High-Intensity Interval Training (HIIT) and Transcranial Direct Current Stimulation (tDCS) in Women With Fibromyalgia - Effects on Clinical and Neuro-physiological Variables: Randomized Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes of the numeric rating scale (0-10) for pain severity
研究概览
简要总结
Exercise is recommended for people with fibromyalgia because it can reduce symptoms and improve quality of life. Some studies show that high-intensity exercises like running or cycling (also called high-intensity interval training, or HIIT) may reduce symptoms more effectively than slower, traditional exercises.
There are also new treatments, like non-invasive neuromodulation, which uses a gentle current to stimulate brain cells. This technique can help reduce pain in people with fibromyalgia. However, we don't yet know if combining HIIT and neuromodulation works better than exercise alone. We also want to find out if this combination helps improve other symptoms like fatigue and poor sleep.
The goal of this study is to see how a combination of HIIT and neuromodulation affects pain, fatigue, sleep, and muscle strength in women with fibromyalgia.
The investigators are asking two main questions:
Does combining HIIT and neuromodulation reduce pain better than exercise alone? Does this combination improve how the brain controls pain, muscles, and other symptoms like fatigue and sleep problems? What Will the Study Involve?
Three different exercise training programs will be compared:
HIIT with neuromodulation (tDCS): The participant will do HIIT by cycling at a high intensity for 1 minute, then resting for 2 minutes. Then, this will be repeated 10 times. At the same time, the researchers will place two small, damp sponges on the head of the participant. These sponges connect to the tDCS device, which sends a gentle current to your brain. It might feel a tingling sensation at first, but it will fade away.
HIIT with a "sham" (inactive) neuromodulation: This is similar to the first program, but the tDCS device will only be active for a few minutes at the beginning and end of the session.
HIIT alone: This involves just the cycling exercise with no brain stimulation. Who Can Participate?
The researchers are looking for women who:
Are 18-65 years old and have been diagnosed with fibromyalgia Experience moderate to high levels of pain Have stable blood pressure (if they have hypertension) Are not regularly active (don't do more than 30 minutes of exercise at least 3 times per week)
What Will the Study involve?
The participant will:
Attend 6 conditioning sessions (cycling) over two weeks to prepare their body. Complete 4 weeks of HIIT training, three times per week, at Universidad Andres Bello.
Attend 3 assessment sessions in our lab: before the conditioning, before the training, and after the training. These will include:
Non-invasive tests to measure your physical fitness, muscle strength, and pain sensitivity Brain and muscle connection tests. Questionnaires about your sleep, pain, fatigue, anxiety, depression, and exercise enjoyment
What the participant will get?
At the end of the study in addition to the training benefits, participants will receive a detailed report showing their body composition (muscle and fat levels) before and after the training.
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)
盲法说明
Participants from tDCS (active) and sham tDCS (inactive) groups will be blinded to the stimulation.
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 with a diagnosis of Fibromyalgia by a physician according to the criteria of the American College of Rheumatology (ACR) 2016
- •A stable medical treatment for symptoms for at least 4 weeks before participation (stable doses of medication)
- •Reported pain equal to or higher than 40 mm on the visual analogue scale (moderate or severe pain) for more than 3 months
- •Body mass index (BMI) between 18.5 and 39.9 kg m-2,
- •Controlled high blood pressure.
排除标准
- •Isolated inflammatory joint, cancer, infectious, traumatic, localised neuropathic or degenerative joint pain.
- •Intense headache, cerebral surgery, seizure/epilepsy, cardiovascular, lung, metabolic (II diabetes mellitus), retinopathy or neurological diseases (i.e. stroke and traumatic brain injury antecedents),
- •Severe psychiatric disorders, major depression
- •Substance abuse.
- •Currently pregnant/breastfeeding,
- •Under physical therapy treatment or have participated in a designed sports or exercise training in systematic programs in the last 3 months.
- •Unable to speak or read Spanish fluently (inability to understand the pain scale and cooperate in testing)
研究组 & 干预措施
HIGH-INTENSITY INTERVAL TRAINING (HIIT) plus active TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS)
The participants will cycle with a HIGH-INTENSITY INTERVAL TRAINING protocol while being stimulated with active TRANSCRANIAL DIRECT CURRENT STIMULATION for 20 minutes. This intervention will be performed three times per week for four weeks.
HIGH-INTENSITY INTERVAL TRAINING (HIIT) plus sham TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS)
The participants will cycle with a HIGH-INTENSITY INTERVAL TRAINING protocol while being stimulated with sham TRANSCRANIAL DIRECT CURRENT STIMULATION for 20 minutes.
During exercise intervention, to replicate the feeling of current ramping up during active stimulation, the active anode placed on the left M1 will be activated for 30 seconds at the beginning and end of the procedure.
This intervention will be performed three times per week for four weeks.
HIGH-INTENSITY INTERVAL TRAINING (HIIT)
The participants will cycle with a HIGH-INTENSITY INTERVAL TRAINING protocol for 20 minutes without any stimulation.
This intervention will be performed three times per week for four weeks.
结局指标
主要结局
Changes of the numeric rating scale (0-10) for pain severity
时间窗: Participants will be asked to rate their pain sensation at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).
The primary outcome is the auto reported rating of pain severity with a numeric rating scale from 0 to 10 points. Commonly used to assess pain severity, where zero means "no pain" and 10 means "the worst pain imaginable". Participants will be asked to rate their pain sensation before and after the intervention.
次要结局
- Changes corticospinal excitability(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Adherence to training(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Maximal voluntary isometric contraction(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Muscle endurance(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Aerobic capacity(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Pain Sensitivity(Participants will be asked to rate their pain sensation at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Muscle soreness(Participants will be asked to rate their pain sensation at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in the number of painful areas in the body(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in Active Motor Threshold(Participants will be assessed before (T0) and after (T1) the four-week intervention.)
- Changes in Resting Motor Threshold(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in the silence period after the motor evoked potential(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Level of enjoyment of exercise(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Level of muscle soreness(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Level of fear of movement(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in body composition(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in generalised perception of fatigue(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in sleep quality(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in the level of depression(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in quality of life(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Physical Activity(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in anxiety levels(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
- Changes in negative cognitions related to pain(Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).)
研究者
Edith Elgueta Cancino
Associate Professor
Universidad Nacional Andres Bello