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临床试验/NCT06243562
NCT06243562尚未招募不适用

The Effects Of Progressive Muscle Relaxation Training in Addition to the Combined Exercise Training in Women With Fibromyalgia

Abant Izzet Baysal University2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2024年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
试验地点
2
主要终点
The Pain Catastrophizing Scale

研究概览

简要总结

The purpose of the study is to examine the effects of progressive muscle relaxation training given in addition to a combined exercise program in women with fibromyalgia.

详细描述

Fibromyalgia syndrome is a complex, non-inflammatory pain syndrome characterized by whole-body pain, pain at specific tender points, fatigue, and sleep disturbance

The prevalence of fibromyalgia in the world population varies between 0.2% and 6.4%, and it more frequently affects middle-aged women (30-50 years old). the etiology of fibromyalgia is not fully known.

There are no generally accepted objective clinical findings, radiographic abnormalities, or laboratory tests to assess the presence of fibromyalgia and measure fibromyalgia severity. Therefore, questionnaires measuring patients' subjective responses remain important in the evaluation of fibromyalgia patients until now.

Current treatment recommendations for fibromyalgia strongly support a multifaceted regimen, including patient education, physical therapy, massage, cognitive behavioral therapy, specific pharmacotherapy, restorative sleep, and exercise. Exercise includes aerobic exercise, strengthening and stretching.

Progressive muscle relaxation therapy is an alternative complementary therapy based on the principle of progressive tensing and relaxing of major body muscles to relieve psychological tension. The therapy has no time or space restrictions and does not require any special equipment.

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
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with fibromyalgia over the age of 20
  • volunteering to participate in the study.

排除标准

  • neurological, infectious, endocrine and/or other inflammatory rheumatic diseases
  • serious psychiatric illness (schizophrenia, etc.)
  • any condition that prevents exercise (advanced heart, respiratory or orthopedic problems)
  • Malignancy
  • pregnancy
  • menopause
  • Participating in a physical therapy program (receiving exercise / relaxation training) in the last 6 months

研究组 & 干预措施

combined exercises and progressive muscle relaxation group

Active Comparator

Participants in this group will be given combined exercises consisting of aerobic exercise, strengthening exercise and stretching exercise, as well as progressive muscle relaxation training. The studies will be carried out under the supervision of a physiotherapist.

干预措施: combined exercises and progressive muscle relaxation group (Other)

combined exercises group

Active Comparator

Participants in this group will be given combined exercises consisting of aerobic exercise, strengthening exercise and stretching exercise. They will rest for 10-15 minutes in a relaxation position only. The studies will be carried out under the supervision of a physiotherapist.

干预措施: combined exercises group (Other)

结局指标

主要结局

The Pain Catastrophizing Scale

时间窗: Eight weeks

The Pain Catastrophizing Scale is a self-report measure of pain-related catastrophizing thinking. It consists of 13 items on a five-point Likert scale (0 = never to 4 = always ). The total score ranges from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.

Visual Analog Scale

时间窗: Eight weeks

The Visual Analog Scale measures pain intensity. It consists of a 10 cm line with two end points representing 0 (no pain) to 10 (pain as bad as possible). The patient marks the current pain level by placing a mark on the line.

次要结局

  • COMPASS 31 Scale:(Eight weeks)
  • Blood Pressure(Eight weeks)
  • The Respiratory Frequency(Eight weeks)
  • Grip Strength(Eight weeks)
  • The Fibromyalgia Impact Scale(Eight weeks)
  • Skin Temperature(Eight weeks)
  • Pulse(Eight weeks)
  • Pittsburgh Sleep Quality Index(Eight weeks)
  • The Fatigue Severity Scale(Eight weeks)
  • Saturation(Eight weeks)
  • Sit and Reach Test(Eight weeks)
  • 6-Minute Walk Test(Eight weeks)
  • Perceived Stress Scale(eight weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eylem TÜTÜN YÜMİN

Professor

Abant Izzet Baysal University

研究点 (2)

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