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
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Fibromyalgia Impact Questionnaire (FIQ) score
研究概览
简要总结
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.
详细描述
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]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being between 18 and 55 years old
- •Symptoms lasting longer than 3 months
- •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-
- •Fibromyalgia Impact Questionnaire (FIQ) score between 35 and 65 (out of 100)
- •To be able to come to the hospital for treatment 4 days a week for 6 weeks.
- •No change in the medical treatment received due to fibromyalgia syndrome during the study
排除标准
- •Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
- •Peripheral venous insufficiency and coagulopathies
- •Serious cardiovascular pathologies
- •Sensory loss, loss of position sensation, unhealed fracture or open surgical wound
- •Uncontrolled hypertension, diabetes
- •Cognitive disorder causing simple commands difficulty
- •Having entered the menopause
研究组 & 干预措施
Blood-Flow Restriction Group
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.
干预措施: exercise training (Other)
Control Group
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.
干预措施: exercise training (Other)
结局指标
主要结局
Change in Fibromyalgia Impact Questionnaire (FIQ) score
时间窗: Baseline, Immediately after the intervention , 3 months after the intervention period
The Fibromyalgia Impact Questionnaire (FIQ) was developed by clinicians at the Oregon Health Sciences University in the late 1980s to capture and evaluate the total spectrum of fibromyalgia-related problems and response to treatment. It was first used in 1991 and is still an indicator of therapeutic effectiveness today. it is used frequently. It consists of 10 questions to measure physical, emotional, cognitive and motivational symptoms such as physical disability, pain, fatigue, joint stiffness, depression and anxiety in fibromyalgia. Each question has been scored within itself. The total score will be between 0-100. 100 points indicate the highest exposure to the disease.
次要结局
- Change in Visual Analog Scale for Pain(Baseline, Immediately after the intervention , 3 months after the intervention period)
- Change in Chronic Pain Acceptance Questionnaire - 8 Score(Baseline, Immediately after the intervention , 3 months after the intervention period)
- Change in Beck Depression Inventory Score(Baseline, Immediately after the intervention , 3 months after the intervention period)
- Change in Central Sensitization Inventory Score(Baseline, Immediately after the intervention , 3 months after the intervention period)
研究者
Mert Zure
Medical Doctor
Istanbul University