The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis (PMR-SCLERODERM)
The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis: A Randomized Controlled Trial
This study aims to evaluate the effects of progressive muscle relaxation exercises on fatigue, dyspnea, and respiratory function in patients with systemic sclerosis. Participants will be assessed before and after the intervention.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Systemic sclerosis is a chronic autoimmune connective tissue disease that can affect multiple organs, including the respiratory system. Respiratory involvement may lead to symptoms such as dyspnea and fatigue and may adversely affect respiratory function and quality of life.
Progressive muscle relaxation exercise is a non-pharmacological relaxation technique that involves systematically tensing and relaxing different muscle groups. This technique may reduce physical and psychological tension and may contribute to the management of symptoms such as fatigue and dyspnea.
The purpose of this study is to evaluate the effect of progressive muscle relaxation exercises on fatigue, dyspnea, and respiratory function in patients with systemic sclerosis. Participants will undergo baseline assessments before the intervention. Progressive muscle relaxation exercises will then be administered, followed by post-intervention assessments to determine changes in fatigue, dyspnea, and respiratory function.
The findings of this study may provide evidence regarding the potential use of progressive muscle relaxation exercises as a supportive non-pharmacological intervention for symptom management in patients with systemic sclerosis.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Adile Neşe, Assoc Prof.
- Numero di telefono: 03423172187
- Email: acaparusagi@hotmail.com
Backup dei contatti dello studio
- Nome: Adile Neşe, Assoc Prof
- Numero di telefono: 03423172187
- Email: acaparusagi@hotmail.com
Luoghi di studio
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Şehitkamil
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Gaziantep, Şehitkamil, Turchia (Türkiye), 27000
- Reclutamento
- Gaziantep University Vocational School of Health Services
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Contatto:
- Adile Neşe, Associate Professor
- Numero di telefono: 03423172187
- Email: acaparusagi@hotmail.com
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Contatto:
- Adile Neşe, Associate Professor
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:Individuals who meet the study eligibility criteria will be included in the study. Eligible participants will be adults aged 18 years or older, diagnosed with systemic sclerosis, and have adequate physical and cognitive capacity to participate in the study.
Exclusion Criteria:Individuals who do not meet the inclusion criteria, who are unable to participate in the progressive muscle relaxation exercises due to their physical or cognitive condition, or who withdraw from the study voluntarily will be excluded from the study.
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Progressive Muscle Relaxation Exercise Group
Participants randomly assigned to this group will receive progressive muscle relaxation exercises in addition to standard care. |
Participants in the intervention group will receive progressive muscle relaxation exercises according to the study protocol. The intervention will be administered in addition to standard care. |
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Nessun intervento: Control Group
Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fatigue severity measured by the FACIT-Fatigue Scale
Lasso di tempo: Baseline and 4 weeks after the intervention
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Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. Changes in fatigue scores from baseline to post-intervention assessment will be evaluated between the intervention and control groups. |
Baseline and 4 weeks after the intervention
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Dyspnea severity measured by the Dyspnea-12 (D-12) Scale
Lasso di tempo: Baseline and 4 weeks after the intervention
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Dyspnea will be assessed using the Dyspnea-12 (D-12) Scale. Changes in dyspnea scores from baseline to post-intervention assessment will be evaluated between the intervention and control groups. |
Baseline and 4 weeks after the intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Respiratory function measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Lasso di tempo: Baseline and 4 weeks after the intervention
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Respiratory function will be assessed using spirometry, including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC). Changes in FEV1 and FVC from baseline to post-intervention assessment will be evaluated between the intervention and control groups. |
Baseline and 4 weeks after the intervention
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Adile Neşe, Associate Professor, University of Gaziantep
Pubblicazioni e link utili
Pubblicazioni generali
- Fairley JL, Hansen D, Proudman S, Baron M, Sahhar J, Ngian GS, Walker J, Host LV, Morrisroe K, Stevens W, Ross L, Nikpour M. The burden and determinants of fatigue in incident and prevalent systemic sclerosis. Clin Exp Rheumatol. 2024 Aug;42(8):1669-1674. doi: 10.55563/clinexprheumatol/6528od. Epub 2024 Aug 14.
- Yakut H, Ozalevli S, Birlik AM. Fatigue and its relationship with disease-related factors in patients with systemic sclerosis: A cross-sectional study. Turk J Med Sci. 2021 Apr 30;51(2):530-539. doi: 10.3906/sag-2005-314.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SCLERODERMA
- 23.05.2025 (Identificatore di registro: Gaziantep University)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Individual participant data will not be shared with other researchers. Data will be used only for the purposes of this study and will be handled in accordance with applicable ethical and data protection requirements.
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