Multiple SclerosisNCT01993095
FlexToBa for People With Multiple Sclerosis
A study testing Home-based, DVD-delivered physical activity in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a DVD-delivered, home-based six-month physical activity intervention for people with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Home-based, DVD-delivered physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2014
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being non-active, defined as reporting not engaging in regular activity (30 minutes accumulated per day) on more than two days of the week in the prior six months;
- aged 50 years and older;
- fluent in English;
- relapse-free in the last 30 days;
- ambulatory with minimal assistance(i.e., walk independently or with a single-point assistive walking device such as a cane);
- the provision of medical clearance for participation in a physical activity program by participants' physicians, along with a physician-confirmed diagnosis of MS (communication with physicians will be facilitated by research staff).
Who cannot join
- self-reported physical activity on a regular basis within the last six months (2 times or more per week);
- younger than 50 years of age;
- relapse in the last 30 days;
- no regular access to a television;
- no physician-confirmed diagnosis of multiple sclerosis;
- unable to successfully score above 21 (out of 39)on the Telephone Interview of Cognitive Status questionnaire (TICS-M).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
The purpose of this study is to test the effectiveness of a DVD-delivered, home-based six-month physical activity intervention for people with Multiple Sclerosis.
Read the detailed description
Persons with MS are less likely to be active than their healthy counterparts, a statistic that is compounded by the symptom manifestations of MS. However, there is increasing evidence to support the importance of physical activity in MS. Unfortunately, structured, safe, and efficacious physical activity programs that are often conducted in medical or university settings are often not accessible to many older adults with or without MS. We propose to conduct a randomized controlled pilot trial testing the efficacy of a DVD-delivered physical activity intervention which targets factors that have the potential to reduce disability in older adults with MS. This DVD-based intervention has been previously approved by the IRB at the University of Illinois for a similar study with low-active, community-dwelling older adults (IRB Protocol Number: 09765). This novel intervention provides systematic, programmatic activities with alternative versions of each exercise that allow individuals of all capabilities to complete the program successfully. It focuses on improving flexibility, strength, and balance and has been demonstrated to be feasible, well-accepted, and efficacious in a large sample of older adults without MS. Importantly, intervention resulted in clinically significant improvements in the Short Physical Performance Battery, reliable determinant of disability, institutionalization, morbidity, and mortality. If such an intervention was equally successful in older persons with MS, this could have considerable public health impact.
- Conditions
- Multiple Sclerosis
- Being tested
- Home-based, DVD-delivered physical activity, Behavioral: Usual care/Wait list
- Keywords
- Multiple Sclerosis, Quality of Life, Functional Fitness
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based, DVD-delivered physical activityBehavioural
Subjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance. Exercises will be progressive over the six-months and will highlight modifications for varying levels. This program will be delivered on 3 DVDs. Participants will be asked to exercise with the DVD at least three times per week.
Behavioral: Usual care/Wait listBehavioural
Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: FlexToBa physical activity DVD | Experimental | Participants in this arm will receive a physical activity program delivered by DVD that focuses on exercises targeting flexibility, toning and balance. These exercises will be progressive in nature throughout the six months and will also focus on modifications for all ability levels. Participants will be provided with three DVDs including: an Introduction to physical activity, Sessions 1-3, and Sessions 4-6, which they will be asked to watch and participate in over the course of six months. Receives: Behavioral: Home-based, DVD-delivered physical activity |
| Usual care-Wait list | Active comparator | Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing. Receives: Behavioral: Behavioral: Usual care/Wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
The measurements will include:
Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance
Measured: Baseline and six months
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Measurements will include:
Timed 20-foot walk test -- walk 25 feet as quickly as possible;
Measured: Baseline and six-months
Change in assessments of functional fitness assessments in sedentary adults with MS
Measurements will include:
6-minute walk test -- walk as much as possible (in terms of distance) for 6 minutes;
Measured: Baseline and six-months
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Measurements will include:
Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength;
Measured: Baseline and six-months
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Measurements will include:
Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility)
Measured: Baseline and six-months
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Measurements will include:
Upper body strength -- bicep curls consisting of lifting a light hand-weight as many times as possible in 30-seconds;
Measured: Baseline and six-months
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Measurements will include:
Balance -- a timed (up to 30-seconds) unassisted one-leg stand test with eyes open on each leg.
