Multiple SclerosisNCT01216137
Effects of Vestibular Rehabilitation on MS-related Fatigue: a Randomized Control Trial
A study testing Exercise: Vestibular Rehabilitation and Exercise in people with Multiple Sclerosis and Fatigue, run by University of Colorado, Denver.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue, Balance
- What is being tested?
- Exercise: Vestibular Rehabilitation and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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
Show all 9Show fewer
- (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.
About this study
Official title: 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).
Read the 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.
- Conditions
- Multiple Sclerosis, Fatigue, Balance, Dizziness
- Being tested
- Exercise: Vestibular Rehabilitation, Exercise
- Keywords
- Multiple Sclerosis, Fatigue, Balance, Upright Postural Control, Dizziness
- Medical subject headings
- Multiple Sclerosis, Fatigue, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise: Vestibular RehabilitationOther
Balance and eye movement training
ExerciseOther
Bicycle ergometry and stretching
| Study group | Role | What they receive |
|---|---|---|
| Exercise: Vestibular Rehabilitation | Experimental | Balance and eye movement training Receives: Other: Exercise: Vestibular Rehabilitation |
| Exercise Control | Active comparator | Bicycle ergometry and stretching Receives: Other: Exercise |
| Wait-listed Control | No intervention | Wait-listed Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (2)
Self-reported dizziness
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.
Measured: 10 weeks
Self-reported depression
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJan 2007
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Margaret Schenkman, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216137
- Sponsor's protocol ID
- 06-1108
- Other IDs
- PP1501
- Status last verified
- Jan 2013
- First submitted
- 5 Oct 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21680771
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vestibular Rehabilitation on MS-related Fatigue and Upright Postural Control: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01216137
- Acronym / sponsor ID
- 06-1108
- Conditions
- Multiple Sclerosis, Fatigue, Balance, Dizziness
- Keywords
- Multiple Sclerosis, Fatigue, Balance, Upright Postural Control, Dizziness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Jan 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise: Vestibular Rehabilitation | Experimental | Other: Exercise: Vestibular RehabilitationBalance and eye movement training |
| Exercise Control | Active comparator | Other: ExerciseBicycle ergometry and stretching |
| Wait-listed Control | No intervention | –Wait-listed Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (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
Key exclusion criteria (9 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise: Vestibular RehabilitationBalance and eye movement training | Other | Exercise: Vestibular Rehabilitation |
| ExerciseBicycle ergometry and stretching | Other | Exercise Control |
Primary outcome
Self-reported fatigue
Time frame: 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.
Upright postural control
Time frame: 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.
Walking capacity
Time frame: 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.
2 secondary outcomes
Self-reported dizziness
Time frame: 10 weeks
Self-reported depression
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
- Derived from this study: PubMed 21680771Hebert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Schenkman, PT, PhD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Exercise: Vestibular Rehabilitation and Exercise in people with Multiple Sclerosis and Fatigue, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported fatigue (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01216137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.