Physical Activity in Multiple Sclerosis (MS): A Novel Approach to Study Outcomes

NCT02297932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-08-18

No results posted yet for this study

Summary

Physical activity and exercise interventions in multiple sclerosis (MS) have received great attention most recently and there exists several randomized clinical trials (RCTs) addressing the outcomes associated with such intervention. The majority of such interventions have primarily focused on directly influencing disease processes (e.g., inflammation, neurotrophic factors), the reduction of symptoms (e.g., fatigue, depression), improvement in physical functioning (e.g., gait, strength) or enhancing one's quality of life. To date, the evidence suggests that exercise intervention in MS holds anywhere from minimal to great promise depending on the outcome of interest. For some outcomes such as depression or cognition, findings are even less optimistic, being null, or inconsistent, at best. These inconsistent findings may be attributed to methodological issues such as use of subjective reports, lack of appropriate control group, poor compliance, and sample selection. The proposed investigation aims to address some of these issues by: (1) Obtaining objective measures of outcomes of interest (i.e., fatigue, cognition, and participation/activities of daily living \[ADLs\]) and; (2) assessing certain person-specific factors (e.g., personality) and intermediary factors that may be influenced by physical activity and indirectly result in improved outcomes (e.g., improvement in sleep and subsequent improvement in fatigue and/or cognition). Thus, the primary objective of the proposed investigation is to: (1) utilize innovative and objective measures of outcomes and; (2) obtain comprehensive assessment of intermediary variables (e.g., sleep) or person-specific characteristics (e.g., personality), which together may explain the inconsistent findings in the literature and has the following specific aims:

To achieve these goals, individuals will complete a comprehensive assessment of cognition, person-specific factors, intermediary factors, physical fitness, and functional magnetic resonance imaging (fMRI) prior to and following a home based exercise intervention.

Conditions

Interventions

BEHAVIORAL

Strength training

Participants will engage in a home-based strength training program.

BEHAVIORAL

Stretching

Participants will engage in a home-based stretching training program

Sponsors & Collaborators

  • University of Illinois at Urbana-Champaign

    collaborator OTHER
  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Matthew Weiner · Kessler Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

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 NCT02297932 on ClinicalTrials.gov