Land- and Water-Based Exercise Intervention in Women With Fibromyalgia: The Al-Andalus Physical Activity Randomised Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Overall impact of fibromyalgia
研究概览
简要总结
Background The Al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women with fibromyalgia.
Methods One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will be randomly assigned to a usual care (control) group (n=60), a water-based exercise intervention group (n=60) or a land-based exercise intervention group (n=60). Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 minutes each) per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises.
Discussion The investigators study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the Al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 35-65 years.
- •Meeting the American College of Rheumatology criteria: widespread pain for more than 3 months, and pain with 4 kg/cm of pressure reported for 11 or more of 18 tender points.
- •Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer "no" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q ).
- •Not to be engaged in regular physical activity >20 minutes on >3 days/week.
- •Planning to stay in the same Association during the study.
- •Able to ambulate, with or without assistance.
- •Able to communicate.
- •Informed consent: Must be capable and willing to provide consent.
排除标准
- •Acute or terminal illness.
- •Myocardial infarction in the past 3 months.
- •Not capable to ambulate.
- •Unstable cardiovascular disease or other medical condition.
- •Upper or lower extremity fracture in the past 3 months.
- •Severe dementia (MMSE<10).
- •Unwillingness to either complete the study requirements or to be randomised into control or training group.
- •Presence of neuromuscular disease or drugs affecting neuromuscular function.
结局指标
主要结局
Overall impact of fibromyalgia
时间窗: Participants will be followed over 24 weeks
The primary outcome will be assessed with the fibromyalgia Impact Questionnaire (FIQ). FIQ is a self-administered questionnaire, comprising 10 subscales of disabilities and symptoms (physical function, work missed day, job ability, feel good, pain, fatigue, sleep, stiffness, anxiety and depression) and has been validated for Spanish fibromyalgia patients. The total scores range from 0 to 100, with a higher score indicating greater effect of the condition on the person's life.
次要结局
- Tenderness(Participants will be followed over 24 weeks)
- Visual analogic scale for pain(Participants will be followed over 24 weeks)
- The Pain Catastrophizing Scale(Participants will be followed over 24 weeks)
- Body composition(Participants will be followed over 24 weeks)
- Cognitive function(Participants will be followed over 24 weeks)
- Functional capacity(Participants will be followed over 24 weeks)
- Fatigue(Participants will be followed over 24 weeks)
- Sleep Quality(Participants will be followed over 24 weeks)
- Health-related quality of life(Participants will be followed over 24 weeks)
研究者
Jonatan Ruiz Ruiz
Co-Coordinator, Junior Research Fellow
Universidad de Granada