Clinical trial NCT02457091: Project Get Fit With MS: Guidelines for Exercise Training and Fitness Outcomes in MS
Official title: Project GET FIT With MS: Guidelines for Exercise Training and Fitness Outcomes in MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
exercise
home-based
training
fitness
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Physical fitness (aerobic and muscular)
timeFrame: 0 and 6 months
measure: Walking and physical function
timeFrame: 0 and 6 months
measure: Cognition
timeFrame: 0 and 6 months
measure: Physical activity
timeFrame: 0 and 6 months
measure: Patient-rated outcomes
timeFrame: 0 and 6 months
Secondary outcomes:
measure: Body composition
timeFrame: 0 and 6 months
measure: OCT Eye imaging
timeFrame: 0 and 6 months
measure: Cardiovascular function
timeFrame: 0 and 6 months
measure: Blood biomarkers
timeFrame: 0 and 6 months
Other outcomes:
measure: Neurological examination
timeFrame: 0 and 6 months
measure: Exercise training parameters
timeFrame: 24 weeks
Locations:
city: Urbana-Champaign
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Lara Pilutti, PhD
role: PRINCIPAL_INVESTIGATOR
References: