Workout on Wheels Internet Intervention (WOWii)
Project Workout on Wheels Internet Intervention (WOWii): Summative Evaluation With Randomized Clinical Trial
研究概览
详细说明
This study will gather empirical evidence of the effectiveness of WOWii intervention in promoting changes in exercise behavior, fitness, and perceptions of exercise over the 16 week intervention as well as 2 months later for individuals living with SCI. The study staff will assess effectiveness by measuring participants (a) time spent each week doing aerobic exercise by self-report and objective monitoring, (b) aerobic capacity to assess fitness changes, and (c) self-reported perceptions of exercise barriers and self-efficacy at baseline, 4 months, and 6 months.
Participants will be randomly assigned to an experimental (WOWii) or a wait-list control group in one of four cohorts over a two-year period. This was an effective strategy in our previous trial in helping us achieve the full sample size. We will use a blocked randomization procedure to assure equal distribution of those with paraplegia and tetraplegia. Four cohorts will be enrolled over two years, with each having up to 36 people. This allows for up to 18 participants in the experimental and control groups, which permits us to offer two different time options for participants to attend the weekly meetings, as our video conferencing software allows up to 10 people to participate in the group video chat. Each cohort will be divided into two groups of 18 study participants as experimental and wait-list control groups. The experimental group will be divided into two groups of nine participants. Each cohort will begin the intervention at the same time and attend weekly calls together. All participants will undergo a pre-screen assessment which includes eligibility assessment. Participants will undergo 2 in-person fitness testing assessments at baseline at the end of the 16 week internet intervention with online meetings, before or during which they will complete an online survey and follow. A third follow up assessment will be conducted as an online survey at 6 months, which is 2 months after the intervention is complete, and an exit survey will be conducted individually over the phone after within one week of completing the final online survey. The wait-list control group will be offered the intervention at the end of the 6 month period. Due to low enrollment numbers, we will likely add a 5th cohort for enrollment.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国、75246
- Baylor Institute for Rehabilitation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Between the ages of 18 - 70 years old;
- Have SCI > 6 months with the ability to use arms enough for arm-based exercise and requires wheelchair use;
- Have access to a computer with internet access or if they do not have computer/internet access, have experience using a computer and going online;
- Obtain physician signed approval to participate in the exercise study; and
- Not be currently physically active, based on responses to the 7-item Behavioral Risk Factor Surveillance physical activity survey.
Exclusion Criteria:
- Not receive physician approval to begin an exercise program;
- Have participated in the previous pilot studies; and
- Unable to read the English language.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 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 |
|---|---|
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实验性的:干涉
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Participants will self-monitor their exercise on the WOWii website, which has a page to record the type, duration, and intensity of daily exercise bouts. Two devices will track participants' exercise, a Polar heart rate monitor (RS300X, Polar®), which will provide data on the day, duration, and intensity (average and maximum) of aerobic activity and an ActiGraph accelerometer (model GT3X), which detects movement in three planes to indicate frequency and intensity of movement throughout the day. Experimental participants will be provided a Polar heart rate monitor to wear during each exercise bout for the entire length of the 6-month study, and exercise data will be collected weekly. Physiological outcomes on fitness will be assessed by measuring weight and aerobic capacity in a Cardiopulmonary Lab by a doctoral-trained physical therapist. Participants will complete surveys to report on their exercise self-efficacy and perceived barriers. |
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无干预:Wait-List Control
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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 |
|---|---|---|
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Change in aerobic exercise (Participant adoption)
大体时间:16 weeks
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minutes per week measured by Polar activity tracker (objective)
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16 weeks
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Aerobic exercise maintenance
大体时间:16 weeks
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minutes per week measured by Polar activity tracker (objective)
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16 weeks
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Change in aerobic exercise (Participant adoption)
大体时间:Baseline & 16 weeks
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minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
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Baseline & 16 weeks
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Aerobic exercise maintenance
大体时间:16 weeks
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minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
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16 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in aerobic fitness
大体时间:Baseline & 16 weeks
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peak V02 using continuous, graded arm crank protocol
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Baseline & 16 weeks
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Exercise Self-Efficacy
大体时间:16 weeks
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health promotion scale with exercise subscale Self Rated Abilities for Health Practices Scale (SRAHP)
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16 weeks
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Change in perceived exercise barriers
大体时间:Baseline & 16 weeks
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Change in summary score of barriers on The Barriers to Health Activities among Disabled Persons scale (BHADP) from baseline to 16 weeks
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Baseline & 16 weeks
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合作者和调查者
调查人员
- 首席研究员:Katherine Froehlich-Grobe, Ph.D.、Baylor Institute for Rehabilitation
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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