FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Total FIQ score
研究概览
简要总结
The goal of this clinical trial is to learn if the combination of two interventions is more effective in treating fibromyalgia symptoms than one intervention alone. The participant group will be people with fibromyalgia in age group 18-65 years. The two interventions to be tested over sixteen weeks are:
- weekly exercise sessions in groups
- weekly consultations with a therapist
The main question it aims to answer is: Is the combination of group exercising and somatic tracking work more efficient than physical activity alone in terms of managing fibromyalgia?
Participants will wear Fitbit activity trackers, register pain intensity daily on a mobile app, and answer the Fibromyalgia Impact Questionnaire (FIQ). They will be divided into four groups:
- one group receiving the exercise intervention
- one group receiving the psychological intervention
- one group receiving both intervention
- one control group recieving general physical activity recommendations
Before the sixteen weeks intervention period, there will be a baseline period of eight weeks. Durng the baseline period, participants will wear activity trackers and maintain their usual lifestyle.
Researchers will compare the combination of the interventions against only one intervention and the control group.
详细描述
Fibromyalgia is a chronic condition characterised by musculoskeletal pain, fatigue, poor sleep and an overall reduced quality of life. It is well known that physical activity improves symtpons of fibromyalgia, although not all people affected by the condition have positive experiences from exercising. People with fibromyalgia have also stated that physical activity alone is not enough for managing symptomes effectively. This is the background for the proposed randomized controlled trial with a 2*2 factorial design, where two interventions are tested, alone and in combination.
There will be a baseline period of 8 weeks and an intervention period of 16 weeks.
Evaluations will occur at the end of the baseline period (8 weeks) and at the end of the intervention period (24 weeks).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with fibromyalgia according to the criteria specified in Wolfe et al (2016)
- •Able to perform light physical activity
- •Able to provide written informed consent
- •Owning a smartphone
- •Able to be followed for 24 weeks
排除标准
- •Severe co-morbid psychiatric or neurological disorders
- •Current participation in another clinical trial
- •Recent surgery or other physical constraints preventing exercise
结局指标
主要结局
Total FIQ score
时间窗: At end of baseline (8 weeks) and post-intervention (24 weeks)
Fibromyalgia Impact Questionnaire (FIQ) is widely used in clinical trials in fibromyalgia patients. The questionnaire contains questions that are answered using a scale. The scores from each question are used to calculate a total FIQ score.
次要结局
- Steps per day(24 weeks)
- Resting heart rate(24 weeks)
- Insomnia Severity Index (ISI)(At end of baseline (8 weeks) and post-intervention (24 weeks))
- Self-reported pain intensity(24 weeks)
- Minutes lightly active(24 weeks)
- Minutes moderately active(24 weeks)
- Minutes very active(24 weeks)
- Sleep efficiency(24 weeks)