Exercise and Brain Health in MS

NCT03638739 | Completed

• 1 other identifier: RG-1707-28348
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity is now recognized as a therapy for Multiple Sclerosis (MS) that not only improves physical fitness and functional mobility, but there is some evidence that it may also positively influence the more invisible symptoms of the disease that represent "brain health" - fatigue, depression and cognitive impairment. One important feature of physical activity is that it reduces inflammation throughout the body and the brain. The goal of this research is to determine whether people with MS feel less fatigue, depression and cognitive impairment after a program of exercise because there is a decrease in the state of inflammation in the brain.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• Change in Perceived Fatigue

  Changes in perceived fatigue as a result of the intervention will be assessed through changes in scores on the Modified Fatigue Impact Scale (MFIS-21).

  Outcome will be measured at Baseline, 12 weeks and 24 weeks.

• Change in Inflammatory Markers

  Inflammatory markers will be measured from the blood. Participants will have 15ml of blood drawn by a trained phlebotomist. Levels of serum cytokines (TNF, IL6, IL10, IL1RA) will be measured in using the custom created Milliplex MAP Human Magnetic Bead Panel (Millipore, ON, CA). Cellular immunophenotyping will be performed to test whether there are changes in cellular inflammation.

  Outcome will be measured at Baseline, 12 weeks and 24 weeks.

• Change in Depression

  Change in depression will be measured with the Hospital Anxiety and Depression Scale (HADS).

  Outcome will be measured at Baseline, 12 weeks and 24 weeks.

• Change in Cognition

  Changes in cognitive ability will be assessed by using the Brief International Cognitive Assessment for MS (BICAMS) test battery.

  Outcome will be measured at Baseline, 12 weeks and 24 weeks.

Secondary Outcomes (3)

• Change in Aerobic Capacity

  Outcomes will be measured at Baseline, 12 weeks and 24 weeks.

• Change in Muscle Strength

  Outcomes will be measured at Baseline, 12 weeks and 24 weeks.

• Change in Perceived Quality of Life (QOL)

  Outcomes will be measured at Baseline, 12 weeks and 24 weeks.

Study Arms (2)

Exercise

EXPERIMENTAL

Participants will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS for 12 weeks at McMaster University. Following this, they will return to their normal daily activities for a further 12 weeks.

Other: Twice-weekly exercise

Wait-list Control

EXPERIMENTAL

Participants will engage in their usual daily activities for the first 12 weeks of the study, then will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS at McMaster University for the 2nd 12 weeks.

Other: Twice-weekly exercise

Interventions

Twice-weekly exercise OTHER

An individualized exercise plan, incorporating aerobic and resistance exercises, following the Physical Activity Guideline recommendations will be provided for each participant.

Exercise; Wait-list Control

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Relapsing-Remitting MS (RRMS) with mild-moderate disability (EDSS 2-5)
• Aged 18-60
• Score of ≥ 10 on MFIS-5\*
• Medical clearance to participate in physical activity \* The MFIS-5 is an abbreviated version of the 21-item MFIS, consisting of 5 of the 21 items of the MFIS that most strongly correlate with the total MFIS score. A score ≥ 10 on the MFIS-5 is considered to indicate "high-level" of fatigue

You may not qualify if:

• Current participation in regular physical activity (at least twice-weekly)
• Other serious medical condition that might impair ability to participate in strength or aerobic exercise

Sponsors & Collaborators

• McMaster University: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Physical Activity Centre for Excellence

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 20, 2018
• Study Start: August 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: September 1, 2019
• Last Updated: March 5, 2021

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)