Exercise in Multiple Sclerosis

NCT02716701 | Terminated

• 1 other identifier: 4607-B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise therapy in MS patients has proven benefits on mobility, mood, motor function and quality of life. While the beneficial effects of exercise on cardiovascular and musculoskeletal function are well known, there has recently been increased focus on the positive effects of exercise on brain structure and function. The goal of this study is to determine whether exercise can promote beneficial changes in brain function in MS patients.

Conditions

Multiple Sclerosis

Keywords

Exercise

Outcome Measures

Primary Outcomes (2)

• Change from baseline in brain structure as measured by magnetic resonance imaging scans at 7 months

  Magnetic resonance imaging (MRI) scans will be done at 1 month (baseline) and 7 months after subjects begin wearing a wristband activity tracker.

  7 months

• Change from baseline in brain structure as measured by magnetoencephalography (MEG) scans at 7 months

  MEG scans will be done at 1 month (baseline) and 7 months after subjects begin wearing a wristband activity tracker

  7 months

Study Arms (2)

Exercise Group

EXPERIMENTAL

Subjects will wear a wristband activity tracker to monitor their physical activity and will be asked to increase their activity level, with a goal of at least doubling their average daily activity (steps)

Behavioral: Exercise Group; Other: wristband activity tracker

Control Group

ACTIVE COMPARATOR

Subjects will wear a wristband activity tracker to monitor their physical activity and will not be encouraged to increase their activity level

Other: Control Group; Other: wristband activity tracker

Interventions

Exercise Group BEHAVIORAL

Exercise Group

Control Group OTHER

Control Group

wristband activity tracker OTHER

Control Group; Exercise Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with a confirmed diagnosis of MS by revised McDonald criteria
• Age ≥ 18 years
• Expanded Disability Status Scale (EDSS) 0-6.0, inclusive.
• Able to understand the consent process, and the use of the wristband activity tracker.
• Sedentary by self-report (answers no to the question: "Do you exercise regularly?"
• Willing to make sincere effort to comply with the study objective of increasing their physical activity as much as possible (with goal of at least 100% increase) and to maintain that increased activity level for six months (if randomized to the exercise group).

You may not qualify if:

• Current serious medical condition which would likely limit subject's ability to achieve sustained increase in physical activity, or put them at risk for doing so in the investigators' opinion (e.g. significant cardiovascular or respiratory disease, cancer, cancer, orthopedic disease, etc)
• Subjects that have a central nervous system disorder (in addition to MS) that is not considered secondary to MS
• Subjects that have implanted metal, pacemaker, etc. that may interfere with the MEG/MRI scan or who are otherwise unable to complete the MEG/MRI scan procedure without sedation (e.g. due to claustrophobia, obesity)
• weight \> 300 pounds

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Control Groups

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)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Adam F Carpenter, MD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 23, 2016
• Study Start: January 1, 2016
• Primary Completion: August 12, 2020
• Study Completion: August 13, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)