Progressive Resisted Exercise Program Combined With Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus Patients, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Bone Mineral Density
研究概览
简要总结
systemic lupus erythematosus (SLE) is the most common autoimmune disease in women of childbearing age. Promoting physical activity is a major national priority for the general population, including patients with chronic diseases. The aim of this study is to investigate the efficiency of combined effect of progressive resisted exercise with aerobic exercise for bone mineral density, quality of life, muscle strength and physical activity for patients with SLE.
详细描述
The following factors were found to be significantly related to lower BMD by univariate analysis: Caucasian race, older age at diagnosis, higher age at the time of the first DXA, longer disease duration, higher cumulative corticosteroid dose, lower serum levels of 25(OH)D, higher SLE Damage Index score, and postmenopausal status. In the multivariate analysis only the following factors were significant: Caucasian race, increased number of pregnancies, postmenopausal status, higher SLE Damage Index, and higher cumulative corticosteroid dose.
As the quality of life among patients with SLE not fully associated with SLE disease activity, pharmacologic treatments that are effective for SLE disease activity might not be able to improve quality of life in these patients Therefore, the benefit of nonpharmacological therapies on quality of life has been explored.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of systemic lupus erythematosus by the classification criteria ACRa and the 2019 EULARb/ACR Classification Criteria for systemic lupus erythematosus
- •Systemic Lupus Erythematosus Disease Activity Index ≥4
- •For 30 day prior, stable immunosuppressive therapy with steroid (0-20 mg/day) or other immunosuppressive medication such as hydroxychloroquine, chloroquine, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, belimumab, rituximab
排除标准
- •Those who are pregnant.
- •Patients with active lupus nephritis, cardiovascular dysfunction, rhythm and conduction disorders.
- •Patients with musculoskeletal disturbances; kidney and pulmonary involvements; peripheral neuropathy and fibromyalgia.
- •Use of tobacco; treatment with lipid-lowering, chronotropic or antihypertensive drugs
研究组 & 干预措施
Aerobic exercise plus progressive resisted exercise group
Will receive aerobic exercise, progressive resisted exercise in addition to traditional care.
干预措施: Progressive resisted exercise training (Other)
Aerobic exercise plus progressive resisted exercise group
Will receive aerobic exercise, progressive resisted exercise in addition to traditional care.
干预措施: Calcium and Vit D (Drug)
Aerobic exercise plus progressive resisted exercise group
Will receive aerobic exercise, progressive resisted exercise in addition to traditional care.
干预措施: Aerobic exercises (Other)
Aerobic exercise group
Will receive aerobic exercise plus traditional care.
干预措施: Calcium and Vit D (Drug)
Aerobic exercise group
Will receive aerobic exercise plus traditional care.
干预措施: Aerobic exercises (Other)
Progressive resisted exercise group
Will receive progressive resisted exercise
干预措施: Progressive resisted exercise training (Other)
Progressive resisted exercise group
Will receive progressive resisted exercise
干预措施: Calcium and Vit D (Drug)
Control group
Will receive traditional medical treatment in the form of Calcium, Vit D and Bi phosphnate.
干预措施: Calcium and Vit D (Drug)
结局指标
主要结局
Bone Mineral Density
时间窗: follow up after 3 months
It will be measured at the lumbar spine and proximal femur by means of dual-energy x-ray
次要结局
- Muscle strength assessment(follow up after 3 months)
- Level of physical activity(follow up after 3 months)
- Quality of life (36-Item Short Form Health Survey)(follow up after 3 months)
研究者
Nesma Morgan Allam
Assistant Professor of physical therapy for surgery, Faculty of physical therapy
Cairo University