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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Nelson Mandela Metropolitan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Donovan Adendorf, Nelson Mandela Metropolitan University
ClinicalTrials.gov Identifier:
NCT01453868
First received: October 13, 2011
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Other: Non Impact Aerobics
Other: Passive : lecture series
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Nelson Mandela Metropolitan University:

Primary Outcome Measures:
  • Biodex Scale Balance score: Automated [ Time Frame: Change: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Change: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active non impact aerobics
This group will be performing a 12 week non impact aerobics program twice a week.
Other: Non Impact Aerobics
a 12 week, twice a week class in non impact aerobics
Other Name: Dancing, NIA, MS
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
Other: Passive : lecture series
a 12 week, once a week for one hour lecture series with no exercise. Topics will cover symptom management in Multiple Sclerosis
Other Name: Lifestyle lectures, symptom management

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453868

Contacts
Contact: Donovan Adendorf, DC 989-731 2948 adendorf@msn.com
Contact: Donovan Adendorf 989-858 2345 adendorf@msn.com

Locations
United States, Michigan
HealthZone Chiropractic Clinic Recruiting
Gaylord, Michigan, United States, 49735
Contact: Donovan Adendorf, DC    989-731-2948    adendorf@msn.com   
Contact: Donovan Adendorf, DC    989-732 1533    adendorff@hotmail.com   
Principal Investigator: Donovan Adendorf, DC         
Sponsors and Collaborators
Nelson Mandela Metropolitan University
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Donovan Adendorf, Dr Donovan Adendorf, Nelson Mandela Metropolitan University
ClinicalTrials.gov Identifier: NCT01453868     History of Changes
Other Study ID Numbers: H11-HEA-HMS-002
Study First Received: October 13, 2011
Last Updated: October 17, 2011
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by Nelson Mandela Metropolitan University:
Multiple Sclerosis
non impact aerobics

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014