Effect of Exercises on Ventilatory Function in Adult With TOF

NCT07326228 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005997
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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) . 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

Conditions

Tetralogy of Fallot (TOF); Adults With Repaired Tetralogy of Fallot

Keywords

congenital heart disease; tetralogy of Fallot; inspiratory muscle training; aerobic exercise; ventilatory functions; functional capacity; Quality of life

Outcome Measures

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).

  At Baseline and after 6 weeks of training

Secondary Outcomes (2)

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

  At Baseline and after 6 weeks of training

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

  at Baseline and after 6 weeks of training

Study Arms (2)

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

Other: aerobic exercise; Other: respiratory muscle training

aerobic exercise

ACTIVE COMPARATOR

participants will receive moderate intensity aerobic exercise

Other: aerobic exercise

Interventions

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

aerobic exercise; combined respiratory muscle training and aerobic training

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.

Also known as: Threshold inspiratory muscle training, inspiratory muscle training

combined respiratory muscle training and aerobic training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tetralogy of Fallot; Heart Defects, Congenital

Interventions

Exercise; Breathing Exercises

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12