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The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis (NIA)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Non Impact Aerobics
Passive : lecture series
Sponsored by
Nelson Mandela Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple Sclerosis, non impact aerobics

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HealthZone Chiropractic ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Active non impact aerobics

Control group: Passive lecture series

Arm Description

This group will be performing a 12 week non impact aerobics program twice a week.

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

Outcomes

Primary Outcome Measures

Biodex Scale Balance score: Automated
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.

Secondary Outcome Measures

Pre and post intervention questionaire
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.

Full Information

First Posted
October 13, 2011
Last Updated
October 17, 2011
Sponsor
Nelson Mandela Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT01453868
Brief Title
The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis
Acronym
NIA
Official Title
The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nelson Mandela Metropolitan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple Sclerosis, non impact aerobics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active non impact aerobics
Arm Type
Active Comparator
Arm Description
This group will be performing a 12 week non impact aerobics program twice a week.
Arm Title
Control group: Passive lecture series
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Non Impact Aerobics
Other Intervention Name(s)
Dancing, NIA, MS
Intervention Description
a 12 week, twice a week class in non impact aerobics
Intervention Type
Other
Intervention Name(s)
Passive : lecture series
Other Intervention Name(s)
Lifestyle lectures, symptom management
Intervention Description
a 12 week, once a week for one hour lecture series with no exercise. Topics will cover symptom management in Multiple Sclerosis
Primary Outcome Measure Information:
Title
Biodex Scale Balance score: Automated
Description
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.
Time Frame
Change: baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Pre and post intervention questionaire
Description
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.
Time Frame
Change: baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donovan Adendorf, DC
Phone
989-731 2948
Email
adendorf@msn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Donovan Adendorf
Phone
989-858 2345
Email
adendorf@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donovan Adendorf, DC
Organizational Affiliation
Nelson Mandela Metropole University, Department of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosa DuRandt, PhD
Organizational Affiliation
Professor: Human Movement Sciences, NMMU-Port Elizabeth South Africa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maryna Baard, PhD
Organizational Affiliation
Faculty of Helath Sciences-NMMU, Port Elizabeth South Africa
Official's Role
Study Chair
Facility Information:
Facility Name
HealthZone Chiropractic Clinic
City
Gaylord
State/Province
Michigan
ZIP/Postal Code
49735
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donovan Adendorf, DC
Phone
989-731-2948
Email
adendorf@msn.com
First Name & Middle Initial & Last Name & Degree
Donovan Adendorf, DC
Phone
989-732 1533
Email
adendorff@hotmail.com
First Name & Middle Initial & Last Name & Degree
Donovan Adendorf, DC

12. IPD Sharing Statement

Links:
URL
http://www.nmmu.ac.za/
Description
Nelson Mandela Metropole University, Port Elizabeth South Africa

Learn more about this trial

The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis

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