Multiple Sclerosis, Relapsing-RemittingEarly Phase 1NIANCT01453868
The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis
A Early Phase 1 study testing Non Impact Aerobics and Passive : lecture series in people with Multiple Sclerosis, Relapsing-Remitting, run by Nelson Mandela Metropolitan University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Non Impact Aerobics and Passive : lecture series
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2012
- Phase
- Early Phase 1
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients that were diagnosed by a neurologist with primary or secondary progressive multiple sclerosis.
- EDSS scale above 6
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
HealthZone Chiropractic Clinic
Gaylord, Michigan, 49735
Donovan Adendorf, DC, 989-731-2948, adendorf@msn.com
Donovan Adendorf, DC, 989-732 1533, adendorff@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Non Impact Aerobics, Passive : lecture series
- Keywords
- Multiple Sclerosis, non impact aerobics
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Impact AerobicsOther
Also called Dancing, NIA, MS
a 12 week, twice a week class in non impact aerobics
Passive : lecture seriesOther
Also called Lifestyle lectures, symptom management
a 12 week, once a week for one hour lecture series with no exercise. Topics will cover symptom management in Multiple Sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Active non impact aerobics | Active comparator | This group will be performing a 12 week non impact aerobics program twice a week. Receives: Other: Non Impact Aerobics |
| Control group: Passive lecture series | Active comparator | 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 Receives: Other: Passive : lecture series |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change: baseline and 12 weeks
Secondary outcomes (1)
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.
Measured: Change: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nelson Mandela Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Donovan Adendorf, Nelson Mandela Metropolitan University
- Investigators
- Donovan Adendorf, DC, Principal investigator, Nelson Mandela Metropole University, Department of Health SciencesRosa DuRandt, PhD, Study director, Professor: Human Movement Sciences, NMMU-Port Elizabeth South AfricaMaryna Baard, PhD, Study chair, Faculty of Helath Sciences-NMMU, Port Elizabeth South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453868
- Sponsor's protocol ID
- H11-HEA-HMS-002
- Acronym
- NIA
- Status last verified
- Oct 2011
- First submitted
- 13 Oct 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01453868
- Acronym / sponsor ID
- NIA / H11-HEA-HMS-002
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, non impact aerobics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nelson Mandela Metropolitan UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 18 Oct 2011 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active non impact aerobics | Active comparator | Other: Non Impact AerobicsThis group will be performing a 12 week non impact aerobics program twice a week. |
| Control group: Passive lecture series | Active comparator | Other: Passive : lecture seriesThe 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients that were diagnosed by a neurologist with primary or secondary progressive multiple sclerosis.
- EDSS scale above 6
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 |
|---|---|---|
| Non Impact AerobicsAlso: Dancing, NIA, MSa 12 week, twice a week class in non impact aerobics | Other | Active non impact aerobics |
| Passive : lecture seriesAlso: Lifestyle lectures, symptom managementa 12 week, once a week for one hour lecture series with no exercise. Topics will cover symptom management in Multiple Sclerosis | Other | Control group: Passive lecture series |
Primary outcome
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.
1 secondary outcome
Pre and post intervention questionaire
Time frame: Change: baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2011.
- Nelson Mandela Metropole University, Port Elizabeth South AfricaLink provided by the sponsor.
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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.
Donovan Adendorf, DC principal investigator
Nelson Mandela Metropole University, Department of Health Sciences
Rosa DuRandt, PhD study director
Professor: Human Movement Sciences, NMMU-Port Elizabeth South Africa
Maryna Baard, PhD study chair
Faculty of Helath Sciences-NMMU, Port Elizabeth South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Non Impact Aerobics and Passive : lecture series in people with Multiple Sclerosis, Relapsing-Remitting, run by Nelson Mandela Metropolitan University at 1 site in United States.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donovan Adendorf, DC (989-731 2948, adendorf@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Scale Balance score: Automated (time frame: Change: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2011.