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Inspiratory Muscle Training in Children With Beta Thalasemia

Inspiratory Muscle Training in Children With Beta Thalasemia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06466304
Enrollment
40
Registered
2024-06-20
Start date
2024-06-06
Completion date
2024-10-01
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta Thalassemia Major

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)

Interventions

BEHAVIORALinspiratory 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

Sponsors

Ahram Canadian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 40 beta thalassemia major children * boys and girls

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
forced expiratory volume t the first second of expirationit will be assessed after 12 weeksit will measure pulmonary function

Secondary

MeasureTime frameDescription
six minute walk testingit will be assessed after 12 weeksit will measure aerobic capacity
forced vital capcityit will be assessed after 12 weeksit will measure pulmonary function
maximal inspiratory pressureit will be assessed after 12 weeksit will measure strength of inspiratory muscles
Pediatrics' Quality of Life Inventory (children proxy)it will be assessed after 12 weeksit will assess quality of life and filled by children
Pediatrics' Quality of Life Inventory (parent proxy)it will be assessed after 12 weeksit will assess quality of life and filled by parents of children
FEV1/FVCit will be assessed after 12 weeksit will measure pulmonary function

Countries

Egypt

Contacts

Primary Contacthagar el-hadidy, lecturer
hagarhadidy2016@gmail.com020100 745 3552
Backup ContactShimaa Boundok, lectuerer
dr.shaimaa.bondok@dtu.edu.eg01223749627

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026