Fatigue in primary Sjogren's Syndrome Musculoskeletal Diseases
Conditions
Interventions
This is an exploratory pilot study. There will be four visits in total for each participant. A written consent will be signed, the neurocognitive tests will be completed and the participant will be fi
continuous physical activity/”sleep” data and other physiological measures such as
Electrocardiogram (ECG), heart rate (HR), respiratory rate (RR), skin temperature (ST). The participant will be asked to wear the device for 7 days and will be asked to complete a fatigue diary four t
executive functioning and attention (verbal fluency, Str
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Fulfils the American European Consensus Group (AECG) classification criteria for primary Sjögren’s syndrome 3. Willing and able to provide informed written consent and attend clinic for visits
Exclusion criteria
Exclusion criteria: 1. Hospital Anxiety and Depression Score (HADS =11) 2. Fibromyalgia or chronic pain syndromes. 3. History of cerebrovascular diseases, dementia (mini mental state examination score 24), other central nervous system injuries/disorders that impair neurocognitive function 4. A history of severe skin allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured using biosensor data in fatigued and non-fatigued patients: 1. Physical fatigue measured using activity monitors recording; total amount of moderate to vigorous physical activity (daily/weekly), sleep (nighttime rest) efficiency, activity/inactivity bouts (number and duration), mean daily/weekly activity counts. Data collected for two 7 day periods over 8 weeks. 2. Mental fatigue measured using neuropsychological tests; immediate/working memory (Digit span, corsi blocks); executive functioning and attention (verbal fluency, Stroop, Trail Making Test, Vigilance/continuous performance test); psychomotor functions (Digit symbol tests) memory (Rey-Auditory Verbal Learning Test; AVLT). Data collected at visit 1 and visit 3. 3. Patient reported fatigue measured using a patient diary which is completed 4 times daily during the 7 day monitoring period. The Profile of Fatigue (PRO-F), the Multidimensional Fatigue Inventory (MFI) and Cognitive Failures Questionnaire are completed at the end of each monitoring period. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactVictoria Macrae
Outcome results
None listed