FlexToBa for People With Multiple Sclerosis

NCT ID: NCT01993095

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-09-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Home-based, DVD-delivered physical activity

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Behavioral: Usual care/Wait list

Intervention Type: 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.

Interventions

Home-based, DVD-delivered physical activity

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

Behavioral: 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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Edward McAuley

Professor, Kinesiology and Community Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward McAuley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25448627 (View on PubMed)

Related Links

http://www.epl.illinois.edu

Exercise Psychology Lab at University of Illinois at Urbana-Champaign

Other Identifiers

IL-0009

Identifier Type: -

Identifier Source: org_study_id