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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Adile Neşe, Assoc Prof.
- Telefonnummer: 03423172187
- E-Mail: acaparusagi@hotmail.com
Studieren Sie die Kontaktsicherung
- Name: Adile Neşe, Assoc Prof
- Telefonnummer: 03423172187
- E-Mail: acaparusagi@hotmail.com
Studienorte
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Şehitkamil
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Gaziantep, Şehitkamil, Türkei (türkiye), 27000
- Rekrutierung
- Gaziantep University Vocational School of Health Services
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Kontakt:
- Adile Neşe, Associate Professor
- Telefonnummer: 03423172187
- E-Mail: acaparusagi@hotmail.com
-
Kontakt:
- Adile Neşe, Associate Professor
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Kein Eingriff: Control Group
Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Fatigue severity measured by the FACIT-Fatigue Scale
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Respiratory function measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Adile Neşe, Associate Professor, University of Gaziantep
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SCLERODERMA
- 23.05.2025 (Registrierungskennung: Gaziantep University)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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