Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies

FACIT-F score in the different groups

FACIT-F score at 48 weeks, in the different groups

Time frame: between inclusion (Week 0) and week 48

Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)

Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds), measured from a nocturnal ECG recording by Holter ECG, in the different groups

Time frame: at 12, 24 and 48 weeks,

Proportion (in %) of the 24 APA sessions carried out (at least 80% of the exercises proposed) in the different groups

Time frame: week 48

ClinESSDAI score

ClinESSDAI score (clinical part of the EULAR Sjögren's Syndrome Disease Activity Index; assessed on 11 "domains" corresponding to the main clinical manifestations of the disease; ranging from 0 to 135, a score of 0 meaning the existence of a disease and a score of 135 a disease whose activity would be maximal) in the different groups

Time frame: at 12, 24 and 48 weeks,

ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)

ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index); calculated as the mean of 3 self-measurement scales assessing fatigue, dryness and pain, each ranging from 0 to 10; 0 meaning the total absence of the symptom considered and 10 a symptom whose intensity would be at the maximum imaginable) in the different groups

Time frame: at 12, 24 and 48 weeks

HADS questionnaire (Hospital Anxiety and Depression Scale)

HADS questionnaire (Hospital Anxiety and Depression Scale) composed of an anxiety score and a depression score both ranging from 0 to 21, 0 meaning the absence of symptoms of this type, and 21 the presence of an anxiety and/or major depressive state) in the different groups

Time frame: at 12, 24 and 48 weeks

Self-measurement questionnaire SF-36 (Short Form Health Survey 36)

Self-measurement questionnaire SF-36 (Short Form Health Survey 36); comprising 36 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite)

Time frame: between inclusion (Week 0) and week 48

EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health

EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health (mobility, autonomy, daily activities, pain/discomfort and anxiety/depression) with 1 question per domain, with the possibility of choosing 5 degrees of severity each time (1 corresponding to no difficulty for the domain and 5 corresponding to the maximum degree of difficulty in the domain), the total of the 5 notes of the 5 domains giving a score ranging from 5 to 25, and this questionnaire is associated with a visual analogue scale (VAS) allowing the patient to rate his state of health of the day from 0 (the worst state of health imaginable) to 100 (the best state of health imaginable), in the different groups

Time frame: at 12, 24, and 48 weeks,

Schirmer test

the area of the graduated blotter that became wet after 5 min of placement on the lower eyelid of each eye, expressed in millimeters and as the average of the two eyes) at 12, 24 and 48 weeks, in the different groups

Time frame: at 12, 24 and 48 weeks

VO2max

VO2max (in ml/min/kg; after metabolic test) in the different groups

Time frame: at 12, 24 and 48 weeks

Handgrip test

Handgrip test (in kg; via a grip test on the dominant upper limb) in the different groups

Time frame: at 12, 24 and 48 weeks

Number of daily steps

Number of daily steps measured via a connected watch on average over the week preceding the assessments at 12, 24 and 48 weeks, in the different groups

Time frame: at 12, 24 and 48 weeks