跳至主要内容
临床试验/NCT02063750
NCT02063750已完成4 期

Effectiveness of Strengthening Exercises Using the Swiss Ball for Patients With Fibromyalgia: a Randomized Controlled Trial

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Changes in Pain - VAS

研究概览

简要总结

Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM).

Material and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching group (SG), in which patients performed stretching exercises. All patients participated in 40-minute training sessions three times per week for 12 weeks. The IG performed the following eight strengthening exercises using a Swiss ball: lateral rise, simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The assessor was blind to patient allocation.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female with fibromyalgia according to the classification criteria of the American College of Rheumatology;
  • aged between 20 and 65 years old.

排除标准

  • uncontrolled hypertension;
  • decompensated cardiac disease;
  • history of syncope or exercise-induced arrhythmias and decompensated diabetes;
  • severe psychiatric illness;
  • history of regular exercise at least twice a week for the last 6 months;
  • any other condition that could prevent the patient from performing physical exercises.

结局指标

主要结局

Changes in Pain - VAS

时间窗: Basline, after 6 and 12 weeks

次要结局

  • Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire(Baseline, after 6 and 12 weeks)
  • Changes in muscle strength using the maximum repetition (1 RM)(Baseline, after 6 and 12 weeks)
  • Changes in consumption of analgesics(After 6 and 12 weeks from baseline)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamil Natour

Head of Rheumatology Division

Federal University of São Paulo

研究点 (2)

Loading locations...

相似试验