Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fatigue evaluation assessed by autonomic nervous system activity
研究概览
简要总结
Chronic fatigue is enhanced by adapted physical activity (APA) programs. Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid benefit from a 4-6 week APA program, with 2 sessions per week. While most patients are improved by these exercise-training programs, for some the benefits remain very modest, and patients describe persistent fatigue. The literature unanimously describes the necessity of longer APA protocols (8-12 weeks, 2-3 sessions/week) for fatigue reduction in fibromyalgia and long Covid. However, it seems difficult to adhere to an optimal program as described in the literature for these fatigued patients. The investigators want to test a device that would both reduce fatigue and improve recovery between APA sessions, in order to gradually reach the recommendations for APA practice. Transcutaneous vagal nerve stimulation (tVNS) seems to be a promising approach. Thus, combining an APA intervention with a tVNS protocol could potentiate the expected and now well-known effect of exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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 over 18 years old
- •Signature of informed consent
- •Confirmed diagnosis of fibromyalgia or long Covid (ACR 2016 criteria and persistent symptoms lasting more than 6 months after a positive RT-PCR test, respectively)
- •Persistent fatigue after an exercise rehabilitation program (FSS score > 36)
- •Physical inactivity, i.e. <150 minutes per week of physical activity
排除标准
- •Pre-existing atrial fibrillation,
- •Left ventricular ejection fraction <40%
- •Severe heart failure
- •Recent stroke or myocardial infarction (<6 months)
- •Unilateral or bilateral vagotomy
- •Pregnancy or breastfeeding
研究组 & 干预措施
Patients with active tVNS
Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.
干预措施: APA program (Other)
Patients with active tVNS
Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.
干预措施: Active transcutaneous VNS (Other)
Patients with sham tVNS
Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.
干预措施: APA program (Other)
Patients with sham tVNS
Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.
干预措施: Sham transcutaneous VNS (Other)
结局指标
主要结局
Fatigue evaluation assessed by autonomic nervous system activity
时间窗: Month : 0; 3
The root mean square of successive differences in heart rate (in milliseconds) will be measured from a nocturnal Holter ECG recording (Novacor, Paris, France) at the end of the 3-month APA and tVNS programme (month 3) and compared with pre-programme values (inclusion).
次要结局
- Medical Outcome Study Short Form questionnaire (MOS-SF 12)(Month : 0; 6)
- Adult Physical Activity Questionnaire (APAQ)(Month : 0; 6)
- Fatigue Severity Scale (FSS)(Month : 0; 6)
- Ratio of Low Frequency to High Frequency (LF/HF)(Month : 0; 6)
- Pittsburgh questionnaire(Month : 0; 6)
- 6-minute walk test (6MWT)(Month : 0; 6)
- Step count per day(Month : 0; 6)