NCT01074827

Brief Summary

The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

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

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

February 23, 2010

Last Update Submit

July 6, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisWalking abilityStrengthBalanceTreadmill walking

Outcome Measures

Primary Outcomes (1)

  • Walking ability

    8 weeks

Secondary Outcomes (3)

  • Strength

    8 weeks

  • Work economy O2

    8 weeks

  • Balance

    8 weeks

Study Arms (2)

Treadmill group

EXPERIMENTAL

Specific gait training on treadmill

Other: Strength training and treadmill training

Strength training group

EXPERIMENTAL

Eight weeks of intensive strength training

Other: Strength training and treadmill training

Interventions

Strength training and treadmill trainingOTHER

Eight weeks of intensive strength training or treadmill training

Strength training groupTreadmill group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive
  • Expanded Disability Status Scale (EDSS)score of ≤ 6
  • Reduced walking ability (subjectively experienced)

You may not qualify if:

  • persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training.
  • spasticity requiring stretching og treatment with baclofen.
  • Other, not MS-related, conditions affecting walking ability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Braendvik SM, Koret T, Helbostad JL, Loras H, Brathen G, Hovdal HO, Aamot IL. Treadmill Training or Progressive Strength Training to Improve Walking in People with Multiple Sclerosis? A Randomized Parallel Group Trial. Physiother Res Int. 2016 Dec;21(4):228-236. doi: 10.1002/pri.1636. Epub 2015 Jun 25.

    PMID: 26110230RESULT

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

  • Siri M, Brændvik

    St. Olavs 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

February 23, 2010

First Posted

February 24, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

NO(1)