NCT01216137

Brief Summary

The purpose of this study was to test the feasibility and effectiveness of a novel exercise intervention for individuals who live with multiple sclerosis (MS).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable multiple-sclerosis

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

Study Start

First participant enrolled

January 1, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

3.5 years

First QC Date

October 5, 2010

Last Update Submit

January 25, 2013

Conditions

Multiple SclerosisFatigueBalanceDizziness

Keywords

Multiple SclerosisFatigueBalanceUpright Postural ControlDizziness

Outcome Measures

Primary Outcomes (3)

  • Self-reported fatigue

    Modified Fatigue Impact Scale. Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.

    10 weeks

  • Upright postural control

    Sensory Organization Test (SOT)-Posturography. Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.

    10 weeks

  • Walking capacity

    6-minute walk test (6MWT). Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.

    10 weeks

Secondary Outcomes (2)

  • Self-reported dizziness

    10 weeks

  • Self-reported depression

    10 weeks

Study Arms (3)

Exercise: Vestibular Rehabilitation

EXPERIMENTAL

Balance and eye movement training

Other: Exercise: Vestibular Rehabilitation

Exercise Control

ACTIVE COMPARATOR

Bicycle ergometry and stretching

Other: Exercise

Wait-listed Control

NO INTERVENTION

Wait-listed Control

Interventions

Exercise: Vestibular RehabilitationOTHER

Balance and eye movement training

Exercise: Vestibular Rehabilitation
ExerciseOTHER

Bicycle ergometry and stretching

Exercise Control

Eligibility Criteria

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

You may qualify if:

  • (1) Clinically definite MS confirmed by a board certified Neurologist
  • (2) Kurtzke Expanded Disability Status Scale (EDSS) 0.0 to 6.0 (ranges and corresponding ambulatory status: 0.0 to 4.5 fully ambulatory without assistive device; 5.0 to 5.5 impaired ambulatory status without assistive device; 6.0 impaired ambulatory status with intermittent or unilateral constant assistive device)
  • (3) Age: 18 to 65 years (65 years has been set as the upper limit of age to decrease the possible age-related changes in physical strength, endurance, and upright postural control)
  • (4) Male or Female (MS affects both gender types)
  • (5) Comprehension of the general concept of the study and ability to make informed consent (see Section I. Special Consent Issues). (6) Minorities included
  • (7) Self-reported fatigue level on the Modified Fatigue Impact Scale (MFIS) of a total score \> 45 (This criterion has been used in previous studies investigating treatment for MS-related fatigue utilizing the MFIS)
  • (8) Sensory organization test (SOT) composite score of \< 72

You may not qualify if:

  • (1) Non-ambulatory
  • (2) Utilization of agents to control fatigue: i.e. medications: Amantadine, Pemoline, Dexedrine Amphetamine, Methylphenidate, Provigil, Ritalin, Prokarin.
  • (3) Utilization of medication(s) that have known possible side effects of fatigue such as: skeletal muscle relaxants (i.e. Baclofen, Zanaflex), Statin Drugs, pain medication (i.e. Opioids, tricyclic antidepressants (TCAs), anti-epileptic drugs (AEDs)
  • (4) Any other possible cause of fatigue: major sleep disorder, clinically diagnosed major depressive disorder, anemia, hypothyroidism, B12 deficiency, cancer
  • (5) Other neurological disorder which might contribute to significant balance problems, including cerebral vascular accident, peripheral neuropathy (separate from MS diagnosis, such as diabetes mellitus), peripheral vestibular disorders (unilateral/bilateral vestibular hypofunction: benign positional paroxysmal vertigo, Meniere's disease, acoustic neuroma)
  • (6) Change in MS specific medication (for disease modification) in the last three months
  • (7) Documented MS-related exacerbation in the last six months
  • (8) Any medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise testing and/or result in limitations for participation in an active exercise program or aerobic exercise program, as recommended by the American College of Sports Medicine (ACSM)
  • (9) Participation in an exercise routine specifically designed as a vestibular and/or aerobic exercise program within eight weeks prior to study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hebert JR, Corboy JR, Manago MM, Schenkman M. Effects of vestibular rehabilitation on multiple sclerosis-related fatigue and upright postural control: a randomized controlled trial. Phys Ther. 2011 Aug;91(8):1166-83. doi: 10.2522/ptj.20100399. Epub 2011 Jun 16.

    PMID: 21680771DERIVED

MeSH Terms

Conditions

Multiple SclerosisFatigueDizziness

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 SymptomsSensation DisordersNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Margaret Schenkman, PT, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 7, 2010

Study Start

January 1, 2007

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

January 29, 2013

Record last verified: 2013-01