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Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns

4 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Turchia (Türkiye)
    • Kartal
      • Istanbul, Kartal, Turchia (Türkiye), 34865
        • Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Pulmonary Rehabilitation Group
Participants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises.
Altro: 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.
Altro: 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.
Comparatore attivo: Conventional Exercise Group
Participants in this group will receive a 6-week conventional exercise program.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Forced Vital Capacity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fenerbahce University

Investigatori

  • Investigatore principale: Sümeyye Akçay, Fenerbahçe University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KartalH

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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