Effect of Exercises on Ventilatory Function in Adult With TOF

NCT ID: NCT07326228

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

combined respiratory muscle training and aerobic training

participants will receive respiratory muscle training via threshold IMT device in addition to moderate intensity aerobic exercise

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: 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

Intervention Type: 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.

aerobic exercise

participants will receive moderate intensity aerobic exercise

Group Type: ACTIVE_COMPARATOR

aerobic exercise

Intervention Type: 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

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Threshold inspiratory muscle training; inspiratory muscle 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Omnia Ahmed Khalaf Ismail

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P.T.REC/012/005997

Identifier Type: -

Identifier Source: org_study_id