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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06315712
Other study ID # 004201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2021
Est. completion date September 11, 2023

Study information

Verified date March 2024
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study outlines burn injury impact, emphasizes need for long-term rehabilitation. Study assesses inspiratory muscle training efficacy in improving respiratory strength, lung function, and exercise capacity in adult burn patients.


Description:

The study aimed to evaluate the effectiveness of adding inspiratory muscle training to pulmonary rehabilitation in adult burn patients. Fifty-two participants were randomly assigned to either inspiratory muscle training plus pulmonary rehabilitation or pulmonary rehabilitation alone for 8 weeks. Inspiratory muscle training consisted of using a Powerbreathe device for inspiratory muscle strengthening.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date September 11, 2023
Est. primary completion date June 16, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 49 Years
Eligibility Inclusion Criteria: - Burn-injured adults aged 20-49. - Admitted to the clinic after acute treatment. - Recovering from burns affecting at least 20% total body surface area. - Partial or full-thickness burns. Exclusion Criteria: - Smokers. - had open or unhealed wounds. - had any known neurological deficit. - neuromuscular diseases. - musculoskeletal deformities. - pulmonary diseases. - severe cardiac problems. - inability to participate in regular exercise.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
inspiratory exercise
The training consisted of 6 sets of 30 breaths per day, divided into 2 sessions per day. A one-minute rest interval between each set. Training was prescribed 5 days a week for 8 weeks
Pulmonary rehabilitation
Four resistive exercises, aerobic exercise, and deep breathing exercises, five sessions per week for 8 weeks

Locations

Country Name City State
Egypt Faculty of Physical Therapy, Cairo University Giza Dokki

Sponsors (2)

Lead Sponsor Collaborator
Qassim University Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Gittings PM, Grisbrook TL, Edgar DW, Wood FM, Wand BM, O'Connell NE. Resistance training for rehabilitation after burn injury: A systematic literature review & meta-analysis. Burns. 2018 Jun;44(4):731-751. doi: 10.1016/j.burns.2017.08.009. Epub 2017 Oct 7 — View Citation

Ozkal O, Topuz S, Karahan S, Erdem MM, Konan A, Yasti AC. Clinical predictors of pulmonary functions, respiratory/peripheral muscle strength and exercise capacity at discharge in adults with burn injury. Disabil Rehabil. 2021 Oct;43(20):2875-2881. doi: 10.1080/09638288.2020.1720320. Epub 2020 Jan 30. — View Citation

Willis CE, Grisbrook TL, Elliott CM, Wood FM, Wallman KE, Reid SL. Pulmonary function, exercise capacity and physical activity participation in adults following burn. Burns. 2011 Dec;37(8):1326-33. doi: 10.1016/j.burns.2011.03.016. Epub 2011 May 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary maximal inspiratory pressure performed using an electronic respiratory pressure meter, measures inspiratory muscle strength At the beginning of intervention
Primary maximal inspiratory pressure performed using an electronic respiratory pressure meter, measures inspiratory muscle strength After 8 weeks of intervention
Primary maximal expiratory pressure performed using an electronic respiratory pressure meter, assesses expiratory muscle strength. At the beginning of intervention
Primary maximal expiratory pressure performed using an electronic respiratory pressure meter, assesses expiratory muscle strength. After 8 weeks of intervention
Primary Forced expiratory volume in 1 second performed using a spirometer At the beginning of intervention
Primary Forced expiratory volume in 1 second performed using a spirometer After 8 weeks of intervention
Primary forced vital capacity performed using a spirometer At the beginning of intervention
Primary forced vital capacity performed using a spirometer After 8 weeks of intervention
Primary Forced expiratory volume in 1 second/ forced vital capacity ratio performed using a spirometer At the beginning of intervention
Primary Forced expiratory volume in 1 second/ forced vital capacity ratio performed using a spirometer After 8 weeks of intervention
Secondary Functional exercise capacity assessed using the six-minute walk test At the beginning of intervention
Secondary Functional exercise capacity assessed using the six-minute walk test After 8 weeks of intervention
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