Effects of High-Intensity Versus Preferred-Intensity Resistance Training in the Treatment of Women With Fibromyalgia: A Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Severity and impact of fibromyalgia
研究概览
简要总结
This randomized crossover clinical trial aims to verify and compare the effects of high-intensity (HIG) and preferred-intensity (PIG) resistance training on the health of women with fibromyalgia (FM). Secondary objectives include verifying differences after 4, 8, and 16 sessions, as well as evaluating the proportion of participants who achieve the minimal clinically important difference in the disease impact/severity outcome.
Patients included in the study will be randomized into two groups: HIG and PIG. Sixteen training sessions will be conducted twice a week, with each session lasting approximately 60 minutes. Subsequently, patients will undergo a minimum 8-week washout period (detraining) and will then be allocated to the other intervention group.
The primary outcome is disease impact evaluated using the Revised Fibromyalgia Impact Questionnaire (FIQR). Secondary outcomes include mood states evaluated by the Brunel Mood Scale (BRUMS), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), anxiety levels evaluated with the Beck Anxiety Inventory (BAI), and depression levels evaluated with the Beck Depression Inventory (BDI). Attendance and absence data will also be collected, as well as information regarding program discontinuation.
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
- None
盲法说明
Although blinding is not fully possible, several measures were taken to minimize bias: evaluators conduct the baseline assessments in an interview format, while all subsequent assessments are self-administered by the participants. Patients are aware they are participating in resistance training, but are blinded to the different intensity conditions. Additionally, the investigator responsible for randomization is not directly involved in the intervention delivery or outcome evaluations.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed informed consent to participate in the study.
- •Female participants aged 18 years or older.
- •Confirmed clinical diagnosis of fibromyalgia documented by a medical report.
- •Not currently participating in any regular physical activity involving strength or resistance training.
排除标准
- •Presence of physical or cognitive conditions that impair the execution of the prescribed exercises.
- •Pregnancy.
- •Medical contraindication to physical exercise.
- •Engagement in physical activities such as resistance training, Pilates, swimming, calisthenics, yoga, or martial arts.
结局指标
主要结局
Severity and impact of fibromyalgia
时间窗: Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions)
The Revised Fibromyalgia Impact Questionnaire (FIQR) evaluates the impact of fibromyalgia on patients' quality of life over the preceding 7 days (Lupi et al., 2017). The instrument assesses symptoms and daily difficulties using a 0-to-10 numerical rating scale, where higher scores indicate greater disease impact. The 21-item questionnaire yields a total score ranging from 0 to 100, composed of three subscales: Function (0-30), Overall Impact (0-20), and Symptoms (0-50). Total scores can also be classified into severity categories: 0-23 (remission), 24-40 (mild), 41-63 (moderate), 64-82 (severe), and ≥ 83 (very severe) (Salaffi et al., 2021).
次要结局
- Mood States (BRUMS)(Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions))
- Sleep Quality (PSQI)(Baseline, 4 weeks (8 sessions), and 8 weeks (after 16 sessions))
- Anxiety Levels (BAI)(Baseline, 2 weeks (4 sessions), 4 weeks (8 sessions), and 8 weeks (after 16 sessions))
- Depression Levels (BDI)(Baseline, and 8 weeks (after 16 sessions))
研究者
Loiane Cristina de Souza
Researcher and Doctoral Student
University of the State of Santa Catarina