University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801, United States
NCT Number: NCT01993095
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Urbana, Illinois, 61801, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
Time frame: Baseline and six-months
Measurements will include:
Timed 20-foot walk test -- walk 25 feet as quickly as possible;
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;
Time frame: Baseline and six-months
Measurements will include:
Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength;
Time frame: Baseline and six-months
Measurements will include:
Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility)
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;
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.
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.
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.
Time frame: Baseline and six months
The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
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.
Time frame: Baseline and six months
Adherence to exercise program as documented by daily exercise logs.
Time frame: Baseline and six months
Objective assessment of physical activity via accelerometry over seven days time.
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.
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.
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.
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.
University of Illinois at Urbana-Champaign
Other
Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
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