Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training: Clinical Trial Randomized Crossover
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Choose one of the workouts according to your preference
研究概览
简要总结
Fibromyalgia is a painful syndrome of unknown etiology, which affects 2% of world population, with symptoms such as: pain, unrefreshing sleep, fatigue and mood disorders. It is already established in the literature that resistance training is part of the non- pharmacological treatment for patients with fibromyalgia. The big gap is about the quantity adequate and/or recommended exercise volume, despite some studies with exercise volumes different resistance trainings show improvements, we do not have a direction, besides We still do not know whether there is a preference for these patients in different resistance training volumes.
详细描述
Objective
Assess training volume preference resisted in women with fibromyalgia.
Method: Crossover randomized clinical trial, randomized and blind. 36 women with fibromyalgia will be evaluated, who will undergo three resistance training programs with different training volumes. The primary outcome will be patient preference in relation to training volumes, and the secondary ones will be the patient expectation, pain intensity, affect and subjective perception of exertion.
Analysis statistics: For the primary outcome preference, the number of choices will be counted of the 3 types of training in percentage form. Regarding the analysis of the primary outcome we will summarize the patient's preference in a contingency table, we will compare the proportions using the Chi-square test, and finally we will check the effect size of the observed differences. For secondary outcomes, statistical analyzes will be performed by a blind statistician using commercial software. The Kolmogorov-Smirnov test will be applied to verify the distribution of data and Levene's test will be used to analyze the homogeneity of variance. The Bonferroni test will be used in post hoc analyzes to determine whether there are differences between the groups at different intervention times. One 5% significance level and 95% CI will be adopted for all statistical analyses. ethic and dissemination: The results of the study will be disseminated to participants and subjected to a peer-reviewed journal and scientific meetings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- •Women aged 18 to 65
- •Have a diagnosis of fibromyalgia according to the ACR 2016 criteria
排除标准
- •Have performed resistance training in the last 6 months
- •Having another associated rheumatic condition
- •Have a trip or appointment scheduled that requires absence for the next 4 (four) weeks from the start of the survey;
- •Women with musculoskeletal injuries in the upper and/or lower limbs
- •Have heart problems that prevent maximal efforts and submaximums
结局指标
主要结局
Choose one of the workouts according to your preference
时间窗: 28 day
Preference will be assessed through the following question: "After carrying out the training sessions, which one did you prefer? Why?".
次要结局
- Change in Affection(baseline, 28 day)
- Change in Subjective perception of exertion(baseline, 28 day)
- Change in Expectation(baseline)
- Change in Pain intensity(baseline, 28 day)
研究者
Marcelo Cardoso de Souza, PT, PhD.
Principal Investigator and Professor of Department of Physiotherapy
Universidade Federal do Rio Grande do Norte