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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Adile Neşe, Assoc Prof.
- Número de teléfono: 03423172187
- Correo electrónico: acaparusagi@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Adile Neşe, Assoc Prof
- Número de teléfono: 03423172187
- Correo electrónico: acaparusagi@hotmail.com
Ubicaciones de estudio
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Şehitkamil
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Gaziantep, Şehitkamil, Turquía (Türkiye), 27000
- Reclutamiento
- Gaziantep University Vocational School of Health Services
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Contacto:
- Adile Neşe, Associate Professor
- Número de teléfono: 03423172187
- Correo electrónico: acaparusagi@hotmail.com
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Contacto:
- Adile Neşe, Associate Professor
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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Sin intervención: Control Group
Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fatigue severity measured by the FACIT-Fatigue Scale
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Respiratory function measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adile Neşe, Associate Professor, University of Gaziantep
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del tejido conectivo
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Enfermedades de la piel
- Signos y Síntomas Respiratorios
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Fatiga
- Esclerodermia Sistémica
- Esclerodermia Difusa
- Disnea
Otros números de identificación del estudio
- SCLERODERMA
- 23.05.2025 (Identificador de registro: Gaziantep University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
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