Inspiratory Muscle Training in Children With Beta Thalasemia

Not Applicable

Recruiting

• Conditions: Beta Thalassemia Major
• Interventions: Behavioral: inspiratory muscle training

• Registration Number: NCT06466304
• Lead Sponsor: Ahram Canadian University

Brief Summary

respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important

Detailed Description

children patients with BTM accounted 40 children will assigned to a group of inspiratory muscle training or waiting list group. the group will contain twenty children. the group of training will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks)

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-06
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 40 beta thalassemia major children
• boys and girls

Exclusion Criteria

• respiratory diseases
• cardiac diseases renal diseases liver diseases muscle and joint disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	inspiratory muscle training	children patients with BTM accounted 20 children will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks). the session will contain six sets of inspiratory muscle training and the one set will contain five respiratory cycles

Primary Outcome Measures

Name	Time	Method
forced expiratory volume t the first second of expiration	it will be assessed after 12 weeks	it will measure pulmonary function

Secondary Outcome Measures

Name	Time	Method
maximal inspiratory pressure	it will be assessed after 12 weeks	it will measure strength of inspiratory muscles
forced vital capcity	it will be assessed after 12 weeks	it will measure pulmonary function
FEV1/FVC	it will be assessed after 12 weeks	it will measure pulmonary function
six minute walk testing	it will be assessed after 12 weeks	it will measure aerobic capacity
Pediatrics' Quality of Life Inventory (children proxy)	it will be assessed after 12 weeks	it will assess quality of life and filled by children
Pediatrics' Quality of Life Inventory (parent proxy)	it will be assessed after 12 weeks	it will assess quality of life and filled by parents of children

Trial Locations

Locations (1)

Ahram canadian university; 🇪🇬 Giza, Egypt