search
Back to results

FlexToBa for People With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based, DVD-delivered physical activity
Behavioral: Usual care/Wait list
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Quality of Life, Functional Fitness

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: FlexToBa physical activity DVD

Usual care-Wait list

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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;
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;
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;
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)
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;
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.
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.
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.

Secondary Outcome Measures

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.
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.
Changes in physical activity relating to specified exercise program in sedentary adults with MS
Adherence to exercise program as documented by daily exercise logs.
Objective changes in physical activity in sedentary adults with MS
Objective assessment of physical activity via accelerometry over seven days time.
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.
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.
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.
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.

Full Information

First Posted
October 18, 2013
Last Updated
February 21, 2017
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Multiple Sclerosis Society
search

1. Study Identification

Unique Protocol Identification Number
NCT01993095
Brief Title
FlexToBa for People With Multiple Sclerosis
Official Title
Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Quality of Life, Functional Fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: FlexToBa physical activity DVD
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care-Wait list
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based, DVD-delivered physical activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Usual care/Wait list
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
Description
The measurements will include: Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance
Time Frame
Baseline and six months
Title
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Description
Measurements will include: Timed 20-foot walk test -- walk 25 feet as quickly as possible;
Time Frame
Baseline and six-months
Title
Change in assessments of functional fitness assessments in sedentary adults with MS
Description
Measurements will include: 6-minute walk test -- walk as much as possible (in terms of distance) for 6 minutes;
Time Frame
Baseline and six-months
Title
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Description
Measurements will include: Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength;
Time Frame
Baseline and six-months
Title
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Description
Measurements will include: Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility)
Time Frame
Baseline and six-months
Title
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Description
Measurements will include: Upper body strength -- bicep curls consisting of lifting a light hand-weight as many times as possible in 30-seconds;
Time Frame
Baseline and six-months
Title
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Description
Measurements will include: Balance -- a timed (up to 30-seconds) unassisted one-leg stand test with eyes open on each leg.
Time Frame
Baseline and six-months
Title
Change from baseline to six-months in assessments of reported quality of life in people with MS
Description
The Leeds Multiple Sclerosis Quality of Life Scale will be used as a disease specific quality of life measure for people with MS.
Time Frame
Baseline and six months
Title
Change from baseline to six-months in assessments of reported quality of life in people with MS
Description
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.
Time Frame
Baseline and six-months
Secondary Outcome Measure Information:
Title
Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
Description
The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
Time Frame
Baseline and six months
Title
Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
Description
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.
Time Frame
Baseline and six months
Title
Changes in physical activity relating to specified exercise program in sedentary adults with MS
Description
Adherence to exercise program as documented by daily exercise logs.
Time Frame
Baseline and six months
Title
Objective changes in physical activity in sedentary adults with MS
Description
Objective assessment of physical activity via accelerometry over seven days time.
Time Frame
Baseline and six months
Title
Self-reported changes in physical activity in sedentary adults with MS
Description
Subjective assessment of physical activity via the Godin Leisure Time Exercise Questionnaire, which assesses frequency of involvement in strenuous, moderate and light activities.
Time Frame
Baseline and six months
Title
Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
Description
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.
Time Frame
Baseline and six-months
Title
Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
Description
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.
Time Frame
Baseline and six-months
Title
Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
Description
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.
Time Frame
Baseline and six-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward McAuley, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25448627
Citation
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.
Results Reference
derived
Links:
URL
http://www.epl.illinois.edu
Description
Exercise Psychology Lab at University of Illinois at Urbana-Champaign

Learn more about this trial

FlexToBa for People With Multiple Sclerosis

We'll reach out to this number within 24 hrs