Multiple SclerosisNCT03429062
Comparison of Two Community Based Exercise Protocols in People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Texas Woman's University at 1 site in United States.
Trial summary
This study will compare the benefits of two community based exercise programs, personal training and whole body vibration on balance and gait in people with Multiple Sclerosis. Anyone with a diagnosis of MS can participate in the personal training. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Personal training exercises
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 13 Feb 2019
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes adults (18-85 years) with a diagnosis of Multiple Sclerosis. This is a sample of convenience, with recruitment occurring at MindSet Fitness and Yoga where exercise classes for people with MS occur every Tuesday and Thursday.
Who may be able to join
- Definite diagnosis of MS,
- able to read, understand and sign the consent to participate form,
- adults between 18 and 85 years,
- attend a pre and post test session of 60-120 minutes
Who cannot join
- unable to read, understand the consent to participate form,
- unable to participate in any exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Community Based Personal Training to Whole Body Vibration on Balance and Gait Parameters in People With Multiple Sclerosis
This study will compare the benefits of two community based exercise programs, personal training and whole body vibration on balance and gait in people with Multiple Sclerosis. Anyone with a diagnosis of MS can participate in the personal training. Only people who can walk with or without an assistive device with a diagnosis of MS can participate in the Whole Body Vibration. Pre testing and post testing will be completed using balance and gait measures and self reporting measures for balance confidence and impact of MS. The program will run two times per week for six weeks.
Read the detailed description
Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that affects approximately 400,000 persons in the United States, and 1,200,000 persons between 16 and 65 years of age worldwide. It is a neurodegenerative pathology which can be characterized by a course of demyelination-mediated relapses and remissions, superimposed upon gradual neurologic deterioration, resulting in a clinical course that is unpredictable in its progression and severity. The pathophysiology associated with MS is the slowing or stopping of saltatory conduction of action potentials along myelinated axons in the CNS. This results in a clinical presentation that is varied and unpredictable in age of onset, disease progression, and the signs and symptoms experienced by each person with MS (PWMS).
Individuals with Multiple Sclerosis have a variety of symptoms before and after diagnosis. Common symptoms include double vision, partial loss of vision, numbness or weakness of the limbs, fatigue, depression, cognitive dysfunction, dizziness, tremor, decreased coordination, and unsteady gait. Many symptoms of MS are associated with increased fall risk similar to that found in older individuals.
The purpose of this study is to use and compare two different interventions in people with MS in a community setting. The first intervention is an assisted personal training program offered in a community setting to improve functional limitations and reduce risk for falls in people with MS. This exercise program will be provided by personal trainers educated in exercise training in people with MS. The personal training program is an ongoing program supported by the National MS Society. The second intervention is the use of Whole Body Vibration (WBV) platforms to improve gait ability and improve balance in people with MS.
Assisted personal training, circuit training has limited research in people with MS. This method of exercise is similar to exercise healthy individuals would complete in a fitness center setting with guidance from a personal trainer. In this study, the personal training program will be provided by educated personal trainers. These personal trainers completed a 24 hour continuing education course on exercise in people with neurodegenerative diseases. The facility, MindSet Charities has a strong ongoing personal training program for people with MS, and this program is supported by the National Multiple Sclerosis Society (NMSS). The individuals with MS attend 2 personal training sessions each week. The effectiveness of this type of program has not been studied to date.
There is a desire to improve training options to increase endurance, gait ability, and balance in people with MS. In the past decade whole body vibration has been studied in athletes, older individuals, people with chronic stroke, people with Parkinson Disease, and there are a few studies in people with MS. During WBV training, individuals stand on the platform and complete a series of exercises designed to improve gait ability and balance. The vertical vibrations during the session are thought to cause muscle contractions initiated by sensory receptors and reduce the recruitment threshold of motor units possibly resulting in increased activation of high threshold fast twitch muscle fibers.
Hypothesis:1. Individuals with MS who participate in either a personal training class or a WBV exercise protocol will have improvements in gait, balance, endurance, fatigue, and quality of life (QOL). 2. Individuals in the WBV training group will have a greater improvement in strength.