Measured: Baseline and six-months
Change from baseline to six-months in assessments of reported quality of life in people with MS
The Leeds Multiple Sclerosis Quality of Life Scale will be used as a disease specific quality of life measure for people with MS.
Measured: Baseline and six months
Change from baseline to six-months in assessments of reported quality of life in people with MS
The Satisfaction with Life Scale will be used to assess global life satisfaction and is sensitive enough to detect changes in participants' perceptions over the course of a clinical intervention.
Measured: Baseline and six-months
Secondary outcomes (8)
Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
Measured: Baseline and six months
Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
Participants' situation-specific self-confidence for physical activity will be assessed using The Barriers Self-Efficacy Scale, which taps subjects' perceived capabilities to exercise three times per week for 40 minutes over the next two months in the face of commonly identified barriers to participation.
Measured: Baseline and six months
Changes in physical activity relating to specified exercise program in sedentary adults with MS
Adherence to exercise program as documented by daily exercise logs.
Measured: Baseline and six months
Objective changes in physical activity in sedentary adults with MS
Objective assessment of physical activity via accelerometry over seven days time.
Measured: Baseline and six months
Self-reported changes in physical activity in sedentary adults with MS
Subjective assessment of physical activity via the Godin Leisure Time Exercise Questionnaire, which assesses frequency of involvement in strenuous, moderate and light activities.
Measured: Baseline and six months
Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
Participants' situation-specific self-confidence for physical activity will be assessed using The Gait Self-Efficacy Scale, which will assess participants' beliefs in their capabilities to negotiate stairs and objects in their path.
Measured: Baseline and six-months
Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
The Exercise Self-Efficacy Scale will assess participants' beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future.
Measured: Baseline and six-months
Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
Walking Self-Efficacy Scale for Duration will assess participants' beliefs in their physical capability to successfully complete incremental 5-minute intervals (up to 40 minutes)of walking at a moderately fast pace.
Measured: Baseline and six-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Edward McAuley, University of Illinois at Urbana-Champaign
- Investigators
- Edward McAuley, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993095
- Sponsor's protocol ID
- IL-0009
- Status last verified
- Feb 2017
- First submitted
- 18 Oct 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wojcicki TR, Roberts SA, Learmonth YC, Hubbard EA, Kinnett-Hopkins D, Motl RW, McAuley E. Improving physical functional and quality of life in older adults with multiple sclerosis via a DVD-delivered exercise intervention: a study protocol. BMJ Open. 2014 Dec 1;4(12):e006250. doi: 10.1136/bmjopen-2014-006250.
PubMed 25448627
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
- ClinicalTrials.gov ID
- NCT01993095
- Acronym / sponsor ID
- IL-0009
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Quality of Life, Functional Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Nov 2013 (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.
The purpose of this study is to test the effectiveness of a DVD-delivered, home-based six-month physical activity intervention for people with Multiple Sclerosis.
