NCT Number: NCT06170645
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Saint-Etienne, 42055, France
Location status: Recruiting
David HUPIN, MD
CONTACT
David HUPIN, MD
PRINCIPAL_INVESTIGATOR
Frédéric ROCHE, MD PhD
CONTACT
Frédéric ROCHE, MD PhD
SUB_INVESTIGATOR
Léonard FEASSON, MD PhD
SUB_INVESTIGATOR
Philippe BOIRON, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month : 0; 6
Physical condition assessed by the walking distance covered in the 6MWT, walking distance in m.
Time frame: Month : 0; 6
Physical activity assessed by the APAQ, time spend to physical activity in hours/day.
Time frame: Month : 0; 6
Objective physical activity assessed by step count per day using a Garmin Vivofit 4 activity tracker.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
David HUPIN, MD
CONTACT
(0)4 77 82 84 13 ext. +33
Hélène RAINGARD, CRA
CONTACT
(0)4 77 12 08 26 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study
Acronym: PAF-tVNS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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