Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Home-based, DVD-delivered physical activity (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.
干预措施: Behavioral: Usual care/Wait list (Behavioral)
结局指标
主要结局
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
时间窗: Baseline and six-months
Measurements will include: Timed 20-foot walk test -- walk 25 feet as quickly as possible;
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
时间窗: Baseline and six-months
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 Multiple Sclerosis
时间窗: Baseline and six months
The measurements will include: Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance
Change in assessments of functional fitness assessments in sedentary adults with MS
时间窗: Baseline and six-months
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 reported quality of life in people with MS
时间窗: 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.
Change from baseline to six-months in assessments of reported quality of life in people with MS
时间窗: 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.
次要结局
- Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS(Baseline and six-months)
- 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)
- Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS(Baseline and six-months)
- Self-reported changes in physical activity in sedentary adults with MS(Baseline and six months)
- Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS(Baseline and six-months)
研究者
Edward McAuley
Professor, Kinesiology and Community Health
University of Illinois at Urbana-Champaign