Samira Tatiyama Miyamoto1,2, Valéria Valim3,4, Luciana Carletti5, Wan-Fai Ng6, Anselmo José Perez5, Dennis William Lendrem6, Michael Trennel7, Raquel Altoé Giovelli3, Laiza Hombre Dias3, Érica Vieira Serrano3, Alice Mendonça Subtil5, Vanessa Cândido Abreu5, Jamil Natour8. 1. Department of Integrated Education in Health, Universidade Federal do Espírito Santo, Av. Maruípe, 1468, Vitoria, ES, 29040-090, Brazil. 2. Department of Rheumatology, Universidade Federal de São Paulo-Escola Paulista de Medicina, Rua Botucatu, 740, São Paulo, SP, 04023-900, Brazil. 3. Rheumatology Outpatient Clinic-Hospital Universitário Cassiano Antônio de Moares (HUCAM), Universidade Federal do Espírito Santo, Av. Marechal Campos, 1355, 29043-260, Vitoria, ES, Brazil. 4. Department of Medical Clinic, Universidade Federal do Espírito Santo, Av. Marechal Campos, 1468, Vitoria, ES, 29040-090, Brazil. 5. Exercise Physiology Laboratory (LAFEX), Universidade Federal do Espírito Santo, Av. Fernando Ferrari, 514, Vitoria, ES, 29075-810, Brazil. 6. Musculoskeletal Research Group, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK. 7. MoveLab, Physical Activity and Exercise Research, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK. 8. Department of Rheumatology, Universidade Federal de São Paulo-Escola Paulista de Medicina, Rua Botucatu, 740, São Paulo, SP, 04023-900, Brazil. jnatour@unifesp.br.
Abstract
OBJECTIVE: 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). METHODS: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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Clinical Trials.gov ID, number NCT02370225.
RCT Entities:
OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 pSSpatients. TRIAL REGISTRATION: Clinical Trials.gov ID, number NCT02370225.
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