- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01453868
The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis (NIA)
The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis
Standing Balance, with and without blindfold, will be measured on patients with Multiple Sclerosis using a Biodex Balance Scale.
A Twelve week intervention with one non impact aerobics group and one control group will be performed.
Standing balance will then be retested on all subjects and the results will be statistically compared.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Standing Balance will be tested in 4 phases:
- On a firm surface eyes open
- On a frim surface eyes blindfolded
- On a foam surface eyes open
- On a foam surface eyes blindfolded
The aerobics classes will be conducted by a NIA (Non Impact Aerobics) instructor and will be a combination of tai chi, slow movement dancing, stretching and modified yoga stretches.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Michigan
-
Gaylord, Michigan, United States, 49735
- Recruiting
- HealthZone Chiropractic Clinic
-
Contact:
- Donovan Adendorf, DC
- Phone Number: 989-731-2948
- Email: adendorf@msn.com
-
Contact:
- Donovan Adendorf, DC
- Phone Number: 989-732 1533
- Email: adendorff@hotmail.com
-
Principal Investigator:
- Donovan Adendorf, DC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients that were diagnosed by a neurologist with Relapsing Remitting Multiple Sclerosis.
- EDSS scale between 1 and 6.
- Patients that are able to travel to and from a 12 week program location.
Exclusion Criteria:
- Patients that were diagnosed by a neurologist with primary or secondary progressive multiple sclerosis.
- EDSS scale above 6
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active non impact aerobics
This group will be performing a 12 week non impact aerobics program twice a week.
|
a 12 week, twice a week class in non impact aerobics
Other Names:
|
Active Comparator: Control group: Passive lecture series
The control group will also be measured for balance and then attend a 12 week lecture series with no exercise.
They will then also be remeasured post lectures series
|
a 12 week, once a week for one hour lecture series with no exercise.
Topics will cover symptom management in Multiple Sclerosis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biodex Scale Balance score: Automated
Time Frame: Change: baseline and 12 weeks
|
A patient will step up to a Biodex Balance scale and will be instructed to try and maintain balance on the machine until it produces an automated outcome score for balance.
This number is directly related to a fall risk score in patients with neurological compromise.
|
Change: baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre and post intervention questionaire
Time Frame: Change: baseline and 12 weeks
|
A fifty question questionaire will be administered pre and post intervention.
These questions will focus on mood changes, attitude changes and overall quality of life changes related to adding exercise in their daily living.
|
Change: baseline and 12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Donovan Adendorf, DC, Nelson Mandela Metropole University, Department of Health Sciences
- Study Director: Rosa DuRandt, PhD, Professor: Human Movement Sciences, NMMU-Port Elizabeth South Africa
- Study Chair: Maryna Baard, PhD, Faculty of Helath Sciences-NMMU, Port Elizabeth South Africa
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H11-HEA-HMS-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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