- Conditions
- Multiple Sclerosis
- Being tested
- Personal training exercises
- Keywords
- balance, gait, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal training exercisesOther
Also called whole body vibration platform exercise
Personal training: strengthening, stretching, endurance, balance Whole body vibration: strengthening, balance, stretching, endurance, balance
| Study group | Role | What they receive |
|---|---|---|
| personal training | Individuals with a diagnosis of MS and any level of function will be recruited to participate in exercise two times per week with trained personal trainers. Exercise consists of strengthening, stretching, balance, endurance and gait when able. Equipment to be used include treadmill, stationary bike, weight equipment. Receives: Other: Personal training exercises | |
| Whole Body Platform | Individuals with a diagnosis of MS and able to walk with or without an assistive device will be recruited to participate in whole body platform training two times per week with a physical therapist. The exercise on the whole body platform includes strengthening, balance, stretching, and endurance for 30 second bouts. The whole body platform is on for 30 seconds then off. Each exercise will use the 30 seconds to complete. Receives: Other: Personal training exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Balance Evaluations Systems Test (MiniBEST Test)
Measure of dynamic balance, scores range from 0 (no Balance) to 28 good dynamic balance.
Measured: 20 minutes
Secondary outcomes (6)
Activities Specific Balance Scale
self report balance confidence, score from 0% (no confidence in balance) to 100% (full confidence in balance)
Measured: 15 minutes
Fatigue Severity Scale
self report fatigue measure, scale goes from 1 (strongly agree with the statement about fatigue) to 7 (strongly disagree with statement about fatigue) higher score indicates less MS fatigue.
Measured: 10 minutes
Multiple Sclerosis Impact Scale
Quality of life measure that measures the impact MS has on the persons day to day life. The scale ranges from 1 (not at all impactful) to 5 (extremely impactful), Scores range from 29 to 145. The higher the score the more they are impacted by MS in day to day life.
Measured: 15 minutes
Dynamic Gait Index
Measure of gait, scale goes from 3 (normal) to 0 (unable) and range is 24 indicates normal gait, 0 indicates unable to walk, risk for falls is less than or equal to 19/24.
Measured: 15 minutes
5 Times Sit to Stand Test
Measure of strength and power, timed test, how long does it take to go from sit to stand, less than 15 secs is risk for falls.
Measured: 1 minute
2 Minute Walk test
measure of gait endurance, how far can the person walk in 2 minutes. Normal values 176-189 meters
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start13 Feb 2018
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Why it stopped: retirement of faculty PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda A Csiza, PT, DSc, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429062
- Sponsor's protocol ID
- 19517
- Status last verified
- Sep 2019
- First submitted
- 5 Feb 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Community Based Personal Training to Whole Body Vibration on Balance and Gait Parameters in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03429062
- Acronym / sponsor ID
- 19517
- Conditions
- Multiple Sclerosis
- Keywords
- balance, gait, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: retirement of faculty PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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.
This study will compare the benefits of two community based exercise programs, personal training and whole body vibration on balance and gait in people with Multiple Sclerosis. Anyone with a diagnosis of MS can participate in the personal training. Only people who can walk with or without an assistive device with a diagnosis of MS can participate in the Whole Body Vibration. Pre testing and post testing will be completed using balance and gait measures and self reporting measures for balance confidence and impact of MS. The program will run two times per week for six weeks.
Detailed description
Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that affects approximately 400,000 persons in the United States, and 1,200,000 persons between 16 and 65 years of age worldwide. It is a neurodegenerative pathology which can be characterized by a course of demyelination-mediated relapses and remissions, superimposed upon gradual neurologic deterioration, resulting in a clinical course that is unpredictable in its progression and severity. The pathophysiology associated with MS is the slowing or stopping of saltatory conduction of action potentials along myelinated axons in the CNS. This results in a clinical presentation that is varied and unpredictable in age of onset, disease progression, and the signs and symptoms experienced by each person with MS (PWMS).
Individuals with Multiple Sclerosis have a variety of symptoms before and after diagnosis. Common symptoms include double vision, partial loss of vision, numbness or weakness of the limbs, fatigue, depression, cognitive dysfunction, dizziness, tremor, decreased coordination, and unsteady gait. Many symptoms of MS are associated with increased fall risk similar to that found in older individuals.
