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

NCT02457091 | Completed Phase 2 DMC

• 1 other identifier: NMSS IL-0010
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Body composition

  0 and 6 months

• OCT Eye imaging

  0 and 6 months

• Cardiovascular function

  0 and 6 months

• Blood biomarkers

  0 and 6 months

Other Outcomes (2)

• Neurological examination

  0 and 6 months

• Exercise training parameters

  24 weeks

Study Arms (2)

Stretching exercise

ACTIVE COMPARATOR

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

Resistance exercise

EXPERIMENTAL

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

Interventions

Resistance exercise BEHAVIORAL

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

Resistance exercise

Stretching exercise BEHAVIORAL

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.

Stretching exercise

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• currently pregnant

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana-Champaign, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Resistance Training; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lara Pilutti, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: May 29, 2015
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)