Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment aerobic exercise
Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborator German Federal Ministry of Education and Research
Start date December 2013
End date April 2016
Trial size 68 participants
Trial identifier NCT02005237, 031A130, AERCONN

Summary

Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date, there are no available treatments to improve cognition in this patient population. Some evidence from animal studies and small clinical trials suggest that aerobic exercise might beneficially affect cognitive function in MS. The aim of this randomized-controlled trial is to explore if an aerobic exercise training program can enhance cognition in MS. In addition, we will employ neuroimaging markers to determine if exercise alters measures of brain structure and function.

Patients will be randomly assigned to either a 3-months exercise program (bicycle ergometry, 2-3 session per week) or a waitlist control group. The primary endpoint of the study is a test of verbal learning and memory. Secondary endpoints include neuroimaging markers of functional and structural connectivity in the brain. We hypothesize that exercise will improve verbal learning and memory and beneficially affect measures of brain connectivity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Aerobic exercise on a bicycle ergometer, tailored to the individual's level of fitness. Duration: 12 weeks with 2-3 sessions per week.
aerobic exercise
3-months exercise program tailored to the individual level of aerobic fitness. Patients will exercise on a bicycle ergometer (2-3 session per week) according to a predefined training plan with increasing duration and intensity
(No Intervention)
No intervention (patients randomized to this group will be offered access to the training program after completion of the trial)

Primary Outcomes

Measure
Change in Verbal Learning and Memory
time frame: Baseline and at Month 3 (end of intervention)

Secondary Outcomes

Measure
Change in Functional Connectivity
time frame: Baseline and at Month 3 (end of intervention)
Change in Structural Connectivity
time frame: Baseline and at Month 3 (end of intervention)
Change in Neuropsychological Function
time frame: Baseline and at Month 3 (end of intervention)

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Relapsing-remitting multiple sclerosis according to McDonald criteria - Currently in remission - Disease duration < 10 years - Low to moderate physical disability (EDSS 0-3.5) - On stable immunotherapy (>3 months) or without any planned treatment for the next year Exclusion Criteria: - Patients who are not able to understand the study concept due to severe cognitive deficits or psychiatric comorbidity - Patients currently taking psychoactive drugs - Patients unable to undergo aerobic exercise training for medical reasons - Patients with active disease or uncertain stability under current immunomodulatory therapy (as judged by the treating neurologist) - Patients with implants or body modifications (e.g. dental implants, piercings, tattoos, pacemakers etc.) which might interfere with MEG and MRI assessments - Patients unable to travel to the study center 2-3 times a week for the duration of the study

Additional Information

Official title Randomized Controlled Trial Investigating the Effects of a Standardized Aerobic Exercise Intervention on Cognitive Function and Brain Connectivity in Relapsing-remitting Multiple Sclerosis
Principal investigator Stefan M Gold, PhD
Description Background: Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date, there are no available treatments to improve cognition in this patient population. Some evidence from animal studies and small clinical trials suggest that aerobic exercise might beneficially affect cognitive function in MS. Aims: This study aims to explore the potential of an aerobic exercise program on brain structure and function in MS in a single-blind, randomized controlled phase IIa trial. We hypothesize that exercise will improve verbal learning and memory (primary endpoint) as well as induce changes in neuroimaging markers of structural and functional central nervous system (CNS) connectivity (secondary endpoints). Tertiary outcomes will include walking ability, motor function and coordination, as well as patient-based outcomes (depression, fatigue, and health-related quality of life). Design: This is a single-blind, randomized, controlled phase IIa trial with a parallel group design comparing 3 months of standardized aerobic exercise training (bicycle ergometry) to a waitlist control group (superiority framework). The allocation ratio of exercise to waitlist control is 1:1 with a sample size of n=60.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.