Association of Fear of Falling and Physical Activity in Rheumatoid Arthritis Comparison Before and After Biological Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To identify the prevalence and severity of the fear of falling in a rheumatoid population
研究概览
简要总结
Primary Objective:
To identify the prevalence and severity of the fear of falling in a rheumatoid population
Secondary Objectives:
To explore the effect the treatment with biological agents has on fear of falling and physical activity in a rheumatoid population
详细描述
The study will be an open, observational study to determine the prevalence of fear of falling in a rheumatoid population with severe disease being considered for biological therapy; this will be compared with physical activity levels at baseline and the change in these level pre and post treatment with biologic therapy. An age and sex matched control group will also be studied to allow inference to be drawn from the self reported 'fear of falling' and the objective activity levels of the RA population.
The study will consist of two visits: screening/baseline, and a 12 week follow up visit. It will be an observational study of the effects of the planned treatment regime via the NHS pathway. The subjects who are eligible to enter in the study will receive his/her normal treatment prescribed and be at the referral phase for biological treatment. The control group will continue on any existing treatments but will not have any reported physical limitations.
At the screening/baseline visit the self completion outcome questionnaires will be given to both the patient group and the control group. A disease activity score (aggregate score of RA symptoms - DAS) for the RA population will be calculated by a nurse specialist at the time of referral for the biological agent and again at 12 weeks post treatment, these parameters will not be repeated by the research team but the DAS score will be collected used in the final analysis. In addition, the Numact ambulatory activity recorder - used to assess spontaneous ambulatory activity - will be fitted for a 24hour period. This screening / baseline visit will occur before, but as near as possible to the 1st treatment day of the prescribed biological agent.
Occasionally the recording device may fail due to extraneous factors; in this instance a second recording may be required.
The control group will complete their study participation immediately after the screening / baseline visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To identify the prevalence and severity of the fear of falling in a rheumatoid population
次要结局
- To explore the effect the treatment with biological agents has on fear of falling and physical activity in a rheumatoid population