FlexToBa for People With Multiple Sclerosis
2017年2月21日 更新者：Edward McAuley、University of Illinois at Urbana-Champaign
Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Illinois
-
Urbana、Illinois、美国、61801
- University of Illinois at Urbana-Champaign
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
|
|
有源比较器：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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
大体时间：Baseline and six months
|
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
大体时间：Baseline and six-months
|
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
大体时间：Baseline and six-months
|
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
大体时间：Baseline and six-months
|
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
大体时间：Baseline and six-months
|
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
大体时间：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; |
Baseline and six-months
|
|
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
大体时间：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. |
Baseline and six-months
|
|
Change from baseline to six-months in assessments of reported quality of life in people with MS
大体时间：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.
|
Baseline and six months
|
|
Change from baseline to six-months in assessments of reported quality of life in people with MS
大体时间：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.
|
Baseline and six-months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
大体时间：Baseline and six months
|
The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
|
Baseline and six months
|
|
Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
大体时间：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.
|
Baseline and six months
|
|
Changes in physical activity relating to specified exercise program in sedentary adults with MS
大体时间：Baseline and six months
|
Adherence to exercise program as documented by daily exercise logs.
|
Baseline and six months
|
|
Objective changes in physical activity in sedentary adults with MS
大体时间：Baseline and six months
|
Objective assessment of physical activity via accelerometry over seven days time.
|
Baseline and six months
|
|
Self-reported changes in physical activity in sedentary adults with MS
大体时间：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.
|
Baseline and six months
|
|
Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
大体时间：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.
|
Baseline and six-months
|
|
Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
大体时间：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.
|
Baseline and six-months
|
|
Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
大体时间：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.
|
Baseline and six-months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Edward McAuley, PhD、University of Illinois at Urbana-Champaign
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年10月1日
初级完成 (实际的)
2014年9月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2013年10月18日
首先提交符合 QC 标准的
2013年11月20日
首次发布 (估计)
2013年11月25日
研究记录更新
最后更新发布 (实际的)
2017年2月23日
上次提交的符合 QC 标准的更新
2017年2月21日
最后验证
2017年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.