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临床试验/NCT06277596
NCT06277596招募中不适用

Comparison of the Effects of Progressive Clinical Pilates Exercises Applied as a Supervised and Home Program in Individuals With Fibromyalgia

Eastern Mediterranean University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
Visual Analog Scale ( VAS )

研究概览

简要总结

The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50.

详细描述

After the voluntary individuals with Fibromyalgia (FM) who meet the inclusion criteria are evaluated, they will be randomly divided into two groups: exercise group and home exercise group.

The same clinical Pilates program will be applied to both groups at the same dosage. Evaluations and treatment will be applied to both groups by the same physiotherapist. Individuals will perform the exercises 10 repetitions, 3 days a week, for 6 weeks. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. For the home exercise group, all exercises will be shown and it will be ensured that they are performed correctly. Patients will be given an illustrated and descriptive exercise program brochure containing information about exercise position, number of repetitions, contraction duration, rest time between sets, frequency, and an exercise diary for exercise tracking.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteer individuals between the ages of 20-50
  • Diagnosed with fibromyalgia according to the American College of Rheumatology criteria
  • Pain level 3 and above according to visual analogue scale.
  • Individuals who are sedentary (who have not engaged in physical activity at least 3 days a week in the last 3 months) will be included in the study.

排除标准

  • Having additional rheumatic disease
  • Using NSAIDs and antidepressant drugs
  • Individuals with orthopedic, neurological and cardiopulmonary diseases that prevent them from exercising
  • Pregnant women
  • Malignancy
  • Individuals with uncontrolled systemic diseases (diabetes, systemic arterial hypertension, thyroid dysfunction, neurological, cardiorespiratory, musculoskeletal problems, etc.)

结局指标

主要结局

Visual Analog Scale ( VAS )

时间窗: 6 weeks

Pain during activities of daily living and at rest will be evaluated with the Visual Analogue Scale (VAS). The individual will be asked to mark the appropriate point on a 10-centimeter (cm) horizontal line between 0 (no pain) and 10 (unbearable pain) at both ends. The distance between the point marked by the individual and the start will be measured with a ruler in cm and recorded. A 2-point reduction in VAS is considered a clinically important improvement.

次要结局

  • Fear-Avoidance Beliefs Questionnaire(6 weeks)
  • Pain Self-Efficacy Questionnaire(6 weeks)
  • Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ)(6 weeks)
  • Sociodemographic information (weight)(6 weeks)
  • Pittsburgh Sleep Quality Index(6 weeks)
  • Treatment Satisfaction Evaluation(6 weeks)
  • Chair Sit to stand test(6 weeks)
  • Fatigue Severity Scale(6 weeks)
  • Sociodemographic information (age)(6 weeks)
  • Sociodemographic information (height)(6 weeks)
  • Trunk Muscle Endurance (McGill Endurance Test and Plank Test)(6 weeks)
  • 6 minute walk test(6 weeks)
  • Revised Fibromyalgia Impact Questionnaire(6 weeks)
  • Body Awareness Questionnaire(6 weeks)
  • Short form-36 (SF-36)(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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