- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07577960
Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns
The Effect of Pulmonary Rehabilitation on Respiratory Parameters in Individuals With Upper Extremity Burns
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Kartal
-
Istanbul, Kartal, Tyrkiet (Türkiye), 34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Pulmonary Rehabilitation Group
Participants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises.
|
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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Forced Vital Capacity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sümeyye Akçay, Fenerbahçe University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KartalH
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lungerehabilitering
-
Imperial College LondonImperial College Healthcare NHS TrustAfsluttetResearch With Clinical Staff in Stroke RehabilitationDet Forenede Kongerige
Kliniske forsøg med Pulmonary Rehabilitation Program
-
Uskudar State HospitalIkke rekrutterer endnuLungesygdom | Lungerehabilitering | Telesundhed
-
VA Office of Research and DevelopmentIkke rekrutterer endnuKardiovaskulær sygdom | HjerterehabiliteringForenede Stater
-
Universitat Jaume IHospital Vall d'Hebron; Villa Beretta Rehabilitation Research innovation... og andre samarbejdspartnereIkke rekrutterer endnuKronisk lænderygsmerter (CLBP)
-
Jouf UniversityIkke rekrutterer endnuHofteudviklingsdysplasi
-
The Hong Kong Polytechnic UniversityAfsluttet
-
Dokuz Eylul UniversityAfsluttet
-
First Affiliated Hospital of Shantou University...AfsluttetRekonstruktion af forreste korsbånd (ACL). | Præoperativ genoptræningKina
-
University of AlbertaAfsluttetKronisk obstruktiv lungesygdomCanada
-
SABAMED Medical Center Ltd.RekrutteringOrtostatisk hypotension | Mikrovaskulær angina | Ventrikulær arytmi | Vasospastisk angina | Autonom dysfunktion | Raynauds fænomener | Autonome sygdomme | Vasovagal syndrom VVS | Cardioinhibitory carotis sinus syndrom CSS | Symptomatisk sinus Bradycardia SB eller atrioventrikulær blok AV | Postural Orthostatic... og andre forholdPolen
-
Rostrum Medical Innovations Inc.Medical InitiativesIkke rekrutterer endnuSlag | Lungebetændelse | KOL | Akut lungeskade/akut respiratorisk distress syndrom (ARDS) | Ventilatorer, mekaniskeFrankrig, Forenede Stater, Østrig, Tjekkiet