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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Resistance exercise
Stretching exercise
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, exercise, home-based, training, fitness

Eligibility Criteria

18 Years - 54 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stretching exercise

Resistance exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Physical fitness (aerobic and muscular)
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
Walking and physical function
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
The Brief International Cognitive Assessment for MS battery will be used.
Physical activity
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
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 Outcome Measures

Body composition
DXA scan
OCT Eye imaging
Cardiovascular function
ultrasonography techniques for arterial size, stiffness and blood pressure along with an ECG
Blood biomarkers
Circulating inflammatory markers, cytokines and growth factors

Full Information

First Posted
March 17, 2014
Last Updated
December 1, 2015
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT02457091
Brief Title
Project Get Fit With MS: Guidelines for Exercise Training and Fitness Outcomes in MS
Acronym
GetFit
Official Title
Project GET FIT With MS: Guidelines for Exercise Training and Fitness Outcomes in MS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, exercise, home-based, training, fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stretching exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Resistance exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise
Intervention Description
strength training consists of 1-3 sets , 10-15 repetitions of 10 exercises targeting lower body, upper body and core muscle groups
Intervention Type
Behavioral
Intervention Name(s)
Stretching exercise
Intervention Description
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 Outcome Measure Information:
Title
Physical fitness (aerobic and muscular)
Description
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
Time Frame
0 and 6 months
Title
Walking and physical function
Description
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.
Time Frame
0 and 6 months
Title
Cognition
Description
The Brief International Cognitive Assessment for MS battery will be used.
Time Frame
0 and 6 months
Title
Physical activity
Description
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.
Time Frame
0 and 6 months
Title
Patient-rated outcomes
Description
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)
Time Frame
0 and 6 months
Secondary Outcome Measure Information:
Title
Body composition
Description
DXA scan
Time Frame
0 and 6 months
Title
OCT Eye imaging
Time Frame
0 and 6 months
Title
Cardiovascular function
Description
ultrasonography techniques for arterial size, stiffness and blood pressure along with an ECG
Time Frame
0 and 6 months
Title
Blood biomarkers
Description
Circulating inflammatory markers, cytokines and growth factors
Time Frame
0 and 6 months
Other Pre-specified Outcome Measures:
Title
Neurological examination
Time Frame
0 and 6 months
Title
Exercise training parameters
Description
strength-training program or a stretching and limbering program
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Pilutti, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana-Champaign
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.enrl.net
Description
Exercise Neuroscience Research Laboratory

Learn more about this trial

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

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