Workout on Wheels Internet Intervention (WOWii)
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): WOWii (Workout on Wheels Internet Intervention)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators opted to use a wait-list control group to serve as an untreated comparison for the experimental group. From the investigators' perspective, people calling about an exercise trial want to receive an intervention, and thus, they believe it would be unethical to deny access to the intervention. Control group participants will be asked to continue their current activity level over the 16 weeks and following their posttest, they will be invited to participate in the WOWii program in full. The investigators will examine whether differential dropouts occur between those assigned to the experimental and wait-list control groups. The investigators previous exercise study conducted among women with mobility impairment indicated slightly lower attrition in the wait list control group, with no significant differences between those who withdrew and those who remained in the study by six months.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise; physical activity; SCI; spinal cord injury; online