Detailed description
Persons with MS are less likely to be active than their healthy counterparts, a statistic that is compounded by the symptom manifestations of MS. However, there is increasing evidence to support the importance of physical activity in MS. Unfortunately, structured, safe, and efficacious physical activity programs that are often conducted in medical or university settings are often not accessible to many older adults with or without MS. We propose to conduct a randomized controlled pilot trial testing the efficacy of a DVD-delivered physical activity intervention which targets factors that have the potential to reduce disability in older adults with MS. This DVD-based intervention has been previously approved by the IRB at the University of Illinois for a similar study with low-active, community-dwelling older adults (IRB Protocol Number: 09765). This novel intervention provides systematic, programmatic activities with alternative versions of each exercise that allow individuals of all capabilities to complete the program successfully. It focuses on improving flexibility, strength, and balance and has been demonstrated to be feasible, well-accepted, and efficacious in a large sample of older adults without MS. Importantly, intervention resulted in clinically significant improvements in the Short Physical Performance Battery, reliable determinant of disability, institutionalization, morbidity, and mortality. If such an intervention was equally successful in older persons with MS, this could have considerable public health impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: FlexToBa physical activity DVD | Experimental | Behavioral: Home-based, DVD-delivered physical activityParticipants in this arm will receive a physical activity program delivered by DVD that focuses on exercises targeting flexibility, toning and balance. These exercises will be progressive in nature throughout the six months and will also focus on modifications for all ability levels. Participants will be provided with three DVDs including: an Introduction to physical activity, Sessions 1-3, and Sessions 4-6, which they will be asked to watch and participate in over the course of six months. |
| Usual care-Wait list | Active comparator | Behavioral: Behavioral: Usual care/Wait listParticipants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being non-active, defined as reporting not engaging in regular activity (30 minutes accumulated per day) on more than two days of the week in the prior six months;
- aged 50 years and older;
- fluent in English;
- relapse-free in the last 30 days;
- ambulatory with minimal assistance(i.e., walk independently or with a single-point assistive walking device such as a cane);
Key exclusion criteria (6 listed)
- self-reported physical activity on a regular basis within the last six months (2 times or more per week);
- younger than 50 years of age;
- relapse in the last 30 days;
- no regular access to a television;
- no physician-confirmed diagnosis of multiple sclerosis;
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 |
|---|---|---|
| Home-based, DVD-delivered physical activitySubjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance. Exercises will be progressive over the six-months and will highlight modifications for varying levels. This program will be delivered on 3 DVDs. Participants will be asked to exercise with the DVD at least three times per week. | Behavioural | Experimental: FlexToBa physical activity DVD |
| Behavioral: Usual care/Wait listParticipants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing. | Behavioural | Usual care-Wait list |
Primary outcome
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
Time frame: Baseline and six months
The measurements will include: Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Time frame: Baseline and six-months
Measurements will include: Timed 20-foot walk test -- walk 25 feet as quickly as possible;
Change in assessments of functional fitness assessments in sedentary adults with MS
Time frame: Baseline and six-months
Measurements will include: 6-minute walk test -- walk as much as possible (in terms of distance) for 6 minutes;
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Time frame: Baseline and six-months
Measurements will include: Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength;
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Time frame: Baseline and six-months
Measurements will include: Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility)
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Time frame: Baseline and six-months
Measurements will include: Upper body strength -- bicep curls consisting of lifting a light hand-weight as many times as possible in 30-seconds;
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Time frame: Baseline and six-months
Measurements will include: Balance -- a timed (up to 30-seconds) unassisted one-leg stand test with eyes open on each leg.
Change from baseline to six-months in assessments of reported quality of life in people with MS
Time frame: Baseline and six months
The Leeds Multiple Sclerosis Quality of Life Scale will be used as a disease specific quality of life measure for people with MS.
Change from baseline to six-months in assessments of reported quality of life in people with MS
Time frame: Baseline and six-months
The Satisfaction with Life Scale will be used to assess global life satisfaction and is sensitive enough to detect changes in participants' perceptions over the course of a clinical intervention.
8 secondary outcomes
Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
Time frame: Baseline and six months
Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
Time frame: Baseline and six months
Changes in physical activity relating to specified exercise program in sedentary adults with MS
Time frame: Baseline and six months
Objective changes in physical activity in sedentary adults with MS
Time frame: Baseline and six months
Self-reported changes in physical activity in sedentary adults with MS
Time frame: Baseline and six months
Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
Time frame: Baseline and six-months
Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
Time frame: Baseline and six-months
Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
Time frame: Baseline and six-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 25448627Wojcicki TR, Roberts SA, Learmonth YC, Hubbard EA, Kinnett-Hopkins D, Motl RW, McAuley E. Improving physical functional and quality of life in older adults with multiple sclerosis via a DVD-delivered exercise intervention: a study protocol. BMJ Open. 2014 Dec 1;4(12):e006250. doi: 10.1136/bmjopen-2014-006250.
- Exercise Psychology Lab at University of Illinois at Urbana-ChampaignLink provided by the sponsor.
- 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.
Edward McAuley, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based, DVD-delivered physical activity in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Feb 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis (time frame: Baseline and six months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01993095, which also lists 1 linked publication.
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 23 Feb 2017.