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CompletedNCT06315712BurnsUpdated Mar 18, 2024

Inspiratory Muscle Training in Burned Adults

An interventional study of inspiratory exercise and Pulmonary rehabilitation in Burn Injuries, sponsored by Qassim University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Qassim University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Jan 2021, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
20 Years to 49 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Burn Injuries

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03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 52 is above the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Qassim University is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Respiratory muscle training group

    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 exercise · Other: Pulmonary rehabilitation

  • Experimental
    Pulmonary rehabilitation group

    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

  • Otherinspiratory 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

    Also known as: inspiratory muscle training

  • OtherPulmonary rehabilitation

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

    Also known as: Resistance exercise

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What researchers measure

Primary outcomes

  1. maximal inspiratory pressure

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

    Time frame: At the beginning of intervention

  2. maximal inspiratory pressure

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

    Time frame: After 8 weeks of intervention

  3. maximal expiratory pressure

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

    Time frame: At the beginning of intervention

  4. maximal expiratory pressure

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

    Time frame: After 8 weeks of intervention

  5. Forced expiratory volume in 1 second

    performed using a spirometer

    Time frame: At the beginning of intervention

  6. Forced expiratory volume in 1 second

    performed using a spirometer

    Time frame: After 8 weeks of intervention

  7. forced vital capacity

    performed using a spirometer

    Time frame: At the beginning of intervention

  8. forced vital capacity

    performed using a spirometer

    Time frame: After 8 weeks of intervention

  9. Forced expiratory volume in 1 second/ forced vital capacity ratio

    performed using a spirometer

    Time frame: At the beginning of intervention

  10. Forced expiratory volume in 1 second/ forced vital capacity ratio

    performed using a spirometer

    Time frame: After 8 weeks of intervention

Secondary outcomes

  1. Functional exercise capacity

    assessed using the six-minute walk test

    Time frame: At the beginning of intervention

  2. Functional exercise capacity

    assessed using the six-minute walk test

    Time frame: After 8 weeks of intervention

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Study locations

1 site
  • Faculty of Physical Therapy, Cairo University
    Giza, Dokki 11432, Egypt
08

References and documents

Publications

  • 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. PubMed 21530086 ↗
  • 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. PubMed 31999499 ↗
  • 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. Erratum In: Burns. 2020 Aug;46(5):1240-1241. doi: 10.1016/j.burns.2020.02.012. PubMed 29017743 ↗

Individual participant data

Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06315712
Lead sponsor
Qassim University
Collaborators
Cairo University
Responsible party
Maged Basha (Assistant Professor, College of Applied Medical Sciences, Qassim University, Qassim University) — Principal investigator
First posted
Mar 18, 2024
Start date
Jan 15, 2021
Primary completion
Jun 16, 2022
Completion
Sep 11, 2023
Last update
Mar 18, 2024

Study contacts

FatmaAlzahraa Kamel, PhD
principal investigator · Cairo University
Maged Basha, PhD
study chair · Qassim University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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