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Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns

4. Mai 2026 aktualisiert von: Sümeyye Akçay, Fenerbahce University

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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

64

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
    • Kartal
      • Istanbul, Kartal, Türkei (türkiye), 34865
        • Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Sonstiges: Pulmonary Rehabilitation 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.
Sonstiges: 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.
Aktiver Komparator: Conventional Exercise Group
Participants in this group will receive a 6-week conventional exercise program.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Forced Vital Capacity
Zeitfenster: 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
Change in Forced Expiratory Volume in One Second
Zeitfenster: 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
Zeitfenster: 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
Change in Diaphragm Thickness During Inspiration
Zeitfenster: 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.
Baseline, week 3, and week 6
Change in Diaphragm Thickness During Expiration
Zeitfenster: 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
Change in Diaphragm Excursion
Zeitfenster: 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.
Baseline, week 3, and week 6
Change in 6-Minute Walk Distance
Zeitfenster: 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.
Baseline, week 3, and week 6

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fenerbahce University

Ermittler

  • Hauptermittler: Sümeyye Akçay, Fenerbahçe University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

1. September 2026

Studienabschluss (Geschätzt)

1. September 2026

Studienanmeldedaten

Zuerst eingereicht

28. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Mai 2026

Zuerst gepostet (Tatsächlich)

11. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KartalH

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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