Effects of a Personalized Physical Training to Reduce Fatigue in Chronic Fatigue Patients: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure.
研究概览
简要总结
Chronic fatigue (CF) is a pathological fatigue over at least 6 months, without improvement after rest or sleep. In primary care, it is the major complaint in 5 to 10% of the consultations. Physical activity is an efficient therapy to help reducing this fatigue in addition to the improvement of muscular and cardiorespiratory functions. However, it remains little exploited. Yet the studies focus mainly on precise chronic pathologies with general trainings, without considering the fatigue status and reveal a large heterogeneity. Personalizing the physical training appears to be the next step in order to improve chronic fatigue patients care.
The objective of this study will be to investigate the relevance and the effects of a personalized physical training to reduce fatigue in chronic fatigue patients.
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
- 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
- •Aged ≥ 18
- •Men or women
- •FACIT-F score ≤ 34
- •Ability to walk during 10 minutes without stopping
- •Ability to receive the Myocene® stimulation protocol
- •Have given written consent
- •Members or beneficiaries of a social security program
排除标准
- •Contraindication to experimental procedures
- •Important health issues that would compromise the participant security during the study
- •Persistent atrial fibrillation or 2nd or 3rd degree atrioventricular block
- •Currently participating in an other interventional study or having so in the past thirty days
- •Patient is pregnant
- •Patient is unable to give an informed consent
- •Patient is deprived of liberty or under guardianship
研究组 & 干预措施
Personalized training group with the fatigue status (PERSO)
The PERSO group will perform similar exercises as the RECO group but the training load will be adapted by changing the intensity (with the same volume as RECO) depending on the fatigue scores of the week. The aerobic fatigue score will set the load for the aerobic exercises and the muscle fatigue score for the resistance exercises.
干预措施: Exercise protocol (Other)
Traditional training group following the recommendations (RECO)
The RECO group will perform aerobic and resistance exercises to reach the recommendations for patients with chronic pathologies, with a moderate intensity and an increasing volume.
干预措施: Exercise protocol (Other)
结局指标
主要结局
The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure.
时间窗: Month 1, 4
The FACIT-F (Functional Assessment of Chronic Illness Therapy) is a short questionnaire consisting of 13 questions which the patient answers on a scale of 0 to 4. The scores are simply added together, inverting the scale for negative sentences, to give a result out of 52 points. The lower the score, the greater the fatigue.
次要结局
未报告次要终点