NCT06315712

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 12, 2024

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (10)

  • maximal inspiratory pressure

    performed using an electronic respiratory pressure meter, measures inspiratory muscle strength

    At the beginning of intervention

  • maximal inspiratory pressure

    performed using an electronic respiratory pressure meter, measures inspiratory muscle strength

    After 8 weeks of intervention

  • maximal expiratory pressure

    performed using an electronic respiratory pressure meter, assesses expiratory muscle strength.

    At the beginning of intervention

  • maximal expiratory pressure

    performed using an electronic respiratory pressure meter, assesses expiratory muscle strength.

    After 8 weeks of intervention

  • Forced expiratory volume in 1 second

    performed using a spirometer

    At the beginning of intervention

  • Forced expiratory volume in 1 second

    performed using a spirometer

    After 8 weeks of intervention

  • forced vital capacity

    performed using a spirometer

    At the beginning of intervention

  • forced vital capacity

    performed using a spirometer

    After 8 weeks of intervention

  • Forced expiratory volume in 1 second/ forced vital capacity ratio

    performed using a spirometer

    At the beginning of intervention

  • Forced expiratory volume in 1 second/ forced vital capacity ratio

    performed using a spirometer

    After 8 weeks of intervention

Secondary Outcomes (2)

  • Functional exercise capacity

    At the beginning of intervention

  • Functional exercise capacity

    After 8 weeks of intervention

Study Arms (2)

Respiratory muscle training group

EXPERIMENTAL

Received inspiratory muscle training plus pulmonary rehabilitation program. Powerbreathe device was used for the exercise of the inspiratory muscle strength. Strengthening the inspiratory muscles with the Powerbreathe is similar to weightlifting to strengthen other muscles in the body.

Other: inspiratory exerciseOther: Pulmonary rehabilitation

Pulmonary rehabilitation group

EXPERIMENTAL

Received pulmonary rehabilitation program for five sessions per week for 8 weeks. Four resistive exercises, aerobic exercise, and deep breathing exercises, aerobic conditioning exercises on the treadmill. All exercises were performed using variable resistance machines.

Other: Pulmonary rehabilitation

Interventions

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

Also known as: inspiratory muscle training
Respiratory muscle training group

Four resistive exercises, aerobic exercise, and deep breathing exercises, five sessions per week for 8 weeks

Also known as: Resistance exercise
Pulmonary rehabilitation groupRespiratory muscle training group

Eligibility Criteria

Age20 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Dokki, 11432, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 21530086BACKGROUND
  • 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.

    PMID: 31999499BACKGROUND
  • 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.

MeSH Terms

Conditions

Burns

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • FatmaAlzahraa Kamel, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Maged Basha, PhD

    Qassim University

    STUDY CHAIR

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
Assistant Professor, College of Applied Medical Sciences, Qassim University

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 18, 2024

Study Start

January 15, 2021

Primary Completion

June 16, 2022

Study Completion

September 11, 2023

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations