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临床试验/NCT02457091
NCT02457091已完成2 期

Project GET FIT With MS: Guidelines for Exercise Training and Fitness Outcomes in MS

University of Illinois at Urbana-Champaign1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1
主要终点
Walking and physical function

研究概览

简要总结

The purpose of this study is to test different types of exercise training for people with multiple sclerosis (MS). The exercise program is based on physical activity guidelines that have been developed specifically for people with MS. The investigators believe these guidelines will be effective for improving physical fitness and function in persons with mild-to-moderate MS.

详细描述

Most adults with multiple sclerosis (MS) are physically inactive. One approach to address physical inactivity in this population has involved the provision of physical activity guidelines. Such physical activity guidelines are an important tool for exercise prescription, promotion, and monitoring, and recommend that people with MS "participate in at least 30 minutes of moderate intensity aerobic activity 2 times per week and strength training exercises for major muscle groups 2 times per week." The guidelines were developed from a systematic literature review and have yet to be tested for efficacy in improving fitness or other outcomes. This study will test that efficacy of aerobic and resistance training alone and in combination (based on the MS physical activity guidelines) for improving physical fitness and other outcomes (e.g., walking, thinking, MS symptoms) in persons with MS who have mild-to-moderate disability. Such an examination will be important to confirm the efficacy of the exercise prescription for people with MS and health-care providers. The investigators will further perform an exploratory analysis of blood biomarkers and eye imaging parameters to examine some of the mechanisms of exercise training effects in persons with MS.

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 (Investigator)

入排标准

年龄范围
18 Years 至 54 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •a definite diagnosis of MS
  • •self-reported Expanded Disability Status Scale (EDSS) score < 6.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 3.0
  • •relapse free in past 30 days
  • •willing and able to visit the University of Illinois at Urbana-Champaign for on seven occasions (two testing visits; five training visits) and participate in a 6-month home-based exercise program
  • •non-exerciser
  • •asymptomatic and physician approval for undertaking exercise testing and training

排除标准

  • •currently pregnant

研究组 & 干预措施

Stretching exercise

Active Comparator

The stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week.

干预措施: Stretching exercise (Behavioral)

Resistance exercise

Experimental

The resistance condition will consist of 1-3 sets, 10-15 repetitions of 12 exercises targeting lower body, upper body, and core muscle groups performed 2 days per week.

干预措施: Resistance exercise (Behavioral)

结局指标

主要结局

Walking and physical function

时间窗: 0 and 6 months

A timed 25-Foot walk, a 6 -minute walk, walking on a GaitRite electronic walkway, 9-hole peg test and the use of a force platform will measure walking and physical function.

Cognition

时间窗: 0 and 6 months

The Brief International Cognitive Assessment for MS battery will be used.

Physical activity

时间窗: 0 and 6 months

an accelerometer along with the Godin Leisure Time Physical Activity Questionnaire and 7-day Physical Activity Recall Questionnaire will be used to measure physical activity.

Patient-rated outcomes

时间窗: 0 and 6 months

Self reporting questionnaires on fatigue, mobility, anxiety, depression, QoL, and social cognitive theory variable (e.g. Exercise Self-Efficacy Scale, Late-life function and disability scale)

Physical fitness (aerobic and muscular)

时间窗: 0 and 6 months

Physical fitness determined by VO2 peak using a computer-driven cycle ergometer Muscular fitness determined by a seated dynamometer machine for leg strength and a hand dynamometer for upper body strength

次要结局

  • Body composition(0 and 6 months)
  • OCT Eye imaging(0 and 6 months)
  • Cardiovascular function(0 and 6 months)
  • Blood biomarkers(0 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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