Effect of Exercises on Ventilatory Function in Adult With TOF

Cairo University (CU)

Status: Not yet enrolling

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

Treatments: Other: aerobic exercise; Other: respiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT07326228

P.T.REC/012/005997

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

combined respiratory muscle training and aerobic training

Experimental group

Description:

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

Treatment:

Other: respiratory muscle training

Other: aerobic exercise

aerobic exercise

Active Comparator group

Description:

participants will receive moderate intensity aerobic exercise

Treatment:

Other: aerobic exercise