Clinical trial NCT01993095: FlexToBa for People With Multiple Sclerosis
Official title: Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Quality of Life
Functional Fitness
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2013-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
timeFrame: Baseline and six months
measure: Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
timeFrame: Baseline and six-months
measure: Change in assessments of functional fitness assessments in sedentary adults with MS
timeFrame: Baseline and six-months
measure: Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
timeFrame: Baseline and six-months
measure: Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
timeFrame: Baseline and six-months
measure: Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
timeFrame: Baseline and six-months
measure: Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
timeFrame: Baseline and six-months
measure: Change from baseline to six-months in assessments of reported quality of life in people with MS
timeFrame: Baseline and six months
measure: Change from baseline to six-months in assessments of reported quality of life in people with MS
timeFrame: Baseline and six-months
Secondary outcomes:
measure: Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
timeFrame: Baseline and six months
measure: Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
timeFrame: Baseline and six months
measure: Changes in physical activity relating to specified exercise program in sedentary adults with MS
timeFrame: Baseline and six months
measure: Objective changes in physical activity in sedentary adults with MS
timeFrame: Baseline and six months
measure: Self-reported changes in physical activity in sedentary adults with MS
timeFrame: Baseline and six months
measure: Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
timeFrame: Baseline and six-months
measure: Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
timeFrame: Baseline and six-months
measure: Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
timeFrame: Baseline and six-months
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Edward McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.