Effects of Aerobic Exercise Training With and Without Blood Flow Restriction in Fibromyalgia

Istanbul University

Status: Unknown

Conditions: Fibromyalgia

Treatments: Other: exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT04500444

1301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Blood-Flow Restriction Group

Experimental group

Description:

An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. The blood flow restriction protocol will be applied to both lower extremities at the crotch level with 10 cm wide elastic bandages before warming up. Before the first application, patients will be evaluated by a specialist physician using ultrasonography and it will be ensured that the arterial blood flow is not restricted as the blood flow restriction restricts only venous blood flow. The pressure threshold at this point is the level to be used in subsequent training sessions and the same person (physician) will be bandaging in the same way during all subsequent training sessions.

Treatment:

Other: exercise training

Control Group

Sham Comparator group

Description:

An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. The sham blood flow restriction protocol will be applied which consists of loose bandaging to both lower extremities at the crotch level with 10 cm wide elastic bandages before warming up. The same person (physician) will be bandaging in the same way during all subsequent training sessions. The pressure feeling of the patient must correspond to level 0 -not tight at all- before starting the exercise training.

Treatment:

Other: exercise training