Status:
COMPLETED
Effects of Vestibular Rehabilitation on MS-related Fatigue: a Randomized Control Trial
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Multiple Sclerosis Society
Conditions:
Multiple Sclerosis
Fatigue
Eligibility:
All Genders
18-65 years
Phase:
NA
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).
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. O...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01216137
Start Date
January 1 2007
End Date
October 1 2010
Last Update
January 29 2013
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