Project Workout on Wheels Internet Intervention (WOWii): Summative Evaluation With Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change in aerobic exercise (Participant adoption)
研究概览
简要总结
Project WOWii examines how useful and effective an online format is for helping people with SCI get more exercise over 4 months. Study participants will meet over Skype weekly for 16 weeks and work through weekly online modules to start and stick with an accessible and individualized exercise program. Participants will be compensated for their time to attend fitness testing and complete surveys before and just after the 16-week program.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Not receive physician approval to begin an exercise program;
- •Have participated in the previous pilot studies; and
- •Unable to read the English language.
研究组 & 干预措施
Intervention
干预措施: WOWii (Workout on Wheels Internet Intervention) (Behavioral)
Wait-List Control
结局指标
主要结局
Change in aerobic exercise (Participant adoption)
时间窗: Baseline & 16 weeks
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Aerobic exercise maintenance
时间窗: 16 weeks
minutes per week measured by Polar activity tracker (objective)
Change in aerobic exercise (Participant adoption)
时间窗: 16 weeks
minutes per week measured by Polar activity tracker (objective)
次要结局
- Exercise Self-Efficacy(16 weeks)
- Change in aerobic fitness(Baseline & 16 weeks)
- Change in perceived exercise barriers(Baseline & 16 weeks)
