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临床试验/NCT03779724
NCT03779724已完成不适用

The Effects of Isokinetic Exercises on Muscle Strength, Joint Position Sense, and Kinesiophobia in Patients With Multiple Sclerosis: a Randomized Controlled Trial

Aksaray University Training and Research Hospital4 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2015年7月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
4
主要终点
Visual Analog Scale

研究概览

简要总结

The investigators evaluated the effects of isokinetic muscle strengthening exercises of the quadriceps and hamstring on muscle strength, joint position sense, pain, kinesiophobia and quality of life in patients with multiple sclerosis.

详细描述

Objective

To evaluate the effects of isokinetic exercises on muscle strength, knee joint position sense, pain, kinesiophobia, and quality of life in patients with multiple sclerosis.

Design: Randomized controlled trial. Setting: Outpatient clinic. Participants: Fifty patients with multiple sclerosis. Interventions: Fifty patients who met the inclusion criteria were randomized to an isokinetic exercise (n:25) or home exercise programme (n:25). Sequentially numbered opaque envelopes were used for randomization.

Outcome measures: The outcome measures were the peak torque/body mass index of quadriceps and hamstring muscles at 60°/s and 180°/s velocities, the hamstring/quadriceps ratios at the same velocities, absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of joint position sense of the less and more affected knees, and the scores of Multiple Sclerosis Quality of Life-54, Visual Analogue Scale, and Tampa Scale of Kinesiophobia.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • definite relapsing remitting MS and secondary progressive MS diagnosis
  • mild and moderate MS determined by Kurtzke Expanded Disability Status Scale (EDSS) scores below 6.5
  • a disease duration of more than one year.

排除标准

  • having an acute exacerbation within the last three months
  • intravenous pulse steroid therapy in the last four weeks
  • grade 3-4 spasticity according to the Modified Ashworth Scale
  • severe vision impairment
  • severe fatigue and depression
  • past knee surgery
  • other neurologic diseases
  • systemic diseases
  • pregnancy
  • having received an exercise program within the last four weeks.

结局指标

主要结局

Visual Analog Scale

时间窗: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

Pain intensity was evaluated with the Visual Analog Scale. Using a ruler, a 10 cm line was drawn which provided a range of scores from 0-100. Than the patients marked the point that showed their pain intensity on this line. A higher score in Visual Analog Scale indicates greater pain intensity.

Tampa Scale of Kinesiophobia

时间窗: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

Kinesiophobia which is described as fear of movement and physical activity was evaluated using the Tampa Scale of Kinesiophobia, which is a 17-item self-report survey. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia. If the total score was above 37 points, the patient was considered to have a high level of kinesiophobia.

Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score

时间窗: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

This is a multidimensional health-related quality of life measure that combines both generic and multiple sclerosis-specific symptoms in a single instrument. The 54 items are divided into 12 multi-item and 2 single-item scales.Health distress, overall quality of life, emotional well-being, role limitations-emotional and cognitive funtion items' final scores averaged and mental composite score was calculated. Physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress items' final scores were averaged and physical composite score was obtained.Total score was obtained by averaging the mental and physical composite scores.Final scores can be between 0-100 points for total, mental, physical and pain scores. Higher values indicate better quality of life for total, physical and mental scores and worser pain levels for pain score.

Isokinetic Muscle Strength Test of the More and Less Affected Knees

时间窗: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

The peak torque/body mass index of the quadriceps and hamstring muscles at 60°/s and 180°/s velocities were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) in Newton/meter. A definite muscle strength value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate better muscle strength.

Joint Position Sense of the More and Less Affected Knees

时间窗: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

Absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of the more and less affected knees were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) with active-active angular reproduction method. Estimating the target angel procedure was repeated at 45°, 15°, and 60° and for both the more and less affected legs. After the joint position sense testing, three angles estimated by the patients were averaged, and the angular error was calculated for each target angle. Absolute angular error was calculated by averaging the angular errors, regardless of the numbers being negative or positive. The absolute angular error values of the three target angles were averaged to obtain the mean absolute angular errors. A definite angular error value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate worser joint position sense.

次要结局

未报告次要终点

研究者

发起方
Aksaray University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Melek Aykut Selçuk

Principal Investigator

Aksaray University Training and Research Hospital

研究点 (4)

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