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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02457091
Acronym
GetFit
Enrollment
32
Registered
2015-05-29
Start date
2013-10-31
Completion date
2014-12-31
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, exercise, home-based, training, fitness

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.

Interventions

BEHAVIORALResistance exercise

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

BEHAVIORALStretching 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.

Sponsors

University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physical activity0 and 6 monthsan accelerometer along with the Godin Leisure Time Physical Activity Questionnaire and 7-day Physical Activity Recall Questionnaire will be used to measure physical activity.
Physical fitness (aerobic and muscular)0 and 6 monthsPhysical 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 function0 and 6 monthsA 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.
Cognition0 and 6 monthsThe Brief International Cognitive Assessment for MS battery will be used.
Patient-rated outcomes0 and 6 monthsSelf 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

MeasureTime frameDescription
Blood biomarkers0 and 6 monthsCirculating inflammatory markers, cytokines and growth factors
Body composition0 and 6 monthsDXA scan
OCT Eye imaging0 and 6 months
Cardiovascular function0 and 6 monthsultrasonography techniques for arterial size, stiffness and blood pressure along with an ECG

Other

MeasureTime frameDescription
Neurological examination0 and 6 months
Exercise training parameters24 weeksstrength-training program or a stretching and limbering program

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026