An interventional study of Pulmonary Rehabilitation Program and Conventional Exercise Program in Burn Injury and Pulmonary Rehabilitation, sponsored by Fenerbahce University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Fenerbahce University · Not applicable, Interventional, and Treatment
This study will evaluate the effects of a pulmonary rehabilitation program on breathing function, respiratory muscle activity, respiratory muscle thickness, and functional capacity in adults with upper extremity burns. Participants will be randomly assigned to either a pulmonary rehabilitation group or a control group. The pulmonary rehabilitation group will receive respiratory muscle training together with upper extremity aerobic exercises, while the control group will receive a conventional exercise program. Assessments will be performed before the intervention, at week 3, and after the 6-week intervention period. The results may help improve rehabilitation approaches for people with upper extremity burns.
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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 64 is above the median of 40 across 663 interventional studies indexed under Burns.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises.
Other: Pulmonary Rehabilitation Program · Other: Conventional Exercise Program
Participants in this group will receive a 6-week conventional exercise program.
Other: Conventional Exercise Program
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.
Change in Forced Vital Capacity
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.
Time frame: Baseline, week 3, and week 6
Change in Forced Expiratory Volume in One Second
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.
Time frame: Baseline, week 3, and week 6
Change in Maximum Voluntary Ventilation
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.
Time frame: Baseline, week 3, and week 6
Change in Diaphragm Thickness During Inspiration
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.
Time frame: Baseline, week 3, and week 6
Change in Diaphragm Thickness During Expiration
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.
Time frame: Baseline, week 3, and week 6
Change in Diaphragm Excursion
Diaphragm excursion will be assessed using ultrasonography to evaluate changes in diaphragm mobility over time. Diaphragm excursion will be reported in millimeters.
Time frame: Baseline, week 3, and week 6
Change in 6-Minute Walk Distance
Functional capacity will be assessed using the 6-minute walk test. The distance walked during the test will be recorded in meters.
Time frame: Baseline, week 3, and week 6
Plan to share: No — Individual participant data will not be shared because of participant privacy and confidentiality considerations. The data collected in this study will be used only for the purposes described in the approved study protocol and informed consent form. De-identified aggregate results may be presented in scientific meetings or published in scientific journals.
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