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临床试验/NCT04357145
NCT04357145Unknown不适用

The Effect of Different Exercise Dosages on Exercise Adherence, Pain and Functionality in Patients With Knee Osteoarthritis

Marmara University0 个研究点目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Change from Knee Osteoarthritis Exercise Adherence Scale Points at 12 Weeks

研究概览

简要总结

Although the effects of different exercise dosages for patients with osteoarthritis are compared in the literature, it is seen that studies on which exercise dosage is better are insufficient.The planned study has 2 main objectives:

  • To examine the effects of different exercise dosages on exercise dependence
  • To investigate the effect of different exercise dosages on pain and functional results

详细描述

Knee osteoarthritis (KO) is the most common musculoskeletal problem worldwide, leading to pain and loss of locomotor function. The Framingham Osteoarthritis Study shows that 19% of adults have radiographic effects on the knee joint. Individuals with advanced symptomatic KO have difficulties in their daily life activities. Among all diseases, KO most affects activities such as walking, climbing stairs and housework. A wide range of physiotherapy treatment methods are available in KO treatment such as strengthening exercises, aquatic exercises, aerobic exercises, proprioception exercise, orthotics, taping methods and the use of electrophysiological agents. High-quality evidences suggests that land-based exercise therapy maintains its positive effect on pain, quality of life and functionality for 2-6 months after the treatment. The dosage of exercise therapy can be adjusted by the duration, frequency, or resistance of the exercise. However, evidence-based information on exercise dosage is limited in KO treatment. While KO is treated in physiotherapy clinics, it is also supported by home exercises during and after treatment. However, it is a clinical problem that patients show low adherence to home exercise. With this study, it is aimed to compare the exercise adherence of patients who are given home exercise with different exercise dosages and to show their functional results. Participants with KO aged between 40-85 years will be included in the study and randomly divided into two groups. The number of repetitions of the high dosage exercise group will be 2 times more than standard exercise group. Participants will be asked to apply home exercise programs 4 times a week. Exercise adherence, pain, kinesiophobia and functionality will be evaluated. Our study will be the first to demonstrate the effect of different home exercise dosages on exercise adherence. The information to be obtained with this study is thought to contribute to the preparation of a better home exercise program. With the information to be obtained through this study, it can contribute to the preparation of a better home exercise program.The planned study has 2 main objectives:

  • To examine the effects of different exercise dosages on exercise dependence
  • To investigate the effect of different exercise dosages on pain and functional results

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
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a diagnosis of unilateral or bilateral knee osteoarthritis.
  • Being between stage 1-3 according to Kellgren-Lawrence criteria.
  • Having at least 3 months of pain duration and decreased functioning.
  • Being a volunteer who can read and write

排除标准

  • Physiotherapy or other conservative therapy during the previous 3 months or a history of major knee trauma.
  • Having Inflammatory joint disease, hip symptoms more aggravating than the knee symptoms,
  • Having comorbidities not allowing exercise such as cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance.
  • Participants with previously performed knee replacement surgery

结局指标

主要结局

Change from Knee Osteoarthritis Exercise Adherence Scale Points at 12 Weeks

时间窗: Week 3, Week 6, Week 9, Week 12

It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.

Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Points at 12 weeks

时间窗: Baseline, Week 3, Week 6 and Week 12

(WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Change from Exercise Adherence (with Self Reported Exercise Diary) at 12 Weeks Percentages at 12 Weeks

时间窗: Week 3, Week 6, Week 9, Week 12

In the exercise diary, the participant will note the number of exercises done at home next to the image showing the exercise example day by day.The percentage adherence to the prescribed exercise regimen was calculated by dividing the number of exercises performed by the number of exercises prescribed and multiplying by 100.

次要结局

  • Change from Timed 10 Meter Walk Test Score at 12 Weeks(Baseline, Week 3, Week 6 and Week 12)
  • Change from Visual Analogue Scale(for Pain) Points at 12 Weeks(Baseline, Week 3, Week 6 and Week 12)
  • Change from Tampa Scale for Kinesiophobia Points at 12 Weeks(Baseline, Week 3, Week 6 and Week 12)
  • Change from Timed Up&Go Test Score at 12 Weeks(Baseline, Week 3, Week 6 and Week 12)

研究者

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

Eda Tonga

Doctor of Philosophy

Marmara University

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