NCT00381576

Brief Summary

The purpose of the present investigation is to determine whether MS patients can tolerate and benefit from heavy progressive resistance training. A second purpose is to determine both neural and muscle morphological adaptations to heavy progressive resistance training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2006

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

September 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 12, 2008

Status Verified

August 1, 2008

Enrollment Period

1.3 years

First QC Date

September 27, 2006

Last Update Submit

August 11, 2008

Conditions

Multiple Sclerosis

Keywords

Resistance trainingStrength trainingTraining adaptationsCNS

Outcome Measures

Primary Outcomes (1)

  • Muscle strength (isokinetic testing)

    Before and after the intervention

Secondary Outcomes (8)

  • Functional capacity (Six minute walk test, 10m walk test, chair rise, stair climbing)

    Before and after the intervention

  • Muscle biopsies from m. vastus lateralis

    Before and after the intervention

  • % Fat (skinfold)

    Before and after the intervention

  • Blood samples (immunologic parameters)

    Before and after the intervention

  • Fatigue (Fatigue Severity Scale - FSS, Modified Fatigue Inventory - MFI-20)

    Before and after the intervention

  • +3 more secondary outcomes

Study Arms (1)

A

EXPERIMENTAL

12 weeks of resistance training

Behavioral: Resistance training

Interventions

Resistance trainingBEHAVIORAL

Intervention group: 12 weeks of resistance training for the lower extremity. Control group: No intervention - 12 weeks of normal daily living

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Relapsing Remitting Multiple Sclerosis according to the McDonald criteria
  • Expanded Disability Status Scale Score between 3,0-5,5
  • Be able to walk at least 100m
  • Be able to train twice a week at the University

You may not qualify if:

  • Alcohol abuse, Alzheimer's and pacemaker
  • 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, 8000, Denmark

Location

Department of Sports Science, University of Aarhus

Aarhus, 8200, Denmark

Location

Related Publications (2)

  • Dalgas U, Stenager E, Lund C, Rasmussen C, Petersen T, Sorensen H, Ingemann-Hansen T, Overgaard K. Neural drive increases following resistance training in patients with multiple sclerosis. J Neurol. 2013 Jul;260(7):1822-32. doi: 10.1007/s00415-013-6884-4. Epub 2013 Mar 13.

    PMID: 23483214DERIVED

  • Dalgas U, Severinsen K, Overgaard K. Relations between 6 minute walking distance and 10 meter walking speed in patients with multiple sclerosis and stroke. Arch Phys Med Rehabil. 2012 Jul;93(7):1167-72. doi: 10.1016/j.apmr.2012.02.026. Epub 2012 Mar 12.

    PMID: 22421626DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ulrik Dalgas, Ph.d. Stud.

    Department of Sports Science, University of Aarhus

    PRINCIPAL INVESTIGATOR

  • Thorsten Ingemann-Hansen, Professor

    Department of Sports Science, University of Aarhus

    STUDY CHAIR

  • Egon Stenager, MD

    MS clinic, Department of Neurology, Sonderborg Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 28, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2008

Study Completion

June 1, 2008

Last Updated

August 12, 2008

Record last verified: 2008-08

Locations

DK(2)