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

25 januari 2013 bijgewerkt door: University of Colorado, Denver

The Effects of Vestibular Rehabilitation on MS-related Fatigue and Upright Postural Control: a Randomized Controlled Trial

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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

38

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Exercise: Vestibular Rehabilitation
Balance and eye movement training
Ander: Exercise: Vestibular Rehabilitation
Balance and eye movement training
Actieve vergelijker: Exercise Control
Bicycle ergometry and stretching
Ander: Exercise
Bicycle ergometry and stretching
Geen tussenkomst: Wait-listed Control

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-reported fatigue
Tijdsspanne: 10 weeks
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
Tijdsspanne: 10 weeks
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
Tijdsspanne: 10 weeks
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-reported dizziness
Tijdsspanne: 10 weeks
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.
10 weeks
Self-reported depression
Tijdsspanne: 10 weeks
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.
10 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Colorado, Denver

Medewerkers

National Multiple Sclerosis Society

Onderzoekers

  • Hoofdonderzoeker: Margaret Schenkman, PT, PhD, University of Colorado, Denver

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2007

Primaire voltooiing (Werkelijk)

1 juli 2010

Studie voltooiing (Werkelijk)

1 oktober 2010

Studieregistratiedata

Eerst ingediend

5 oktober 2010

Eerst ingediend dat voldeed aan de QC-criteria

6 oktober 2010

Eerst geplaatst (Schatting)

7 oktober 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

29 januari 2013

Laatste update ingediend die voldeed aan QC-criteria

25 januari 2013

Laatst geverifieerd

1 januari 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 06-1108
  • PP1501 (Ander subsidie-/financieringsnummer: National Multiple Sclerosis Society Pilot Research Award)

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