Medical Benefit Evaluation of Ambulatory Activity Combining Rehabilitation and Therapeutic Education, Using an Intelligent Electric Bike for the Health, for the Effort Rehabilitation and the Quality of Life Improvement for Patients Suffering of Moderate Fibromyalgia.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 主要终点
- Decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education.
研究概览
简要总结
The aim of this study is to decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education workshop.
详细描述
Fibromyalgia is chronic pain syndrome expressed as fluctuacting musculotendinous or articular pain and chronic tiredness. Among the non-pharmacological treatments, apart the "psychological" accompanying, the EULAR (European League Against Reumatism) recommends the physical activity in first intention. Thus, physical reconditioning has an important place in fibromyalgia. Aerobic conditioning or reconditioning programs for effort induce for some patients a benefit on quality of life, tiredness and pain. In France, these programmes are mostly carried out in "follow-up and rehabilitation" type care structures.
Outdoor exercise re-training with the Intelligent Electric Bike for Health combined with therapeutic education sessions are proposed in the study. These activities, adapted to each group and patient, can best achieve the objective in an ambulatory format closer to the patient's daily life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 and over
- •Patient available for a following of 18 months
- •Patient available for go to sessions of Intelligent Electric Bike for the Health, 2 half-day by week during 8 weeks in the 2 months following the randomization.
- •confirmed fibromyalgia according to the criteria of the American College of Rhumatology 2010 since at least one year with a stable treatment since at least 3 months.
- •Patients with a score of 39 ≤ FIQ < 59 (moderate fibromyalgia impact)
- •Patient in capacity to pedal on a bike outside.
- •Patient who haven't contraindications at the practice of an moderate physical activity or bike (acute coronary pathology less than 2 years, locomotor problems of the spine or lower limbs incompatible with the bike practice).
- •Weight lower than 125 kg (maximal load for the Intelligent Electric Bike for the Health).
- •Patient having signed the written consent after appropriate information and delivery of the information note.
- •Patient affiliated at the social security or beneficiary of such a scheme
排除标准
- •Substantial variation of the therapeutic care in the 3 months previous the inclusion (change of drug class, beginning of physical reconditioning in an unit of follow-up and rehabilitation care, or a cognitive-behavioral technique)
- •Patient with treatement which can deteriorate the attention
- •Patient suffering of a serious chronic desease destabilized (acute coronary pathology and/ or CVA in the last 6 months, serious asthma, serious heart failure, respiratory, lung or kidney failure, progressive inflammatory rheumatic disease...)
- •Women under contraception and with a pregnancy project
- •Patient already includes in a research protocol involving the human person
- •Protected persons
结局指标
主要结局
Decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education.
时间窗: 6 months
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) at 6 months compared to baseline.
次要结局
- Diminuate the health care consumption of the subjects at 3, 6 and 12 months compared to baseline.(3, 6 and 12 months)
- Evaluation of the kinetic of the evolution at the inclusion, at short-term (3 months), at medium-term (6 months) and at long-term (12 months) of the FIQ (Fibromyalgia Impact Questionnaire).(3, 6 and 12 months)
- Improve the global quality of life(3, 6 and 12 months)
- Study the impact of the Fibrovelis program on the evolution of the muscular parameter.(3 months (second to last trip of the intervention program).)
- Evaluate the effect size of the intervention between 12 and 18 months for the diferred intervention group.(12 and 18 months)
- In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the muscular power parameters.(3 months)
- Improve the mood(3, 6 and 12 months)
- Improve the perception of the impact of the disease in the relations with close relations(3, 6 and 12 months)
- Compare the percentage of patients who achieve an FIQ<39 at 6 months (threshold defining an fibromyalgia impact weak).(6 months)
- Improve self-esteem(3, 6 and 12 months)
- Study the impact of the Fibrovelis program on the evolution of cardio-respiratory physiological efficiency parameter.(3 months (second to last trip of the intervention program).)
- Evaluate the remanence of the long-term effect for the immediate intervention group(18 months)
- In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the cardio respiratory parameters.(3 months)
- Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).(3, 6 and 12 months)