NCT01122056

Brief Summary

The purpose of this study is to investigate the effects and tolerability of exercise on side effects of injectable disease modifying treatments in multiple sclerosis. The investigators main hypothesis is that controlled exercise is safe and can be well tolerated in patients with multiple sclerosis and it can improve disease modifying treatment related side effects such as fatigue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2010

Typical duration for not_applicable multiple-sclerosis

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

May 10, 2010

Last Update Submit

March 1, 2017

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosisb1b-interferonFatigueExercise

Outcome Measures

Primary Outcomes (3)

  • Multiple Sclerosis Fatigue

  • Quality of Life

  • Injection site visual analog scale (0-10)

Study Arms (2)

A = Active group

ACTIVE COMPARATOR

Patients will receive interactive exercise training session from an experienced multiple sclerosis

Other: Physical exercise training

B = Control group (Placebo Comparator)

NO INTERVENTION

Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis.

Interventions

Physical exercise trainingOTHER

Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis

Also known as: Betaseron b1b-interferon, Aerobic exercise
A = Active group

Eligibility Criteria

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

You may qualify if:

  • Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Coastal Health: University of British Columbia Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Multiple SclerosisFatigueMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Laura Boyd

    University of British Columbia

    STUDY DIRECTOR

  • Kristen Campbell

    University of British Columbia

    STUDY DIRECTOR

  • Saul Isserow

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

CA(1)