Aerobic Exercise Versus Whole-Body Vibration On Fatigue, Functional Capacity And Quality Of Life In Patients With Systemic Lupus Erythematosus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Health Assessment Questionnaire(HAQ)
研究概览
简要总结
PURPOSE: ... The aim of this study will be conducted to investigate the therapeutic efficacy of Aerobic exercise versus whole-body vibration on fatigue, functional capacity and quality of life in patients with systemic lupus erythematosus
RESEARCH QUESTION:
The problem of the study will be designed in a questioner form " which is more effective Aerobic Exercise or Whole-Body Vibration on Fatigue, Functional Capacity And Quality Of Life In Patients With Systemic Lupus Erythematosus?
详细描述
Procedures of the study:
The assessment procedures
- Measuring of functional capacity and health-related quality of life in Systemic Lupus Erythematosus patients by:
The Systemic Lupus Erythematosus Quality of Life (SLEQOL) questionnaire SLEQoL is a 40-item questionnaire that was developed and validated in an English-speaking cohort of SLE patients in Singapore and it assesses the quality of life of Systemic Lupus Erythematosus (SLE) patients across six domains including physical functioning, occupational activities, symptoms, treatment, mood and self-image.
Arabic version of the SLEQOL The questionnaire which is a reliable and valid specific instrument for measuring the quality of life of Egyptian SLE patients, cross-cultural adaptation and validation of SLEQoL has been performed in Arabic (Egypt). Each domain score varies from 1 to 7, with higher scores indicating poorer quality of life. The total scores of the questionnaire vary between 40 and 280.
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
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Criteria for selecting the patients include the following:
- •This study turned will be done on 68 patients.
- •Age range between 25-45 years.
- •Female patients with a diagnosis of Systemic Lupus Erythematosus (SLE).
- •A follow-up of 12 months.
- •Clinical and treatment stability during the 6 previous months.
- •Not performing regular exercise.
- •All patients enrolled in the study will have their informed consent
排除标准
- •The subjects are excluded from the study if they will meet one of the following criteria;
- •Have had biological treatment in the previous 6 months.
- •A background of clinical cardiovascular disease in the previous year.
- •Present contraindications to performing the exercise.
- •Other associated rheumatic diseases, pregnancy, active acute or chronic infection.
- •Acute renal failure, cardiac or pulmonary involvement.
- •Have a depressive disorder.
- •Undergo total hip replacement.
- •Diabetes, cancer.
结局指标
主要结局
Health Assessment Questionnaire(HAQ)
时间窗: 2 hours
Health Assessment Questionnaire (HAQ)It contains 20 questions grouped into eight subscales The response categories are "without any difficulty" (score = 0),"with some difficulty" (score = 1), "with much difficulty" (score = 2), and "unable to do" (score = 3).
functional capacity and health-related quality of life The Systemic Lupus Erythematosus Quality of Life (SLEQOL) questionnaire
时间窗: 2 hours
SLEQoL is a 40-item questionnaire and it assesses the quality of life of Systemic Lupus Erythematosus (SLE) patients across six domains including physical functioning, occupational activities, symptoms, treatment, mood and self-image. Each domain score varies from 1 to 7, with higher scores indicating poorer quality of life. The total scores of the questionnaire vary between 40 and 280.
Measuring of fatigue in Systemic Lupus Erythematosus patients by: Fatigue severity scale
时间窗: 2 hours
Fatigue severity scale The Fatigue severity scale (FSS) is a self-reported questionnaire It consists of 9 statements that rate the severity of the patient's fatigue symptoms in terms of how these symptoms affect motivation, exercise, physical function, and activities of daily living. Reflecting on their condition, patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement). Arabic version of the FSS-Arabic (FSS-Ar) The development of an Arabic version of the FSS-Arabic (FSS-Ar) and its validation would be of great value, as it would allow clinicians and researchers to investigate the incidence and impact of fatigue associated with it
次要结局
未报告次要终点
研究者
Ereny Sobhy Wahba Khalil
Assistant professor of physical therapy for surgery - Faculty of physical therapy, Cairo University
Cairo University