EXERCISE CAPACITY IN PRIMARY SJÖGREN’S SYNDROME
Research type
Research Study
Full title
EXERCISE (AEROBIC) CAPACITY IN PRIMARY SJÖGREN’S SYNDROME
IRAS ID
168303
Contact name
Samira T. Miyamoto
Contact email
Sponsor organisation
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
The aim of the study is to evaluate the relationship between age, body mass index (BMI), exercise capacity, level of physical activity, patient’s symptoms, anxiety, depression, quality of life, disease activity and cytokines (proteins secreted by cells of the immune system) on the fatigue on British women with primary Sjogren's syndrome (pSS) comparing to healthy controls. Thirty two participants will be allocated in each group, same as a similar study that has been conducted by the proposed visiting student from Brazil as part of her PhD study. Data from this UK study will be used to compare the results of the Brazilian cohort. Exercise capacity will be evaluated by spiroergometric test (exercise test on treadmill), level of physical activity by International Physical Activity Questionnaire (IPAQ)-short form, fatigue and pSS patient’s symptoms by FACIT-Fatigue, European Sjogren's syndrome patient reported index (ESSPRI) and Profile of Fatigue, anxiety and depression by Hospital Anxiety and Depression scale (HADS)and Beck Depression Inventory, health-related quality of life by Short form-36 items (SF-36), disease activity by European Sjogren's syndrome disease activity index (ESSDAI) and cytokines levels. Group comparisons, correlations between the variables and investigation about which variable has influence on fatigue will be made using adequate statistic tests. The expectation is that exercise capacity in women with pSS is lower than healthy women and this variable, or others, is associated to fatigue in pSS.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
15/YH/0329
Date of REC Opinion
30 Jul 2015
REC opinion
Unfavourable Opinion