Exercise and Neuromodulation in Fibromyalgia

Official title

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

Overview

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.

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
• 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.

Primary outcome measures

• Changes of the numeric rating scale (0-10) for pain severity [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 outcome measures (12)

• Changes in generalised perception of fatigue [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes in generalised perception of fatigue [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes in generalised perception of fatigue [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes in sleep quality [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes in sleep quality [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes in the level of depression [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes in the level of depression [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes in quality of life [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes in quality of life [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Changes corticospinal excitability [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Adherence to training [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]
• Physical Activity [Time frame: Participants will be assessed at baseline, pre-intervention(T0) and immediately after the four-week intervention (T1).]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Chile · 1 center

• Excercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello — Santiago

Publications

• Kolak E, Ardic F, Findikoglu G. Effects of different types of exercises on pain, quality of life, depression, and body composition in women with fibromyalgia: A three-arm, parallel-group, randomized trial. Arch Rheumatol. 2022 May 7;37(3):444-455. doi: 10.46497/ArchRheumatol.2022.9190. eCollection 2022 Sep. PMID 36589612
• Angius L, Pageaux B, Hopker J, Marcora SM, Mauger AR. Transcranial direct current stimulation improves isometric time to exhaustion of the knee extensors. Neuroscience. 2016 Dec 17;339:363-375. doi: 10.1016/j.neuroscience.2016.10.028. Epub 2016 Oct 14. PMID 27751960
• Martinez-Valdes E, Falla D, Negro F, Mayer F, Farina D. Differential Motor Unit Changes after Endurance or High-Intensity Interval Training. Med Sci Sports Exerc. 2017 Jun;49(6):1126-1136. doi: 10.1249/MSS.0000000000001209. PMID 28121801
• Hooten WM, Smith JM, Eldrige JS, Olsen DA, Mauck WD, Moeschler SM. Pain severity is associated with muscle strength and peak oxygen uptake in adults with fibromyalgia. J Pain Res. 2014 May 3;7:237-42. doi: 10.2147/JPR.S61312. eCollection 2014. PMID 24833914
• Kosek E, Ekholm J, Nordemar R. A comparison of pressure pain thresholds in different tissues and body regions. Long-term reliability of pressure algometry in healthy volunteers. Scand J Rehabil Med. 1993 Sep;25(3):117-24. PMID 8248762
• Ziemann U, Lonnecker S, Steinhoff BJ, Paulus W. Effects of antiepileptic drugs on motor cortex excitability in humans: a transcranial magnetic stimulation study. Ann Neurol. 1996 Sep;40(3):367-78. doi: 10.1002/ana.410400306. PMID 8797526
• Kujirai T, Caramia MD, Rothwell JC, Day BL, Thompson PD, Ferbert A, Wroe S, Asselman P, Marsden CD. Corticocortical inhibition in human motor cortex. J Physiol. 1993 Nov;471:501-19. doi: 10.1113/jphysiol.1993.sp019912. PMID 8120818
• Groppa S, Oliviero A, Eisen A, Quartarone A, Cohen LG, Mall V, Kaelin-Lang A, Mima T, Rossi S, Thickbroom GW, Rossini PM, Ziemann U, Valls-Sole J, Siebner HR. A practical guide to diagnostic transcranial magnetic stimulation: report of an IFCN committee. Clin Neurophysiol. 2012 May;123(5):858-82. doi: 10.1016/j.clinph.2012.01.010. Epub 2012 Feb 19. PMID 22349304

Identifiers

NCT: NCT07323199 · 33B2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