Effect of Exercises on Ventilatory Function in Adult With TOF

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)?

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 Overview

• Status: Not yet recruiting
• Conditions: Tetralogy of Fallot (TOF); Adults With Repaired Tetralogy of Fallot
• Intervention / Treatment: Other: aerobic exercise; Other: respiratory muscle training

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combined respiratory muscle training and aerobic training; participants will receive respiratory muscle training via threshold IMT device in addition to moderate intensity aerobic exercise	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 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: inspiratory muscle training; Threshold inspiratory muscle training
Active Comparator: aerobic exercise; participants will receive moderate intensity aerobic exercise	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
"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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	as an assessment of quality of live	at Baseline and after 6 weeks of training

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; aerobic exercise; inspiratory muscle training; functional capacity; congenital heart disease; tetralogy of Fallot; ventilatory functions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Tetralogy of Fallot; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Exercise; Breathing Exercises
• Other Study ID Numbers: P.T.REC/012/005997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No