The purpose of this study is to use and compare two different interventions in people with MS in a community setting. The first intervention is an assisted personal training program offered in a community setting to improve functional limitations and reduce risk for falls in people with MS. This exercise program will be provided by personal trainers educated in exercise training in people with MS. The personal training program is an ongoing program supported by the National MS Society. The second intervention is the use of Whole Body Vibration (WBV) platforms to improve gait ability and improve balance in people with MS.
Assisted personal training, circuit training has limited research in people with MS. This method of exercise is similar to exercise healthy individuals would complete in a fitness center setting with guidance from a personal trainer. In this study, the personal training program will be provided by educated personal trainers. These personal trainers completed a 24 hour continuing education course on exercise in people with neurodegenerative diseases. The facility, MindSet Charities has a strong ongoing personal training program for people with MS, and this program is supported by the National Multiple Sclerosis Society (NMSS). The individuals with MS attend 2 personal training sessions each week. The effectiveness of this type of program has not been studied to date.
There is a desire to improve training options to increase endurance, gait ability, and balance in people with MS. In the past decade whole body vibration has been studied in athletes, older individuals, people with chronic stroke, people with Parkinson Disease, and there are a few studies in people with MS. During WBV training, individuals stand on the platform and complete a series of exercises designed to improve gait ability and balance. The vertical vibrations during the session are thought to cause muscle contractions initiated by sensory receptors and reduce the recruitment threshold of motor units possibly resulting in increased activation of high threshold fast twitch muscle fibers.
Hypothesis:1. Individuals with MS who participate in either a personal training class or a WBV exercise protocol will have improvements in gait, balance, endurance, fatigue, and quality of life (QOL). 2. Individuals in the WBV training group will have a greater improvement in strength.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| personal training | – | Other: Personal training exercisesIndividuals with a diagnosis of MS and any level of function will be recruited to participate in exercise two times per week with trained personal trainers. Exercise consists of strengthening, stretching, balance, endurance and gait when able. Equipment to be used include treadmill, stationary bike, weight equipment. |
| Whole Body Platform | – | Other: Personal training exercisesIndividuals with a diagnosis of MS and able to walk with or without an assistive device will be recruited to participate in whole body platform training two times per week with a physical therapist. The exercise on the whole body platform includes strengthening, balance, stretching, and endurance for 30 second bouts. The whole body platform is on for 30 seconds then off. Each exercise will use the 30 seconds to complete. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adults (18-85 years) with a diagnosis of Multiple Sclerosis. This is a sample of convenience, with recruitment occurring at MindSet Fitness and Yoga where exercise classes for people with MS occur every Tuesday and Thursday.
Key inclusion criteria (4 listed)
- Definite diagnosis of MS,
- able to read, understand and sign the consent to participate form,
- adults between 18 and 85 years,
- attend a pre and post test session of 60-120 minutes
Key exclusion criteria (2 listed)
- unable to read, understand the consent to participate form,
- unable to participate in any exercise
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 |
|---|---|---|
| Personal training exercisesAlso: whole body vibration platform exercisePersonal training: strengthening, stretching, endurance, balance Whole body vibration: strengthening, balance, stretching, endurance, balance | Other | Whole Body Platform, personal training |
Primary outcome
Mini Balance Evaluations Systems Test (MiniBEST Test)
Time frame: 20 minutes
Measure of dynamic balance, scores range from 0 (no Balance) to 28 good dynamic balance.
6 secondary outcomes
Activities Specific Balance Scale
Time frame: 15 minutes
Fatigue Severity Scale
Time frame: 10 minutes
Multiple Sclerosis Impact Scale
Time frame: 15 minutes
Dynamic Gait Index
Time frame: 15 minutes
5 Times Sit to Stand Test
Time frame: 1 minute
2 Minute Walk test
Time frame: 2 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Linda A Csiza, PT, DSc principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Texas Woman's 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 4 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: withdrawn, as of the sponsor's last update on 17 Sep 2019. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Balance Evaluations Systems Test (MiniBEST Test) (time frame: 20 minutes). 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 17 Sep 2019.