Exercise and Neuromodulation in Fibromyalgia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversidad Nacional Andres Bello

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • EXERCISE TRAINING WITH OR WITHOUT MEDICATION

    Other intervention

    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.

  • Neuromodulators

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: HIGH-INTENSITY INTERVAL TRAINING (HIIT) plus active TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS)Experimental treatment 2 interventions
Group B: HIGH-INTENSITY INTERVAL TRAINING (HIIT) plus sham TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS)Sham comparator 2 interventions
Group C: HIGH-INTENSITY INTERVAL TRAINING (HIIT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes of the numeric rating scale (0-10) for pain severity

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.

Time frame
Participants will be asked to rate their pain sensation at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).

Secondary outcomes

1

Changes in generalised perception of fatigue

Generalised Fatigue: "is a profound and overwhelming, more severe, constant, and unpredictable than normal tiredness, not relieved by resting or sleep, not proportional to effort exerted, and disruptive in terms of motivation, activities, and cognition". The generalised fatigue will be assessed with: Multidimensional Fatigue Inventory (MFI). A questionnaire with 20 items divided into 5 domains: general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation. The score range is between 4 to 20 points; a higher score indicates a greater degree of fatigue.

Time frame
Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).
2

Changes in generalised perception of fatigue

The Symptom Severity (SS) Score, a tool that measures the severity of symptoms like fatigue, unrefreshed sleep, and cognitive issues, along with other somatic symptoms, over the past week. Rating the severity from 0 (no problem) to 3 (severe).

Time frame
Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).
3

Changes in generalised perception of fatigue

Fibromyalgia Impact Questionnaire (FIQR): The sub-item evaluates fatigue with a rating scale of 11 blocks (0 to 10). Higher scores indicate no energy.

Time frame
Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).
4

Changes in sleep quality

The sleep quality will be measured with: Numeric Rating Scale (0-10): single-item tool that instructs the patient to describe the quality of sleep during the past 24 hours, where 0 is the best possible sleep and 10 is the worst possible sleep.

Time frame
Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).

Other outcomes

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