Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns

NCT07577960 | Enrolling By Invitation

• 1 other identifier: KartalH
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Burn Injury; Pulmonary Rehabilitation

Keywords

Upper Extremity Burns; Pulmonary Rehabilitation; Respiratory Function

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline, week 3, and week 6

Study Arms (2)

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.

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.

Other: Conventional Exercise Program

Interventions

Pulmonary Rehabilitation Program OTHER

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.

Pulmonary Rehabilitation Group

Conventional Exercise Program OTHER

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.

Conventional Exercise Group; Pulmonary Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burns; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sümeyye Akçay

  Fenerbahçe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to group allocation. Participants will be randomly assigned to the pulmonary rehabilitation group or the control group, and outcome measurements will be performed by an assessor who is not involved in the intervention program and is unaware of the participants' group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)