Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns
3 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
64
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Kartal
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Istanbul, Kartal, Turquie (Türkiye), 34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Pulmonary Rehabilitation Group
Participants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises.
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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.
|
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Comparateur actif: Conventional Exercise Group
Participants in this group will receive a 6-week 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Forced Vital Capacity
Délai: Baseline, week 3, and week 6
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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.
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Baseline, week 3, and week 6
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Change in Forced Expiratory Volume in One Second
Délai: 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
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Change in Maximum Voluntary Ventilation
Délai: Baseline, week 3, and week 6
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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.
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Baseline, week 3, and week 6
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Change in Diaphragm Thickness During Inspiration
Délai: Baseline, week 3, and week 6
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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.
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Baseline, week 3, and week 6
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Change in Diaphragm Thickness During Expiration
Délai: Baseline, week 3, and week 6
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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.
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Baseline, week 3, and week 6
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Change in Diaphragm Excursion
Délai: Baseline, week 3, and week 6
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Diaphragm excursion will be assessed using ultrasonography to evaluate changes in diaphragm mobility over time.
Diaphragm excursion will be reported in millimeters.
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Baseline, week 3, and week 6
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Change in 6-Minute Walk Distance
Délai: Baseline, week 3, and week 6
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Functional capacity will be assessed using the 6-minute walk test.
The distance walked during the test will be recorded in meters.
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Baseline, week 3, and week 6
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Sümeyye Akçay, Fenerbahce University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 mai 2026
Achèvement primaire (Estimé)
1 septembre 2026
Achèvement de l'étude (Estimé)
1 septembre 2026
Dates d'inscription aux études
Première soumission
28 avril 2026
Première soumission répondant aux critères de contrôle qualité
4 mai 2026
Première publication (Réel)
11 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KartalH
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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