Exercise & Brain Health in MS

NCT02263339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-06-19

No results posted yet for this study

Summary

The purpose of this study is to learn more about multiple sclerosis (MS). The investigators are studying whether aerobic exercise is better than a stretching program at improving brain health in people with MS. We want to learn:

1. If it is safe and practical for people with MS to participate in an aerobic exercise program with the goal of increasing cardiac fitness. Cardiac fitness is measured with exercise stress tests at the beginning and end of the study.
2. If aerobic exercise improves brain metabolism, a reflection of brain health, more than stretching. Brain metabolism is measured by MRIs at the beginning and end of the study.

There is a 50% chance of being in the aerobic exercise or the stretching program.

There are between 8 and 36 visits to OHSU, depending on the intervention group. The total duration of the study is at most 21 weeks.

Conditions

Interventions

BEHAVIORAL

Aerobic Exercise

Each subject will exercise 30 minutes per session, four times per week for 8 weeks at the OHSU Human Performance Laboratory (HPL). Choice of treadmill or cycle ergometer for each subject will be made based on subject ability by the HPL staff and maintained for the duration of the study. Exercise intensity will be determined by training heart rate to be provided to the subject based on the anaerobic threshold during initial stress test. Throughout the study, patients will be instructed not to alter their diet or baseline level of activity.

BEHAVIORAL

Stretching

Each subject will follow a self-guided stretching program 30 minutes per session, four times per week for 8 weeks. The initial session will be supervised at the OHSU Human Performance Laboratory (HPL) and additional supervised sessions will occur every 2 weeks to support compliance with the program. Throughout the study patients will be instructed not to alter their diet or baseline level of activity.

BEHAVIORAL

Aerobic Exercise- Healthy Subjects

Each subject will follow a self-guided aerobic exercise program 30 minutes per session, four times per week for 8 weeks. The initial session will be supervised at the OHSU Human Performance Laboratory (HPL) and additional supervised sessions will occur every 2 weeks to support compliance with the program. Throughout the study patients will be instructed not to alter their diet or baseline level of activity.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Rebecca Spain, MD, MSPH · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-04-30
Completion
2016-05-25

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263339 on ClinicalTrials.gov