NCT02140866已完成不适用
Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Randomized Controlled Trial
Parker Research Institute1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The Assessment of Motor and Process Skills (AMPS) - the motor skill scale
研究概览
简要总结
The study examines whether hand exercise therapy as an add on to a compensatory intervention program focused on joint protection, assistive devices and alternative methods of doing will improve the performance of ADL tasks requiring hand function in patients with rheumatoid arthritis (RA).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex.
- •Diagnosis of rheumatoid arthritis (2).
- •Involvement of the hands, due to minimum one tender wrist, metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint in one of the hands.
- •Be on stable medication for at least 3 months prior to participation.
- •Self-reported decreased ability to perform personal and instrumental ADL tasks involving the hands.
排除标准
- •Significant osteoarthritis of the hand assessed at the initial examination by the rheumatologist
- •Hand surgery within 6 months of study participation
- •Other pain condition involving muscles and/or joints, e.g. fibromyalgia.
- •Prednisolon therapy, change in dose of biological agent or start of treatment with a new biological agent within the last 3 month before study start.
- •Inability to understand the information or to speak Danish
- •Any other condition that in the opinion of the investigator or accessing rheumatologist puts an otherwise eligible participant at increased risk by participation or otherwise make the person unfit for participation.
研究组 & 干预措施
Hand Exercise
Experimental
The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP).
干预措施: Hand Exercise (Other)
Compensatory Intervention Program (CIP)
Active Comparator
The control group will receive the Compensatory Intervention Program (CIP) only.
干预措施: Compensatory Intervention Program (CIP) (Other)
结局指标
主要结局
The Assessment of Motor and Process Skills (AMPS) - the motor skill scale
时间窗: within 2 weeks post intervention
次要结局
- The Assessment of Motor and Process Skills(AMPS) - the process skill scale(within 2 weeks post intervention)
- The Activities of Daily Living Questionnaire (ADL-Q)(within 2 weeks post intervention)
- Health Assessment Questionnaire (HAQ)(within 2 weeks post intervention)
- Overall disease activity (DAS-28)(within 2 weeks post intervention)
- Grip strength(within 2 weeks post intervention)
研究者
Eva Ejlersen Wæhrens
Senior researcher, PhD
Parker Research Institute
研究点 (1)
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