Effect of Combined Inspiratory Muscle Training and Aerobic Exercises on Ventilatory Function in Adults With Repaired Tetralogy of Fallot
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 60
- Primary Endpoint
- "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).
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
"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
- 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)
Investigators
Omnia Ahmed Khalaf Ismail
Physical Therapist
Cairo University