Effects of a Microdoses Isokinetic Exercise Protocol in Women With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Peak torque
研究概览
简要总结
Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional impairment, which significantly affects quality of life. Physical exercise is considered one of the most effective non-pharmacological interventions for the management of this condition; however, uncertainty remains regarding the most appropriate type, intensity, and frequency of exercise for different patient profiles. The aim of this study is to analyze the effects of a microdoses isokinetic exercise program on physical condition, perceived pain, inflammatory profile and quality of life in women diagnosed with fibromyalgia.
详细描述
Physical exercise is one of the non-pharmacological treatments with the strongest evidence and effectiveness in the management of fibromyalgia, as it has been shown to improve muscle strength and, consequently, patients' quality of life. One of the main limitations in this population is low adherence to traditional exercise programs due to chronic pain. Microdoses exercise training emerges as an alternative approach, based on the principle of the minimum effective dose. To implement this intervention, the training program will be conducted using isokinetic exercise, which allows precise control of movement velocity and joint position to ensure safe conditions. Accordingly, the aim of the present study is to evaluate the effects of an isokinetic exercise microdosing program in women with fibromyalgia over an 8-week intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The person analyzing the data collected (investigators, statisticians) will not know to which group each person belongs.
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
- •Women aged ≥ 18 years diagnosed with fibromyalgia according to current clinical criteria.
- •Clinical and pharmacological stability during the weeks prior to participation in the study.
- •Ability to perform supervised exercise and to complete the assessments.
- •Written informed consent.
排除标准
- •Cardiovascular, neurologic, musculoskeletal or systemic pathology that contraindicate the performance of exercise.
- •Significant change in pharmacological treatment during the period immediately preceding the study.
- •Any condition that, in clinical judgement, prevents them from following the protocol safely.
研究组 & 干预措施
Exercise
An isokinetic exercise program of microdosing will be conducted over 8 weeks, with a frequency of three sessions per week, each lasting 20-25 minutes. Participants will also receive information on healthy lifestyle habits.
干预措施: Exercise (Other)
Control group
Participants assigned to the control group will continue with their usual treatment and will receive general recommendations for healthy lifestyle.
结局指标
主要结局
Peak torque
时间窗: Baseline, up to study completion (8 weeks); week 9
The change in the peak torque (in Nm) will be assessed in the concentric part of a knee extension exercise (1x5) at 60º/s using the Biodex System 4.
Agonist-antagonist ratio
时间窗: Baseline, up to study completion (8 weeks); week 9
The change in the agonist-antagonist ratio (%) of the knee extension exercise will be assessed using the Biodex System 4.
Total work
时间窗: Baseline, up to study completion (8 weeks); week 9.
The change in the total work (in J) of the knee extension exercise will be assessed using the Biodex System 4.
Height
时间窗: Baseline, week 9
The change in the height will be assessed by centimeters (cm).
次要结局
- Muscle electrical activity (amplitude)(Baseline, week 9)
- Muscle electrical activity (frequency)(Baseline, week 9)
- Weight(Baseline, week 9)
- Body composition (Bioimpedance)(Baseline, week 9.)
- Muscle thickness(Baseline, week 9.)
- Pain score(Baseline, up to study completion (8 weeks); week 9.)
- Pain location(Baseline, up to study completion (8 weeks); week 9.)
- Quality of life: Short Form 36 Health Survey(Baseline, week 9.)
- Quality of life: EuroQOL five dimensions questionnaire(Baseline, week 9.)
- Sleep quality(Baseline, week 9.)
- Physical activity levels(Baseline, week 9.)
- Heart rate variability(Baseline, week 9.)
- Interleukin-6 (IL-6) levels(Baseline, week 9.)
- Tumor necrosis factor-alpha (TNF-α) levels(Baseline, week 9.)
- C-reactive protein (CRP) levels(Baseline, week 9.)
- Cortisol(Baseline, week 9.)
- Glucose(Baseline, week 9.)
- Testosterone (total)(Baseline, week 9.)
- Testosterone (free)(Baseline, week 9.)
- Sex hormone-binding globulin(Baseline, week 9.)
- Dehydroepiandrosterone sulfate(Baseline, week 9.)
- Fibromyalgia Impact Questionnaire(Baseline, week 9.)
- Nutritional intake: Consume frequency(Baseline, week 9.)
- Nutritional intake: 24-hour register(Baseline, week 9.)
- Canadian Occupational Performance Measure(Baseline, week 9.)
- Goal Attainment Scaling(Baseline, week 9.)