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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Stretching exercise; Behavioral: Resistance exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana-Champaign, Illinois, United States, 61801
      • University of Illinois at Urbana-Champaign

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stretching exercise; 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.	Behavioral: Stretching exercise; 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.
Experimental: Resistance exercise; 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.	Behavioral: Resistance exercise; strength training consists of 1-3 sets , 10-15 repetitions of 10 exercises targeting lower body, upper body and core muscle groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0 and 6 months
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.	0 and 6 months
Cognition	The Brief International Cognitive Assessment for MS battery will be used.	0 and 6 months
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.	0 and 6 months
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)	0 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	DXA scan	0 and 6 months
OCT Eye imaging		0 and 6 months
Cardiovascular function	ultrasonography techniques for arterial size, stiffness and blood pressure along with an ECG	0 and 6 months
Blood biomarkers	Circulating inflammatory markers, cytokines and growth factors	0 and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological examination		0 and 6 months
Exercise training parameters	strength-training program or a stretching and limbering program	24 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Lara Pilutti, PhD, University of Illinois at Urbana-Champaign

Publications and helpful links

Helpful Links

• Exercise Neuroscience Research Laboratory

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: exercise; multiple sclerosis; training; fitness; home-based
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: NMSS IL-0010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No