The Impact of Exercise on Hand Function, on Activities of Daily Living (ADLs) Performance and Quality of Life of Patients With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- change of DASH questionnaire
研究概览
简要总结
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria were randomly assigned to the exercise group (n=32) or the control group (n=30).
Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.
详细描述
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria [age>18, upper limb arthralgias, and DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire score>10)] were randomly assigned to the exercise group (n=32) or the control group (n=30).
Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.
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
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
- •SLE patients fulfilling the SLICC classification criteria
- •Upper limb arthralgias
- •DASH score>10
- •Stable drug regimen≥3 months
排除标准
- •Hand fracture or surgery in last 6 months
- •Physiotherapy program in last month
研究组 & 干预措施
EXERCISE GROUP
Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises (Hand exercise), of 30 minutes duration daily, for 12 weeks in addition to medical care.
干预措施: HAND EXERCISE (Behavioral)
CONTROL GROUP
Patients in the control group continued their usual medical care.
结局指标
主要结局
change of DASH questionnaire
时间窗: Baseline, 6, 12, 24 weeks
Hand function was measured with DASH Questionnaire
次要结局
- change of Grip strength(Baseline, 6, 12, 24 weeks)
- change of Quality of Life(Baseline, 6, 12, 24 weeks)
- change of HAQ questionnaire(Baseline, 6, 12, 24 weeks)
- change of Pinch strength(Baseline, 6, 12, 24 weeks)
- change of Dexterity(Baseline, 6, 12, 24 weeks)
研究者
Maria Tektonidou
Ass. Professor Medical School
National and Kapodistrian University of Athens