- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07577960
Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns
The Effect of Pulmonary Rehabilitation on Respiratory Parameters in Individuals With Upper Extremity Burns
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Burn injuries may lead to physical limitations, functional loss, and respiratory problems. In individuals with upper extremity burns, pain, scar tissue, and reduced mobility of the shoulder girdle and chest wall may affect breathing mechanics and respiratory muscle performance. These changes may reduce ventilatory capacity and functional capacity during daily activities.
This randomized controlled clinical study will investigate the effects of a pulmonary rehabilitation program in adults with upper extremity burns. The study will be conducted at the Burn Center of Kartal Dr. Lütfi Kırdar City Hospital. Adults aged 18 to 65 years who had an upper extremity burn injury 3 to 12 months before enrollment and who meet the eligibility criteria will be included.
A total of 64 participants will be randomly assigned to two groups: a pulmonary rehabilitation group and a control group. The pulmonary rehabilitation group will receive respiratory muscle training combined with upper extremity aerobic exercises. The control group will receive a conventional exercise program. The intervention period will last 6 weeks.
Participants will be assessed at three time points: before the intervention, at week 3, and after the 6-week intervention. Respiratory function will be assessed using spirometry, including forced vital capacity, forced expiratory volume in one second, and maximum voluntary ventilation. Respiratory muscle activity will be evaluated using surface electromyography. Respiratory muscle thickness and diaphragm excursion will be assessed using ultrasonography. Functional capacity will be measured with the 6-minute walk test.
The study aims to determine whether pulmonary rehabilitation can improve respiratory function, respiratory muscle activity, respiratory muscle morphology, and functional capacity in individuals with upper extremity burns.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kartal
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Istanbul, Kartal, Turkey (Türkiye), 34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 65 years
- History of upper extremity burn injury 3 to 12 months before enrollment
- Clinically stable condition, including oxygen saturation greater than 92% and cardiac stability
- Ability to communicate and follow instructions, with no hearing, cognitive, or motor communication impairment
- Voluntary agreement to participate in the study and signing the informed consent form
Exclusion Criteria:
- Burns involving the lower extremity, trunk, or head and neck regions
- History of chronic pulmonary, cardiac, neurological, or musculoskeletal disease
- Dependence on mechanical ventilation or respiratory support
- Severe psychiatric disorder or cognitive impairment
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pulmonary Rehabilitation Group
Participants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises.
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Participants in the experimental group will receive a 6-week pulmonary rehabilitation program in addition to the conventional exercise program.
The pulmonary rehabilitation program will include respiratory muscle training and upper extremity aerobic exercises.
Respiratory muscle training will be performed to improve inspiratory and expiratory muscle performance.
Upper extremity aerobic exercises will be planned according to the participant's clinical status and tolerance, with the aim of improving respiratory function, chest wall mobility, exercise tolerance, and functional capacity.
Exercises will be progressed gradually during the intervention period, and participants will be monitored for dyspnea, fatigue, oxygen desaturation, and pain during the sessions.
Participants in both groups will receive a 6-week conventional exercise program as standard rehabilitation.
The program will include routine rehabilitation exercises commonly used for individuals with upper extremity burns.
Exercises will focus on maintaining and improving upper extremity range of motion, flexibility, scar-related mobility, posture, and functional use of the affected limb.
The program may include active and active-assisted range of motion exercises, stretching exercises, mobility exercises for the shoulder, elbow, wrist, and hand, and functional upper extremity activities according to the participant's clinical condition and tolerance.
|
|
Active Comparator: Conventional Exercise Group
Participants in this group will receive a 6-week conventional exercise program.
|
Participants in both groups will receive a 6-week conventional exercise program as standard rehabilitation.
The program will include routine rehabilitation exercises commonly used for individuals with upper extremity burns.
Exercises will focus on maintaining and improving upper extremity range of motion, flexibility, scar-related mobility, posture, and functional use of the affected limb.
The program may include active and active-assisted range of motion exercises, stretching exercises, mobility exercises for the shoulder, elbow, wrist, and hand, and functional upper extremity activities according to the participant's clinical condition and tolerance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Forced Vital Capacity
Time Frame: Baseline, week 3, and week 6
|
Pulmonary function will be assessed using forced vital capacity measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Forced vital capacity will be reported in liters.
|
Baseline, week 3, and week 6
|
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Change in Forced Expiratory Volume in One Second
Time Frame: Baseline, week 3, and week 6
|
Pulmonary function will be assessed using forced expiratory volume in one second measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Forced expiratory volume in one second will be reported in liters.
|
Baseline, week 3, and week 6
|
|
Change in Maximum Voluntary Ventilation
Time Frame: Baseline, week 3, and week 6
|
Pulmonary function will be assessed using maximum voluntary ventilation measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Maximum voluntary ventilation will be reported in liters per minute.
|
Baseline, week 3, and week 6
|
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Change in Diaphragm Thickness During Inspiration
Time Frame: Baseline, week 3, and week 6
|
Diaphragm thickness during inspiration will be assessed using ultrasonography to evaluate changes in diaphragm morphology over time.
Diaphragm thickness during inspiration will be reported in millimeters.
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Baseline, week 3, and week 6
|
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Change in Diaphragm Thickness During Expiration
Time Frame: Baseline, week 3, and week 6
|
Diaphragm thickness during expiration will be assessed using ultrasonography to evaluate changes in diaphragm morphology over time.
Diaphragm thickness during expiration will be reported in millimeters.
|
Baseline, week 3, and week 6
|
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Change in Diaphragm Excursion
Time Frame: Baseline, week 3, and week 6
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Diaphragm excursion will be assessed using ultrasonography to evaluate changes in diaphragm mobility over time.
Diaphragm excursion will be reported in millimeters.
|
Baseline, week 3, and week 6
|
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Change in 6-Minute Walk Distance
Time Frame: Baseline, week 3, and week 6
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Functional capacity will be assessed using the 6-minute walk test.
The distance walked during the test will be recorded in meters.
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Baseline, week 3, and week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sümeyye Akçay, Fenerbahçe University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KartalH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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