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临床试验/NCT03222596
NCT03222596已完成不适用

The Impact of 4-weeks Mild Exercise Training on Living Quality in Ambulatory and Non-ambulatory Multiple Sclerosis Individuals (EDSS From 0-8) in Motivational and Social Supporting Environment: a Randomized Controlled Trial

University of Rijeka2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change of pain intensity

研究概览

简要总结

The most common symptom displayed in patients with multiple sclerosis (MS) is a pronounced sense of fatigue that can have negative effect on functional ability and quality of life (QOL).

An important goal of researchers and clinicians involves improving the QOL of individuals with MS, and the exercise therapy represents potentially modifiable behavior that positively impacts on pathogenesis of MS and thus the QOL.

However, the main barrier for its application is low motivational level that MS patients experience due to fatigue with adjacent reduced exercise tolerability and mobility, and muscle weakness. Getting individuals with MS motivated to engage in continuous physical activity may be particularly difficult and challenging, especially those with severe disability or Expanded Disability Status Scale (EDSS 6-8).

Till now, researchers have focused their attention mainly on the moderate or vigorous intensity of exercise and on cardiorespiratory training in MS patients to achieve improvements in daily life quality, less indicating the exercise content, and most importantly, breathing exercises.

In addition, it is investigators intention to make exercise for MS patients more applicable and accessible, motivational and easier, but most important, productive.

Investigators think that MS patients experience more stress with aerobic exercise or moderate to high intensity programme exercise, and can hardly keep continuum including endurance exercise, or treadmill.

Hypothesis:

Investigators hypothesis is that 4-weeks of continuous low demanding or mild exercise programme with specific content and an accent on breathing exercise can attenuate primary fatigue in MS patients, especially in those with more severe disability or EDSS from 6-8, and provide maintenance of exercise motivation. Investigators also propose that important assistant factor for final goal achievement is social and mental support of the exercise group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise motivation and finally make better psychophysical functioning, and thus better QOL.

详细描述

This study will include individuals with multiple sclerosis including all MS types with EDSS from 0-8, who will be practicing at the Multiple Sclerosis Association in Rijeka for a period of 1 month, 2 times a week for 60 minutes per exercise (total 8h).

Participants will be randomly selected into 2 groups: ambulatory and non-ambulatory (wheelchair) MS individuals that will exercise - group (MSE), with related control group (ambulatory and non-ambulatory (wheelchair) individuals who will not exercise) (MSC). In addition, a group of healthy control subjects without MS (HC) will be evaluated.

Ambulatory and non-ambulatory group of individuals will exercise under the guidance of a physiotherapist. Exercise will be carried out sitting on the chairs for all participants, regardless of whether participants are able to walk or not. The practitioner of exercises will first demonstrate and explain each exercise. Participants will be emphasized during exercise to stop exercising if there is tiredness, weakness, pain or any other discomfort.

At the beginning of each exercise session, exercise will be initiated by warming muscles and breathing exercises. Therapeutic and abdominal breathing exercises with extended exhalation will be also conducted. Then follow the exercises of stretching and increasing the movement range of the upper limbs. Participants will work with dumbbells and elastic straps to strengthen the muscles of the upper extremities. In the end of training session, there will be devoted to stretching of the muscle groups involved during exercise.

Each participant involved in the study will undergo the examination through several functional tests at the beginning and up to 4-weeks of the study or exercise, including post-exercise questionnaire for motivation analysis:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with multiple sclerosis (EDSS 0-8)
  • Ambulatory and non-ambulatory (in wheelchairs)

排除标准

  • Individuals with contraindications for exercising
  • Individuals with multiple sclerosis with EDSS over 8

研究组 & 干预措施

Multiple Sclerosis Exercise

Experimental

Ambulatory and non-ambulatory MS individuals that will exercise-group (MSE). Intervention is exercise training.

干预措施: Exercise training (Behavioral)

Multiple Sclerosis Control (no-Exercise)

No Intervention

Ambulatory and non-ambulatory MS individuals that will not exercise-group (MSC).

结局指标

主要结局

Change of pain intensity

时间窗: baseline, after 4 weeks

Assessment of pain level using a "Visual Analogue Scale" (VAS) for pain

Change of grip strength.

时间窗: baseline, after 4 weeks

Grip strength testing using hand hydraulic dynamometer.

Change of fatigue intensity

时间窗: baseline, after 4 weeks

Fatigue estimation using the "Modified Fatigue Impact Scale" (MFIS)

Motivation.

时间窗: baseline, after 4 weeks

Survey made from questions for subjective self-evaluation of motivation efficiency.

Change of mental abilities and limitations.

时间窗: baseline

Assessment of cognitive ability using the "Standardized Mini-Mental State Examination" test (SMMSE).

Change of physical abilities and limitations.

时间窗: baseline, after 4 weeks

Assessment of the functional independence of daily activities and severity of individuals disability using the "Barthell Index".

Change of quality of life.

时间窗: baseline, after 4 weeks.

Evaluation of Quality of Life using the abbreviated version of the "36-Item Short Form Survey" (36-SF) including physical function, role of constraints due to physical problems, physical pain, general health perception, energy level, social function, the role of limitations due to psychological problems and general mental health.

次要结局

未报告次要终点

研究者

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

Tanja Grubic Kezele

PhD, MD

University of Rijeka

研究点 (2)

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