Exercise and Neuromodulation in Fibromyalgia

Summary

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.

Conditions

• Fibromyalgia (FM)

Interventions

OTHER

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

HIIT training: The participants will perform a HIIT protocol that consists of 1 minute of cycling at 50-60 revolutions per minute with a load that generates an effort of 80%-95% of their maximum Heart Rate (HR). Then 2 minutes of passive recovery, all this repeated 10 times (1x2x10). The effort of the session will be monitored by rating the perceived exertion (RPE) with a scale from 6-20 and HR. If the participant fails to recover within 2 minutes (\>70% maximum heart rate), resting time will be extended until an HR ≤ 70% of the maximum is achieved. The maximum HR of each session will be used for HIIT prescription for the next session.

OTHER

Neuromodulators

Active tDCS: Two electrodes covered by a damp sponge will be placed on the scalp. The active electrode (anode) will be placed on the left motor cortex and the cathode on the contralateral supraorbital area before the exercise starts. The stimulation will start at the same time as the exercise, with an intensity of 2mA for 20 minutes.

Sponsors & Collaborators

• Universidad Nacional Andres Bello

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2026-09-30

Completion

2027-06-30

Countries

• Chile

Study Locations