Does Exercise Have an Impact on Sleep and Mood in People Who Have Rheumatoid Arthritis: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
Regular physical activity is important for people with rheumatoid arthritis (RA). Sleep requirements for adults should be on a 'sleep needs spectrum' of between 7 to 9 hours per day. Poor sleep is a common complaint among people with RA, which may have an effect on their activity levels and well-being. There is evidence that physical activity and exercise can improve sleep quality and disturbances in other chronic disease populations therefore, examining how same affects sleep in RA is important.
详细描述
Sleep is an important aspect in maintaining the body's circadian rhythm. In general getting fewer than 5 hours sleep per day has been associated with cardiovascular problems, diabetes and obesity and can also be linked to depression and anxiety. Poor sleep is a common complaint among people with rheumatoid arthritis (RA) with disturbed sleep and fatigue known to affect up to 70% in this population. Poor sleep quality may contribute to the feelings of pain, fatigue and poor psychological well-being which in turn may further deteriorate functional ability and reduced activity.
It is known that exercise improves a person's psychological state which can also be an additional factor in improving or indeed disrupting quality of sleep. Exercise has been identified as an important part of the nonpharmacological management of poor sleep and in improving sleep quality however, people with RA were previously cautioned about undertaking exercise. Therefore, changes in sleep quality during exercise intervention should be evaluated so that society can understand more the potential for long-term changes in overall health status, in people who have RA. Indeed the intensity level of the activity in people with RA may be of additional importance.
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
- Single (Outcomes Assessor)
盲法说明
At baseline assessment demographic information and outcome measures will be collected by a physiotherapist not involved in the intervention and will be blinded to which arm the participant has been allocated to. This will all take place at the Department of Clinical Therapies, University of Limerick.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be eligible to participate if they are aged 18-70; have a diagnosis of RA (defined by the American College of Rheumatology 1987 criteria); have poor sleep (Pittsburgh Sleep Quality Index global score >5); have a low disease score on 28 joints (DAS28) <3.2; Health Assessment Questionnaire result of <2.4 and are able to provided informed consent, understand and speak English. All the above will be determined should the person be interested in participating and before any fitness testing will be place.
排除标准
- •Participants will be excluded from the study if they have severe physical disability (HAQ score > 2.5); are pregnant; participate in regular physical activity in their leisure time (self-reported aerobic exercise > 5 times per week); have cardiac symptoms corresponding to New York Heart Association (NYHA) functional classification > 2;
研究组 & 干预措施
Exercise Intervention
The walking programme will consist of a total of 21 aerobic walking sessions, with 1 per week being supervised by a trained physiotherapist, spread over a maximum of eight weeks (2-3 times/week). During the first 4 weeks the intention is to increase frequency and the final 4 weeks the intensity, using the Borg Rate of Perceived exertion 6-20 or distance from 2km to 6km. The participants will attend the University of Limerick for a final assessment at week 9.
干预措施: Walking Programme (Behavioral)
Control Group
The control group will be given verbal and written instructions regarding the benefits of exercise in RA.
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: 8 Weeks
Sleep
次要结局
- State Trait Anxiety Inventory(up to 8 weeks)
- Profile of Moods State(up to 8 weeks)
- Quick Inventory of Depressive Symptomatology(up to 8 weeks)
- Disease Activity Score with 28 joints(up to 8 weeks)
- Exercise Benefits and Barriers Scale(up to 8 weeks)
- RA related Pain - visual analog scale (VAS) consisting of a 10cm horizontal line anchored from 0 (no pain) to 10 (worst pain possible).(up to 8 weeks follow up)
- Health Assessment disability Index(up to 8 weeks)
- Rheumatoid Arthritis-Specific Quality of Life Instrument(up to 8 weeks)
- Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire(up to 8 weeks)
研究者
Sean McKenna
PhD Candidate
University Hospital of Limerick