health Survey (SF-36)

    Time frame: at Baseline and after 6 weeks of training

    as an assessment of quality of live

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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