Supervised walking improves cardiorespiratory fitness, exercise tolerance, and fatigue in women with primary Sjögren’s syndrome: a randomized-controlled trial
The aim of this study was to evaluate the safety and effectiveness of a supervised walking program in women with primary Sjögren’s syndrome (pSS).
Forty-five sedentary women fulfilling the American European Consensus Criteria for pSS were randomized to a training group (TG, n = 23) or control group (CG, n = 22). Patients in the TG were submitted to supervise walking three times a week for 16 weeks. The patients of the CG were instructed to not perform any kind of regular physical exercise. Physical fitness [maximum oxygen uptake (VO2max) and distance], EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI), hematological tests, and Medical Outcomes Study 36 (SF-36) were assessed at baseline and week 16. In addition, EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-fatigue), and Beck Depression Inventory (BDI) were measured prior to intervention, after 8 and 16 weeks. Patient global assessment of response to therapy was completed at the final assessment. An intent-to-treat analysis was performed.
After 16 weeks, the mean change of VO2max (ml/kg/min), distance, and FACIT-fatigue were higher in the TG than in the CG (p = 0.016, p = 0.043 and p = 0.030, respectively). Improved cardiorespiratory fitness was associated with improvements in fatigue scores and physical components of quality of life (SF-36). Furthermore, improved fatigue scores were associated with reduced depression and improvements in the physical and mental components of SF-36. Overall, 95.4% of patients in the TG rated themselves as clinically improved versus 62% of the patients in the CG (p = 0.049). There was no flare in disease activity and no serious adverse events with exercise.
This supervised walking program was demonstrated to be feasible and safe with improvements in cardiorespiratory fitness, exercise tolerance, fatigue, and patient perception of improvement in pSS patients.
Clinical Trials.gov ID, number NCT02370225.
KeywordsSjögren’s syndrome Fatigue Exercise Rehabilitation
Study conception and design: STM, VV, JN, LC, and AJP. Acquisition of data: RAG, LHS, EVS, VCA, and AMS. Data analysis and interpretation: STM, JN, VV, LC, AJP, DL, and WN. Writing: STM, JN, DL, and WN.
All authors have read and approved the manuscript.
This work was supported by grants to Samira Tatiyama Miyamoto from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-CAPES Foundation [BEX 8831/14-9].
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all the participants included in the study.
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