Exercise and Neuromodulation in Fibromyalgia

Universidad Nacional Andres Bello

Status: Not yet enrolling

Conditions: Fibromyalgia (FM)

Treatments: Other: Neuromodulators; Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Study type: Interventional

Funder types: Other

Identifiers

NCT07323199

33B2024

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

HIGH-INTENSITY INTERVAL TRAINING (HIIT) plus active TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS)

Experimental group

Description:

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.

Treatment:

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Other: Neuromodulators

HIGH-INTENSITY INTERVAL TRAINING (HIIT) plus sham TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS)

Sham Comparator group

Description:

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.

Treatment:

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Other: Neuromodulators

HIGH-INTENSITY INTERVAL TRAINING (HIIT)

Active Comparator group

Description:

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.

Treatment:

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION