Burn InjuryNCT07577960
Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns
A study testing Pulmonary Rehabilitation Program and Conventional Exercise Program in people with Burn Injury and Pulmonary Rehabilitation, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn Injury, Pulmonary Rehabilitation
- What is being tested?
- Pulmonary Rehabilitation Program and Conventional Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
Istanbul, Kartal, 34865
About this study
Official title: The Effect of Pulmonary Rehabilitation on Respiratory Parameters in Individuals With Upper Extremity Burns
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.
Read the 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.
- Conditions
- Burn Injury, Pulmonary Rehabilitation
- Being tested
- Pulmonary Rehabilitation Program, Conventional Exercise Program
- Keywords
- Upper Extremity Burns, Pulmonary Rehabilitation, Respiratory Function
- Medical subject headings
- Burns, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation ProgramOther
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.
Conventional Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation Group | Experimental | Participants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises. Receives: Other: Pulmonary Rehabilitation Program; Other: Conventional Exercise Program |
| Conventional Exercise Group | Active comparator | Participants in this group will receive a 6-week conventional exercise program. Receives: Other: Conventional Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 3, and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start18 May 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups. The experimental group will receive pulmonary rehabilitation, including respiratory muscle training and upper extremity aerobic exercises. The control group will receive a conventional exercise program. Both groups will be assessed at baseline, week 3, and week 6.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Akçay, Fenerbahce University
- Investigators
- Sümeyye Akçay, Principal investigator, Fenerbahçe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577960
- Sponsor's protocol ID
- KartalH
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulmonary Rehabilitation on Respiratory Parameters in Individuals With Upper Extremity Burns
- ClinicalTrials.gov ID
- NCT07577960
- Acronym / sponsor ID
- KartalH
- Conditions
- Burn Injury, Pulmonary Rehabilitation
- Keywords
- Upper Extremity Burns, Pulmonary Rehabilitation, Respiratory Function
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The experimental group will receive pulmonary rehabilitation, including respiratory muscle training and upper extremity aerobic exercises. The control group will receive a conventional exercise program. Both groups will be assessed at baseline, week 3, and week 6.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation Group | Experimental | Other: Pulmonary Rehabilitation Program, Other: Conventional Exercise ProgramParticipants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises. |
| Conventional Exercise Group | Active comparator | Other: Conventional Exercise ProgramParticipants in this group will receive a 6-week conventional exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Rehabilitation ProgramParticipants 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. | Other | Pulmonary Rehabilitation Group |
| Conventional Exercise ProgramParticipants 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. | Other | Conventional Exercise Group, Pulmonary Rehabilitation Group |
Primary outcome
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.
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.
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.
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.
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.
Change in Diaphragm Excursion
Time frame: Baseline, week 3, and week 6
Diaphragm excursion will be assessed using ultrasonography to evaluate changes in diaphragm mobility over time. Diaphragm excursion will be reported in millimeters.
Change in 6-Minute Walk Distance
Time frame: Baseline, week 3, and week 6
Functional capacity will be assessed using the 6-minute walk test. The distance walked during the test will be recorded in meters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sümeyye Akçay principal investigator
Fenerbahçe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation Program and Conventional Exercise Program in people with Burn Injury and Pulmonary Rehabilitation, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Vital Capacity (time frame: Baseline, week 3, and week 6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.