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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— NIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01453868
• Other study ID #: H11-HEA-HMS-002
• Status: Recruiting
• Phase: Phase 0
• First received: October 13, 2011
• Last updated: October 17, 2011
• Start date: October 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2011
• Source: Nelson Mandela Metropolitan University
• Contact: Donovan Adendorf, DC
• Phone: 989-731 2948
• Email: adendorf[@]msn.com
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Other:
• Non Impact Aerobics
a 12 week, twice a week class in non impact aerobics
• 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

Locations

Country	Name	City	State
United States	HealthZone Chiropractic Clinic	Gaylord	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Nelson Mandela Metropolitan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change: baseline and 12 weeks	Yes
Secondary	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.	Change: baseline and 12 weeks	No

External Links

•   Nelson Mandela Metropole University, Port Elizabeth South Africa