Workout on Wheels Internet Intervention (WOWii)
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WOWii (Workout on Wheels Internet Intervention)
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injuries focused on measuring exercise, physical activity, SCI, spinal cord injury, online
Eligibility Criteria
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.
Sites / Locations
- Baylor Institute for Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Wait-List Control
Arm Description
Outcomes
Primary Outcome Measures
Change in aerobic exercise (Participant adoption)
minutes per week measured by Polar activity tracker (objective)
Aerobic exercise maintenance
minutes per week measured by Polar activity tracker (objective)
Change in aerobic exercise (Participant adoption)
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Aerobic exercise maintenance
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Secondary Outcome Measures
Change in aerobic fitness
peak V02 using continuous, graded arm crank protocol
Exercise Self-Efficacy
health promotion scale with exercise subscale Self Rated Abilities for Health Practices Scale (SRAHP)
Change in perceived exercise barriers
Change in summary score of barriers on The Barriers to Health Activities among Disabled Persons scale (BHADP) from baseline to 16 weeks
Full Information
NCT ID
NCT03189095
First Posted
June 9, 2017
Last Updated
January 15, 2020
Sponsor
Baylor Research Institute
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
1. Study Identification
Unique Protocol Identification Number
NCT03189095
Brief Title
Workout on Wheels Internet Intervention (WOWii)
Official Title
Project Workout on Wheels Internet Intervention (WOWii): Summative Evaluation With Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
exercise, physical activity, SCI, spinal cord injury, online
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Wait-List Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
WOWii (Workout on Wheels Internet Intervention)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in aerobic exercise (Participant adoption)
Description
minutes per week measured by Polar activity tracker (objective)
Time Frame
16 weeks
Title
Aerobic exercise maintenance
Description
minutes per week measured by Polar activity tracker (objective)
Time Frame
16 weeks
Title
Change in aerobic exercise (Participant adoption)
Description
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Time Frame
Baseline & 16 weeks
Title
Aerobic exercise maintenance
Description
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in aerobic fitness
Description
peak V02 using continuous, graded arm crank protocol
Time Frame
Baseline & 16 weeks
Title
Exercise Self-Efficacy
Description
health promotion scale with exercise subscale Self Rated Abilities for Health Practices Scale (SRAHP)
Time Frame
16 weeks
Title
Change in perceived exercise barriers
Description
Change in summary score of barriers on The Barriers to Health Activities among Disabled Persons scale (BHADP) from baseline to 16 weeks
Time Frame
Baseline & 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Froehlich-Grobe, Ph.D.
Organizational Affiliation
Baylor Institute for Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Institute for Rehabilitation
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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