Inspiratory Muscle Training in Children With Beta Thalasemia

NCT ID: NCT06466304

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-06

Study Completion Date

2024-10-01

Brief Summary

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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

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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)

Conditions

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Beta Thalassemia Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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study group

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

Group Type EXPERIMENTAL

inspiratory muscle training

Intervention Type BEHAVIORAL

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

control group

children patients with BTM accounted 20 children will receive no trianiing and will serve as control children group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 40 beta thalassemia major children
* boys and girls

Exclusion Criteria

* respiratory diseases
* cardiac diseases renal diseases liver diseases muscle and joint disease
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

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Hagar Ahmed El-Hadidy

Physical Therapy for Internal Medicine and Geriatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hagar el-hadidy, lecturer

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt

Locations

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Ahram canadian university

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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hagar el-hadidy, lecturer

Role: CONTACT

020100 745 3552

Shimaa Boundok, lectuerer

Role: CONTACT

01223749627

Facility Contacts

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hagar El-Hadidy, lecturer

Role: primary

Other Identifiers

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P.T -INT-06/2024- 544

Identifier Type: -

Identifier Source: org_study_id

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