NCT01518660

Brief Summary

The purpose of this study is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

April 1, 2013

Enrollment Period

1.9 years

First QC Date

January 6, 2012

Last Update Submit

December 1, 2014

Conditions

Multiple Sclerosis (Relapsing Remitting)

Keywords

Resistance TrainingStrength Training

Outcome Measures

Primary Outcomes (1)

  • Blood-borne biomarkers

    Resting levels of bloodbourne biomarkers; * Cytokines * Neurotrophins

    Change from baseline to 24 weeks

Secondary Outcomes (6)

  • Neuro-muscular function of knee extensors

    Change from baseline to 24 weeks

  • Walking performance

    Change from baseline to 24 weeks

  • Self-reported measures

    Change from baseline to 24 weeks

  • Brain volume

    Change from baseline to 24 weeks

  • Body Composition

    Change from baseline to 24 weeks

  • +1 more secondary outcomes

Study Arms (2)

Training

EXPERIMENTAL
Behavioral: Training

Control

NO INTERVENTION

Interventions

TrainingBEHAVIORAL

Bi-weekly progressive resistance training

Training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed relapsing-remitting MS according to the McDonald criteria
  • Expanded Disability Status Scale (EDSS) between 2.0 and 5.5
  • Be able to train twice a week at the University
  • Use interferon based medication

You may not qualify if:

  • Alcohol abuse, Alzheimer's and pacemaker (or other metallic implant)
  • Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
  • Having had an attack in a period of 8 weeks prior to the start of the intervention period
  • Having an attack during the intervention period
  • Pregnancy
  • Systematic resistance training in a period of 3 months prior to the start of the intervention period.
  • Training adherence of less than 85%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MS Clinic, Department of Neurology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Sport Science, Aarhus University

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Tue Kjølhede, M.Sc.

    Sport Science, Department of Public Health, Aarhus University

    PRINCIPAL INVESTIGATOR

  • Ulrik Dalgas, Ph.D.

    Sport Science, Department of Public Health, Aarhus University

    STUDY CHAIR

  • Kristian Vissing, Ph.D.

    Sport Science, Department of Public Health, Aarhus University

    STUDY CHAIR

  • Thor Petersen, Dr.med

    MS Clinic, Department of Neurology, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 26, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 2, 2014

Record last verified: 2013-04

Locations

DK(2)