Chronic Fatigue Syndrome
Conditions
Keywords
Chronic fatigue, Transcutaneous vagal nerve stimulation (tVNS), adapted physical activity (APA)
Brief summary
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.
Interventions
OTHERAPA program
An 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.
OTHERActive transcutaneous VNS
After 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.
OTHERSham transcutaneous VNS
After 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.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue evaluation assessed by autonomic nervous system activity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale (FSS) | Month : 0; 6 | 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) | Month : 0; 6 | 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 | Month : 0; 6 | 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) | Month : 0; 6 | Physical condition assessed by the walking distance covered in the 6MWT, walking distance in m. |
| Adult Physical Activity Questionnaire (APAQ) | Month : 0; 6 | Physical activity assessed by the APAQ, time spend to physical activity in hours/day. |
| Step count per day | Month : 0; 6 | Objective physical activity assessed by step count per day using a Garmin Vivofit 4 activity tracker. |
| Ratio of Low Frequency to High Frequency (LF/HF) | Month : 0; 6 | The autonomic balance (sympathetic/parasympathetic) will be analysed by measuring the LF/HF ratio on the basis of a nocturnal Holter ECG recording (Novacor, Paris, France). |
Countries
France
Contacts
CONTACTDavid HUPIN, MD
CONTACTHélène RAINGARD, CRA
PRINCIPAL_INVESTIGATORDavid HUPIN, MD
Centre Hospitalier Universitaire de Saint Etienne
Outcome results
None listed