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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Adile Neşe, Assoc Prof.
- Telefoonnummer: 03423172187
- E-mail: acaparusagi@hotmail.com
Studie Contact Back-up
- Naam: Adile Neşe, Assoc Prof
- Telefoonnummer: 03423172187
- E-mail: acaparusagi@hotmail.com
Studie Locaties
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Şehitkamil
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Gaziantep, Şehitkamil, Turkije (Türkiye), 27000
- Werving
- Gaziantep University Vocational School of Health Services
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Contact:
- Adile Neşe, Associate Professor
- Telefoonnummer: 03423172187
- E-mail: acaparusagi@hotmail.com
-
Contact:
- Adile Neşe, Associate Professor
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: Control Group
Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Fatigue severity measured by the FACIT-Fatigue Scale
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Respiratory function measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Adile Neşe, Associate Professor, University of Gaziantep
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SCLERODERMA
- 23.05.2025 (Register-ID: Gaziantep University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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