Workout on Wheels Internet Intervention (WOWii)

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: WOWii (Workout on Wheels Internet Intervention)

• Registration Number: NCT03189095
• Lead Sponsor: Baylor Research Institute

Brief 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.

Study Timeline

• Study Start: 2017-06-06
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	WOWii (Workout on Wheels Internet Intervention)	-

Primary Outcome Measures

Name	Time	Method
Change in aerobic exercise (Participant adoption)	Baseline & 16 weeks	minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Aerobic exercise maintenance	16 weeks	minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)

Secondary Outcome Measures

Name	Time	Method
Exercise Self-Efficacy	16 weeks	health promotion scale with exercise subscale Self Rated Abilities for Health Practices Scale (SRAHP)
Change in aerobic fitness	Baseline & 16 weeks	peak V02 using continuous, graded arm crank protocol
Change in perceived exercise barriers	Baseline & 16 weeks	Change in summary score of barriers on The Barriers to Health Activities among Disabled Persons scale (BHADP) from baseline to 16 weeks

Trial Locations

Locations (1)

Baylor Institute for Rehabilitation; 🇺🇸 Dallas, Texas, United States