Clinical trial NCT04500444: Effects of Aerobic Exercise Training With and Without Blood Flow Restriction in Fibromyalgia
Official title: Effects of Blood Flow Restricted Aerobic Exercise on Pain, Functional Status, Quality of Life, and Hormonal Response to Exercise in Fibromyalgia Patients - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: blood flow restriction training
fibromyalgia
aerobic training
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction, on pain, functional status, quality of life and catecholamine metabolite levels in 24-hour urine in adults with Fibromyalgia.

Detailed description: Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive disorder and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. \[1\]

Fibromyalgia is seen in the society at 2-4%, and the ratio of women to men is 9:1. It is seen most often between the ages of 45 and 60. Neuroendocrine deviations arise with the contribution of central sensitization and / or peripheral pain mechanisms as a result of environmentally related physiological and psychological stresses of people with genetic predisposition.\[2\]

The depletion of biogenic amines in the central nervous system is blamed on the basis of major symptoms such as musculoskeletal pain, muscle fatigue, sleep disturbance, and comorbid chronic depression, anxiety, migraine, which are clinically observed in fibromyalgia. Decreased levels of aminergic neurotransmitters is detected in cerebrospinal fluid (CSF) of fibromyalgia patients, especially serotonin, dopamine, norepinephrine.\[3\]

Studies have found that different exercise programs have positive effects on pain and functionality in fibromyalgia cases, and no side effects of these exercise programs have been observed. Aerobic exercise training is one of the most studied exercise modalities in fibromyalgia patients.\[4\]

However, an increase in post-exercise pain was also found in patients with fibromyalgia due to a decrease in muscle blood flow, defect in muscle contraction physiology and a change in post-exercise pain modulation. In addition, it has been reported that the hormone response given to the exercise is impaired. All of these disorders can decrease patients' compliance to exercise.\[5\]

Exercise with blood flow restriction - Blood Flow Restriction Training (BFRT) - is an increasingly popular exercise modality that creates a physiological effect equivalent to a high exercise intensity when exercising at low exercise intensities. In current studies, although a similar response to high-intensity aerobic exercise was obtained by performing low-intensity blood flow-restricted aerobic exercise training in other patient groups, a recommendation regarding the use of BFRT in a specific disease such as fibromyalgia is lacking.\[6\]

In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction, on pain, functional status, quality of life and catecholamine and melatonin metabolite levels in 24-hour urine in adults with Fibromyalgia.

Eligibility criteria: Inclusion Criteria:

1. Being between 18 and 55 years old
2. Symptoms lasting longer than 3 months
3. According to the 2016 ACR criteria, the Common Pain Scale Score is ≥7 and the Symptom Severity Score is ≥5 or according to the 2016 ACR criteria, the Symptom Severity Score is ≥9 and the Common Pain Scale Score is between 4-6.
4. Fibromyalgia Impact Questionnaire (FIQ) score between 35 and 65 (out of 100)
5. To be able to come to the hospital for treatment 4 days a week for 6 weeks.
6. No change in the medical treatment received due to fibromyalgia syndrome during the study

Exclusion Criteria:

1. Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
2. Peripheral venous insufficiency and coagulopathies
3. Serious cardiovascular pathologies
4. Sensory loss, loss of position sensation, unhealed fracture or open surgical wound
5. Uncontrolled hypertension, diabetes
6. Cognitive disorder causing simple commands difficulty
7. Pregnancy
8. Having entered the menopause

Primary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire (FIQ) score
timeFrame: Baseline, Immediately after the intervention , 3 months after the intervention period
Secondary outcomes:
measure: Change in Central Sensitization Inventory Score
timeFrame: Baseline, Immediately after the intervention , 3 months after the intervention period
measure: Change in Visual Analog Scale for Pain
timeFrame: Baseline, Immediately after the intervention , 3 months after the intervention period
measure: Change in Beck Depression Inventory Score
timeFrame: Baseline, Immediately after the intervention , 3 months after the intervention period
measure: Change in Chronic Pain Acceptance Questionnaire - 8 Score
timeFrame: Baseline, Immediately after the intervention , 3 months after the intervention period
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
Study officials:
affiliation: Professor
name: Ayşegül Ketenci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evcik D, Ketenci A, Sindel D. The Turkish Society of Physical Medicine and Rehabilitation (TSPMR) guideline recommendations for the management of fibromyalgia syndrome. Turk J Phys Med Rehabil. 2019 May 28;65(2):111-123. doi: 10.5606/tftrd.2019.4815. eCollection 2019 Jun.
citation: Hauser W, Ablin J, Fitzcharles MA, Littlejohn G, Luciano JV, Usui C, Walitt B. Fibromyalgia. Nat Rev Dis Primers. 2015 Aug 13;1:15022. doi: 10.1038/nrdp.2015.22.
citation: Singh L, Kaur A, Bhatti MS, Bhatti R. Possible Molecular Mediators Involved and Mechanistic Insight into Fibromyalgia and Associated Co-morbidities. Neurochem Res. 2019 Jul;44(7):1517-1532. doi: 10.1007/s11064-019-02805-5. Epub 2019 Apr 19.
citation: Michiels V, Cluydts R. Neuropsychological functioning in chronic fatigue syndrome: a review. Acta Psychiatr Scand. 2001 Feb;103(2):84-93. doi: 10.1034/j.1600-0447.2001.00017.x.
citation: Bidonde J, Busch AJ, Bath B, Milosavljevic S. Exercise for adults with fibromyalgia: an umbrella systematic review with synthesis of best evidence. Curr Rheumatol Rev. 2014;10(1):45-79. doi: 10.2174/1573403x10666140914155304.
citation: Genc A, Tur BS, Aytur YK, Oztuna D, Erdogan MF. Does aerobic exercise affect the hypothalamic-pituitary-adrenal hormonal response in patients with fibromyalgia syndrome? J Phys Ther Sci. 2015 Jul;27(7):2225-31. doi: 10.1589/jpts.27.2225. Epub 2015 Jul 22.
citation: Patterson SD, Hughes L, Head P, Warmington S, Brandner C. Blood flow restriction training: a novel approach to augment clinical rehabilitation: how to do it. Br J Sports Med. 2017 Dec;51(23):1648-1649. doi: 10.1136/bjsports-2017-097738. Epub 2017 Jun 22. No abstract available.