FlexToBa for People With Multiple Sclerosis

NCT01993095 | Completed

• 1 other identifier: IL-0009
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Quality of Life; Functional Fitness

Outcome Measures

Primary Outcomes (9)

• 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

  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;

  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;

  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;

  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)

  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;

  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.

  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.

  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.

  Baseline and six-months

Secondary Outcomes (8)

• Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS

  Baseline and six months

• Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS

  Baseline and six months

• Changes in physical activity relating to specified exercise program in sedentary adults with MS

  Baseline and six months

• Objective changes in physical activity in sedentary adults with MS

  Baseline and six months

• Self-reported changes in physical activity in sedentary adults with MS

  Baseline and six months

Study Arms (2)

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.

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.

Behavioral: Behavioral: Usual care/Wait list

Interventions

Home-based, DVD-delivered physical activity BEHAVIORAL

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.

Experimental: FlexToBa physical activity DVD

Behavioral: Usual care/Wait list BEHAVIORAL

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.

Usual care-Wait list

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

• 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.

  PMID: 25448627 DERIVED

Related Links

• Exercise Psychology Lab at University of Illinois at Urbana-Champaign

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Edward McAuley, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Kinesiology and Community Health

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)