About this trial
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.
Eligibility criteria
Qualifiers
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,
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Neuromodulators
Treatment groups
Locations
1Sponsors and collaborators
Universidad Nacional Andres Bello
Lead sponsor