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临床试验/NCT02716844
NCT02716844已完成不适用

The Effect Of The Clinical Pilates Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis

Eastern Mediterranean University0 个研究点目标入组 47 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
主要终点
Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks

研究概览

简要总结

Aim: Investigating the effects of Clinical Pilates Exercise on kinesiophobia, pain, functional status and quality of life of the patients diagnosed with osteoporosis.

Method: 47 patients were assessed and randomly divided into 2 groups. Exercise group patients joined exercise program regularly that was held 3 times a week, 1 hour a day, during 6 weeks with physiotherapist. Control group patients continued their normal daily lives without any exercise. After 7 patients quit the study for various reasons, 40 women with primary osteoporosis (control group n=20, exercise group n= 20), completed the study and were assessed at the beginning and at the end of 6 weeks. As assesment' measurements Tampa Kinesiophobia Scale (TKS), Visual Analog Scale (VAS), Short Form McGill (SF-McGill), Pain Disability Index (PDI), Oswestry Disability Index (ODI), Berg Balance Test (BBT), Timed Up- Go Test (TUG), Chair Sit-Stand Test (CSST), Chair Sit and Reach Test (CSRT), Back Scratch Test (BST), Quality of life Questionnaire European Foundation for Osteoporosis (QUALEFFO-41), Hospital Anxiety and Depression Scale (HADS), Satisfaction with Life Scale (SLS) and Health Assesment Questionnaire (HAQ) were performed.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman diagnosed with osteoporosis between the ages 50-75 within the last year
  • Exclusion Criteria
  • History of fractures
  • Joint replacements or fixation of the joints at the lower extremities or the spine
  • Any neurological or muscle diseases
  • Inability to continuously attend the exercise program
  • Any secondary diseases resulting in decreased mobility or functional status
  • Visual, hearing or mental problems that could prevent communication

排除标准

  • 未提供

结局指标

主要结局

Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks

时间窗: At the beginning and at the end of 6 weeks

40 osteoporosis patients filled Tampa Kinesiophobia Scale at the beginning and at the end of 6 weeks in order to measure the level of fear and avoidance associated with movement. If an individual receives a high score, according to the scale, this result indicates a high level of kinesiophobia . It has not a specific unit. There is not an adverse events in this test.

次要结局

  • Change in the level of pain intensity at rest assessed using Visual Analogue Scale (VAS) at 6 weeks.(At the beginning and at the end of 6 weeks)
  • Change in the level of pain intensity in the morning assessed using Visual Analogue Scale (VAS) at 6 weeks.(At the beginning and at the end of 6 weeks)
  • Change in the level of pain intensity during activity assessed using Visual Analogue Scale (VAS) at 6 weeks.(At the beginning and at the end of 6 weeks)
  • Change in the level of influence of patients' general pain intensity on their daily life activities and functionality assessed using Pain Disability Index (PDI).(At the beginning and at the end of 6 weeks)
  • Change in the level of quality of life assessed using Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) at 6 weeks(At the beginning and at the end of 6 weeks)
  • Change in the level of life satisfaction assessed using Satisfaction with Life Scale (SLS) at 6 weeks(At the beginning and at the end of 6 weeks)
  • Change in the level of functional balance assessed using Berg Balance Test (BBT).(At the beginning and at the end of 6 weeks)
  • Change in the level of lower extremity proximal muscle's strength and endurance assessed using Chair Sit and Stand Test (CSST) at 6 weeks.(At the beginning and at the end of 6 weeks)
  • Change in the level of functional flexibility of lower extremity assessed using Chair Sit and Stand Test (CSST) at 6 weeks.(At the beginning and at the end of 6 weeks)
  • Change in the level of experienced pain assessed with using Short Form - McGill Pain Questionnaire (SF-McGill)(At the beginning and at the end of 6 weeks)
  • Change in the level of influence of patients' low back pain intensity on their daily life activities and functionality assessed using Oswestry Low Back Pain Disability Scale (ODI)(At the beginning and at the end of 6 weeks)
  • Change in the level of functional balance assessed using The Timed Up and Go Test (TUG).(At the beginning and at the end of 6 weeks)
  • Change in the level of functional flexibility of upper extremity assessed using Back Scratch Test (BST) at 6 weeks.(At the beginning and at the end of 6 weeks)
  • Change in the level of anxiety and depression assessed using Hospital Anxiety And Depression Scale (HADS) at 6 weeks(At the beginning and at the end of 6 weeks)
  • Change in the level of chronic functional impairment assessed using Health Assessment Questionnaire (HAQ) at 6 weeks(At the beginning and at the end of 6 weeks)

研究者

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

Sevim Öksüz

Senior Instructor

Eastern Mediterranean University

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