Effects of Aerobic Exercise on Fatigue in Women With Primary Sjögren's Syndrome: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change from baseline in fatigue at 16 weeks
研究概览
简要总结
The purpose of this sudy is to investigate the effects of a regular aerobic exercise on aerobic capacity, fatigue, depression, quality of life, perception of symptoms and disease activity in women with pSS.
详细描述
This study is a randomized controlled trial. 45 women with primary Sjögren's syndrome diagnosed according to the American European Consensus Criteria (VITALI et al, 2002) and age ≤ 65 years-old will be included. Patients, in blocks of four, will be allocated to treatment group (TG) or control group (CG) by simple randomization according to drawing lots.
Treatment group (TG): subjects will be submitted to a supervised walking, 3 times a week for 16 weeks, by one physiotherapist and one physical education student who alternated weekly. The heart rate of the patients will be registered with a pulse watch (Polar® A1, Kempele, Finland) at the beginning, in the intermediate time and at the final of effective walking time. The general exertion was rated on the Borg RPE 0-10 (ratings of perceived exertion) scale in the intermediate time and at the final of effective walking time. Each training session will be preceded by a warm-up period, where patients will be instructed to walk freely and slowly for 5 minutes, followed by 20 to 50 minutes of effective walking when they will be instructed to maintain their paces to achieve the target heart rate and ending by a cold-up period for 5 minutes (similar to warm-up period).
The exercise prescription will be based on the heart rate at the anaerobic threshold determined at the initial assessment according previous studies with patients with fibromyalgia (VALIM et al, 2002; VALIM et al, 2003; ASSIS et al, 2006) and Systemic Lupus Erythematosus (CARVALHO et al, 2005), which demonstrated that ventilatory anaerobic threshold oxygen uptake, although used less than VO2max, is also a good physical fitness indicator, and it has the advantage of not being maximum effort dependent. It seems to be more influenced by training than VO2max and represents a safer intensity for exercise, thus decreasing the risk of lesions and constituting an important measure for prescription of exercise. As there is no previous studies using spiroergometric test in pSS and fatigue is very similar to fibromyalgia and lupus patients, we believe pSS performance in treadmill test and training is probably the same. The increment of intensity exercise will be based on time: 30 in the first 2 weeks, adding 5 minutes per week until eighth week, completing 60 minutes, which remains until the end.
Control group (CG): subjects randomized to control group will not participate of the walking exercise initially, but after completing 16 weeks they will be invited to participate of the training group.
Clinical outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female gender and age ≤ 65 years-old
- •pSS diagnosed according to the American European Consensus Criteria (VITALI et al, 2002)
- •corporal mass index < 40.
排除标准
- •use of beta-blocker therapy;
- •severe manifestations on pulmonary, renal, neurologic or musculoskeletal system (from the disease or not);
- •limiting or hindering their ability to walking performance
- •those who had performed regular physical activity in the 6 weeks before trial.
结局指标
主要结局
Change from baseline in fatigue at 16 weeks
时间窗: baseline and 16 weeks
questionnaires: Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-Fatigue) (WEBSTER et al, 1999; WEBSTER et al, 2003)
次要结局
- Change from baseline in aerobic capacity at 16 weeks(baseline and 16 weeks)
- Change from baseline in depression at 8 weeks(baseline and 8 weeks)
- Change from baseline in depression at 16 weeks(baseline and 16 weeks)
- Change from baseline in disease activity at 16 weeks(baseline and 16 weeks)
- Change from baseline in quality of life at 16 weeks(baseline and 16 weeks)
- Change from baseline in symptoms at 8 weeks(baseline and 8 weeks)
- Change from baseline in symptoms at 16 weeks(baseline and 16 weeks)
研究者
Samira Tatiyama Miyamoto, PhD
Prof MSc
Federal University of Espirito Santo