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Completed

NCT Number: NCT02457091

Project Get Fit With MS: Guidelines for Exercise Training and Fitness Outcomes in MS

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.

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Key information

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Illinois at Urbana-Champaign

Urbana-Champaign, Illinois, 61801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • currently pregnant

Treatment and study plan

Resistance exercise

Behavioral

strength training consists of 1-3 sets , 10-15 repetitions of 10 exercises targeting lower body, upper body and core muscle groups

Stretching exercise

Behavioral

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.

Primary outcomes

  1. Physical fitness (aerobic and muscular)

    Time frame: 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

  2. Walking and physical function

    Time frame: 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.

  3. Cognition

    Time frame: 0 and 6 months

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

  4. Physical activity

    Time frame: 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.

  5. Patient-rated outcomes

    Time frame: 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)

Secondary outcomes

  1. Body composition

    Time frame: 0 and 6 months

    DXA scan

  2. OCT Eye imaging

    Time frame: 0 and 6 months

  3. Cardiovascular function

    Time frame: 0 and 6 months

    ultrasonography techniques for arterial size, stiffness and blood pressure along with an ECG

  4. Blood biomarkers

    Time frame: 0 and 6 months

    Circulating inflammatory markers, cytokines and growth factors

Other outcomes

  1. Neurological examination

    Time frame: 0 and 6 months

  2. Exercise training parameters

    Time frame: 24 weeks

    strength-training program or a stretching and limbering program

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Acronym: GetFit

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 29, 2015
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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