The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Respiratory function measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Participants and outcome assessors are blinded to group allocation. The researcher administering the intervention is aware of the group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Progressive Muscle Relaxation Exercise Group
Participants randomly assigned to this group will receive progressive muscle relaxation exercises in addition to standard care.
干预措施: Progressive Muscle Relaxation Exercise (Behavioral)
Control Group
Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises.
结局指标
主要结局
Respiratory function measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
时间窗: Baseline and 4 weeks after the intervention
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.
Fatigue severity measured by the FACIT-Fatigue Scale
时间窗: Baseline and 4 weeks after the intervention
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.
Dyspnea severity measured by the Dyspnea-12 (D-12) Scale
时间窗: Baseline and 4 weeks after the intervention
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.
次要结局
未报告次要终点
研究者
Adile Nese
Assistant Professor
University of Gaziantep