- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993095
FlexToBa for People With Multiple Sclerosis
Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois at Urbana-Champaign
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: FlexToBa physical activity DVD
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.
|
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.
|
Active Comparator: Usual care-Wait list
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Baseline and six months
|
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; |
Baseline and six-months
|
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; |
Baseline and six-months
|
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; |
Baseline and six-months
|
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) |
Baseline and six-months
|
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; |
Baseline and six-months
|
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. |
Baseline and six-months
|
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.
|
Baseline and six months
|
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.
|
Baseline and six-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
Time Frame: Baseline and six months
|
The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
|
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
|
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.
|
Baseline and six months
|
Changes in physical activity relating to specified exercise program in sedentary adults with MS
Time Frame: Baseline and six months
|
Adherence to exercise program as documented by daily exercise logs.
|
Baseline and six months
|
Objective changes in physical activity in sedentary adults with MS
Time Frame: Baseline and six months
|
Objective assessment of physical activity via accelerometry over seven days time.
|
Baseline and six months
|
Self-reported changes in physical activity in sedentary adults with MS
Time Frame: Baseline and six months
|
Subjective assessment of physical activity via the Godin Leisure Time Exercise Questionnaire, which assesses frequency of involvement in strenuous, moderate and light activities.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Baseline and six-months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IL-0009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Home-based, DVD-delivered physical activity
-
University of Illinois at Urbana-ChampaignNational Institute on Aging (NIA)Completed
-
Scientific Institute San RaffaeleCompleted
-
Scientific Institute San RaffaeleIstituto Ortopedico GaleazziRecruiting
-
Rutgers, The State University of New JerseyTerminatedBreast Cancer | Resistance TrainingUnited States
-
University Hospital of FerraraUniversità degli Studi di FerraraRecruitingChronic Kidney Disease Stage 5 on DialysisItaly
-
Centre Jean PerrinRecruitingHER2 Positive Breast CancerFrance
-
AHS Cancer Control AlbertaCross Cancer InstituteCompleted
-
University Hospital, GrenobleAGIR à DomNot yet recruitingAnorexia NervosaFrance
-
Aveiro UniversityFundação para a Ciência e a Tecnologia; Centro Hospitalar do Baixo VougaCompletedInterstitial Lung Diseases (ILD)Portugal
-
Children's Hospital of Eastern OntarioHeart and Stroke Foundation of CanadaRecruitingCongenital Heart DefectCanada