Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Primary Care Intervention in Fibromyalgia and Chronic Fatigue Syndrome: SYNCHRONIZE + Mixed Methods Study Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- change in quality of life
研究概览
简要总结
Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. However, nutrition and chronobiology are often not approached in-depth despite their potential. Furthermore, programs addressed to Chronic Fatigue Syndrome are still scare. This study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in Fibromyalgia and Chronic Fatigue syndrome.
详细描述
The investigators will perform a mixed study through a randomized clinical trial in Catalonian Primary Care with patients diagnosed of Fibromyalgia (M79.7) or both Fibromyalgia and Chronic Fatigue Syndrome (G93.3). The control group will follow the usual clinical practice and the intervention group, the usual practice plus the studied intervention (12 hours in 4 days). The intervention (based on nutrition, chronobiology and physical exercise) will be designed taking into account participant's opinion through focus groups. In both groups, quality of life (EuroQol-5D), as well as MFI, VAS pain, PSQI, erMEDAS-17, BRIAN, REGICOR-Short, FIQR and HADs questionnaires will be collected, prior to the intervention, and 1, 3, 6 and 12 months post-intervention. Food intake, body composition, resistance and strength will also be evaluated. The effect size will be calculated using Cohen's d and logistic regression models will be used to quantify the impact of the intervention by adjusting for different variables. In addition, a qualitative analysis with a descriptive phenomenological perspective from post-intervention focus groups of participants and professionals will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •People aged 18-65, recent diagnosis of Fibromyalgia (M79.1) (<10 years), or diagnosis of Fibromyalgia and Chronic Fatigue Syndrome (M79 .7 and G93.3), with availability, motivation and interest in the intervention.
排除标准
- •not meeting the inclusion criteria, being participating in other group interventions aimed at the treatment of these syndromes, presence of severe mental comorbidity or other relevant medical disorders or pathologies that may interfere with the evaluation of the intervention
结局指标
主要结局
change in quality of life
时间窗: change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention
to be evaluated with the EuroQol-5D questionnaire. It will be measured by a scale Likert: 0 (worst health) to 100 (better health) and a descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; with five levels of severity in each dimension: no problems, mild problems, moderate problems, severe problems, and extreme problems/impossibility.
次要结局
- change in fatigue indicator(change from fatigue indicator at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in sleep quality and insomnia indicator(change from sleep quality and insomnia indicator at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in pain indicator(change from pain indicator at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in adherence to the Mediterranean diet(change from adherence to the Mediterranean diet at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in physical exercise practice and sedentary lifestyle(change from physical exercise practice and sedentary lifestyle at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in circadian biological rhythm(change from circadian biological rhythm at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in functional impact of fibromyalgia(change from functional impact of fibromyalgia at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in mood indicator (anxiety)(change from mood indicator (anxiety) at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in food intake(change from food intake at at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in body mass index (BMI)(change from BMI at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in body fat(change from body fat at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in skeletal muscle(change from skeletal muscle at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in endurance(change from endurance at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in lower body muscular strength(change from lower body muscular strength at 1, 3, 6 and 12 months after the beginning of the intervention)
- change in upper body muscular strength(change from upper body muscular strength at at 1, 3, 6 and 12 months after the beginning of the intervention)