Inspiratory Muscle Training in Children With Beta Thalasemia
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2024
CompletedFirst Submitted
Initial submission to the registry
June 14, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJune 20, 2024
June 1, 2024
4 months
June 14, 2024
June 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
forced expiratory volume t the first second of expiration
it will measure pulmonary function
it will be assessed after 12 weeks
Secondary Outcomes (6)
forced vital capcity
it will be assessed after 12 weeks
FEV1/FVC
it will be assessed after 12 weeks
maximal inspiratory pressure
it will be assessed after 12 weeks
six minute walk testing
it will be assessed after 12 weeks
Pediatrics' Quality of Life Inventory (children proxy)
it will be assessed after 12 weeks
- +1 more secondary outcomes
Study Arms (2)
study group
EXPERIMENTALchildren 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
control group
NO INTERVENTIONchildren patients with BTM accounted 20 children will receive no trianiing and will serve as control children group
Interventions
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
Eligibility Criteria
You may qualify if:
- beta thalassemia major children
- boys and girls
You may not qualify if:
- respiratory diseases
- cardiac diseases renal diseases liver diseases muscle and joint disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahram canadian university
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
hagar el-hadidy, lecturer
Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical Therapy for Internal Medicine and Geriatrics
Study Record Dates
First Submitted
June 14, 2024
First Posted
June 20, 2024
Study Start
June 6, 2024
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
June 20, 2024
Record last verified: 2024-06