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.
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)
Pre-existing atrial fibrillation,
Left ventricular ejection fraction <40%
Severe heart failure
Recent stroke or myocardial infarction (<6 months)
Parallel
APA program
Other interventionAn APA program of 12 weeks, 2 sessions of 1h/week for mixed endurance, strengthening and stretching work. The program can be realized at home or in structure.
Active transcutaneous VNS
Other interventionAfter each APA session, a 1h-tVNS session is delivered on the conchae aurea of the left ear, in resting condition. Parameters of tVNS : frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.
Sham transcutaneous VNS
Other interventionAfter each APA session, a 1h-tVNS session is delivered on the left earlobe, in resting condition. Parameters of tVNS : frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.
Fatigue evaluation assessed by autonomic nervous system activity
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).
Fatigue Severity Scale (FSS)
Subjective fatigue assessed by FSS, score from 9 to 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.
Medical Outcome Study Short Form questionnaire (MOS-SF 12)
Quality of life assessed by the MOS-SF 12 questionnaire , score from 0 to 100. A low score reflects a perception of poor health, loss of function and the presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain.
Pittsburgh questionnaire
Quality of sleep assessed by Pittsburgh questionnaire (score 0 to 21). The 7 components of the score add up to give an overall score ranging from give an overall score ranging from 0 to 21 points, with 0 meaning that there are no difficulties, and 21 indicating major difficulties.
6-minute walk test (6MWT)
Physical condition assessed by the walking distance covered in the 6MWT, walking distance in m.
Click on the lead sponsor to view all of their trials.
