The Effect of Clinical Pilates Training on Fatigue, Emotional State, Functional Capacity, Sleep and Quality of Life in Women With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fatigue status (Fatigue Severity Scale)
研究概览
简要总结
Systemic lupus erythematosus (SLE) is a chronic, autoimmune, inflammatory disease with the potential to affect any organ in the body. The most frequently affected anatomical regions include the skin, joints, pleura, pericardium, kidneys and the central nervous system.
All systemic conditions observed in SLE cause functional deficiencies in daily life, fatigue, anxiety and depression, pain, sleep quality disorders, cognitive effects, cosmetic problems, social isolation, and all these characteristics negatively affect the quality of life of an individual with SLE.
The aim of this study is to investigate the effects of clinical pilates exercises on pain, fatigue, functional capacity, flexibility, emotional state, sleep and quality of life in patients with SLE.
详细描述
The Effect of Clinical Pilates Training on Fatigue, Emotional State, Functional Capacity, Sleep and Quality of Life in Women with Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, autoimmune, inflammatory disease with the potential to affect any organ in the body. The most frequently affected anatomical regions include the skin, joints, pleura, pericardium, kidneys and the central nervous system.
All systemic conditions observed in SLE cause functional deficiencies in daily life, fatigue, anxiety and depression, pain, sleep quality disorders, cognitive effects, cosmetic problems, social isolation, and all these characteristics negatively affect the quality of life of an individual with SLE.
The aim of this study is to investigate the effects of clinical pilates exercises on pain, fatigue, functional capacity, flexibility, emotional state, sleep and quality of life in patients with SLE.
The objectives of this study are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •being a woman between the 18 Years to 65 Years ,
- •meeting the American College of Rheumatology SLE diagnostic criteria,
- •having low disease activity (SLEDAI ≤4),
- •agreeing to participate in the study
排除标准
- •presence of malignancy, pregnancy, change of treatment within the last 3 months,
- •use of steroids equivalent to >16 mg prednisolone for the last 3 months, - -
- •have other rheumatic diseases,
- •have a regular exercise habit (physical activity more than two times a week),
- •have a disease that restricts physical activity (such as neurological disorder, orthopedic disorder, cognitive disorder, immobility),
- •have serious heart, lung or kidney involvement,
- •uncontrolled hypertension,
- •severe anemia (hb <8 g/dL),
- •having undergone orthopedic surgery in the last 6 months
研究组 & 干预措施
Intervention group
The intervention group will participate in supervised clinical Pilates exercises. These exercises will be administered in the form of group sessions, which are to be held twice per week. In addition to the home exercise program, which is to be followed for a period of eight weeks.
干预措施: Clinical Pilates Training (Other)
Intervention group
The intervention group will participate in supervised clinical Pilates exercises. These exercises will be administered in the form of group sessions, which are to be held twice per week. In addition to the home exercise program, which is to be followed for a period of eight weeks.
干预措施: Home exercise program (Other)
Control group
The control group will be provided with a home exercise program. This program will consist of stretching, relaxation, and strengthening exercises, to be performed three days a week for a period of eight weeks.
干预措施: Home exercise program (Other)
结局指标
主要结局
Fatigue status (Fatigue Severity Scale)
时间窗: 5 months
The patient's fatigue status will be evaluated using the fatigue severity scale (FSS). The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items.
次要结局
- Pain score (Visual Analog Scale)(5 months)
- Emotional state (Hospital Anxiety and Depression Scale)(5 months)
- Functional capacity (6-minute walking test, 30-second sitting test, Handgrip measurement)(5 months)
- Sleep quality (Jenkins sleep scale)(5 months)
- SLE quality of life (Systemic lupus erythematosus quality of life scale)(5 months)
- Functional status (Health assessment questionnaire)(5 months)
研究者
Emir İbrahim IŞIK
Asst. Prof.
Cukurova University