Effects of Vestibular Rehabilitation on MS-related Fatigue: a Randomized Control Trial

This study has been completed.
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01216137
First received: October 5, 2010
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Multiple Sclerosis
Fatigue
Balance
Dizziness
Other: Exercise: Vestibular Rehabilitation
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Vestibular Rehabilitation on MS-related Fatigue and Upright Postural Control: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Self-reported fatigue [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.

  • Upright postural control [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.

  • Walking capacity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Self-reported dizziness [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Dizziness Handicap Inventory. 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.

  • Self-reported depression [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Beck Depression Inventory - II. 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.


Enrollment: 38
Study Start Date: January 2007
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise: Vestibular Rehabilitation
Balance and eye movement training
Other: Exercise: Vestibular Rehabilitation
Balance and eye movement training
Active Comparator: Exercise Control
Bicycle ergometry and stretching
Other: Exercise
Bicycle ergometry and stretching
No Intervention: Wait-listed Control
Wait-listed Control

Detailed Description:

The investigators investigated the effect of a vestibular exercise program designed to help people with MS with two common problems: fatigue and difficulties with balance while standing and walking. Our primary aim was to compare the results from persons with MS that participated in the vestibular exercises (Experimental group) to individuals who participated in a more typical rehabilitation exercise program consisting of stretching and endurance exercise (Exercise Control group) or people who did not receive exercise treatment (Control group).

The study was a 14-week randomized controlled trial. Thirty eighty participants were followed for four weeks before being randomly assigned to one of the three groups. Each participant had an equal chance of being assigned to either the Experimental group, Exercise Control group or the Control group. The Experimental group received a standardized vestibular exercise program that included upright postural control (balance) and eye movement exercises (6 one-hour sessions over 6 weeks). The Exercise Control group received endurance training using a stationary bicycle and leg stretching exercises (6 one-hour sessions over 6 weeks). Both exercise groups received the same 5 minutes of fatigue management education. Measurements of self-reported fatigue, dizziness and depression, and performance of a computerized, standing upright postural control test and walking capacity test were measured to determine benefits from the interventions. Participants in the Control group did not exercise, however if they chose, received the treatment within the clinical setting upon completion of their participation in the study.

The investigators hypothesized that: 1) participants in the Experimental group would improve significantly in fatigue and balance; 2) improvements found in the Experimental group would be significantly greater than improvements in the Exercise Control group and Control group.

Results: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (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

Exclusion Criteria:

  • (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216137

Sponsors and Collaborators
University of Colorado, Denver
National Multiple Sclerosis Society
Investigators
Principal Investigator: Margaret Schenkman, PT, PhD University of Colorado, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01216137     History of Changes
Other Study ID Numbers: 06-1108, PP1501
Study First Received: October 5, 2010
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Multiple Sclerosis
Fatigue
Balance
Upright Postural Control
Dizziness

Additional relevant MeSH terms:
Dizziness
Vertigo
Fatigue
Multiple Sclerosis
Sclerosis
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014