Inspiratory Muscle Training in Children With Beta Thalasemia

Beta Thalassemia Major Clinical Trial

Official title:

Inspiratory Muscle Training in Children With Beta Thalasemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466304
• Other study ID #: P.T -INT-06/2024- 544
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2024
• Source: Ahram Canadian University
• Contact: hagar el-hadidy, lecturer
• Phone: 020100 745 3552
• Email: hagarhadidy2016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• 40 beta thalassemia major children

• boys and girls

Exclusion Criteria:

• respiratory diseases

• cardiac diseases renal diseases liver diseases muscle and joint disease

Related Conditions & MeSH terms

• Beta Thalassemia Major
• beta-Thalassemia
• Thalassemia

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Egypt	Ahram canadian university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	forced expiratory volume t the first second of expiration	it will measure pulmonary function	it will be assessed after 12 weeks
Secondary	forced vital capcity	it will measure pulmonary function	it will be assessed after 12 weeks
Secondary	FEV1/FVC	it will measure pulmonary function	it will be assessed after 12 weeks
Secondary	maximal inspiratory pressure	it will measure strength of inspiratory muscles	it will be assessed after 12 weeks
Secondary	six minute walk testing	it will measure aerobic capacity	it will be assessed after 12 weeks
Secondary	Pediatrics' Quality of Life Inventory (children proxy)	it will assess quality of life and filled by children	it will be assessed after 12 weeks
Secondary	Pediatrics' Quality of Life Inventory (parent proxy)	it will assess quality of life and filled by parents of children	it will be assessed after 12 weeks