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

Multiple Sclerosis Clinical Trial

— GetFit  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457091
• Other study ID #: NMSS IL-0010
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2014
• Last updated: December 1, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 54 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana-Champaign	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurological examination		0 and 6 months	No
Other	Exercise training parameters	strength-training program or a stretching and limbering program	24 weeks	Yes
Primary	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	No
Primary	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	No
Primary	Cognition	The Brief International Cognitive Assessment for MS battery will be used.	0 and 6 months	No
Primary	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	No
Primary	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	No
Secondary	Body composition	DXA scan	0 and 6 months	No
Secondary	OCT Eye imaging		0 and 6 months	No
Secondary	Cardiovascular function	ultrasonography techniques for arterial size, stiffness and blood pressure along with an ECG	0 and 6 months	No
Secondary	Blood biomarkers	Circulating inflammatory markers, cytokines and growth factors	0 and 6 months	No

External Links

•   Exercise Neuroscience Research Laboratory