Spinal Cord InjuriesNCT03189095
Workout on Wheels Internet Intervention (WOWii)
A study testing WOWii (Workout on Wheels Internet Intervention) in people with Spinal Cord Injuries, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- WOWii (Workout on Wheels Internet Intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not receive physician approval to begin an exercise program;
- Have participated in the previous pilot studies; and
- Unable to read the English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Institute for Rehabilitation
Dallas, Texas, 75246
About this study
Official title: Project Workout on Wheels Internet Intervention (WOWii): Summative Evaluation With Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- WOWii (Workout on Wheels Internet Intervention)
- Keywords
- exercise, physical activity, SCI, spinal cord injury, online
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOWii (Workout on Wheels Internet Intervention)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: WOWii (Workout on Wheels Internet Intervention) |
| Wait-List Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aerobic exercise (Participant adoption)
minutes per week measured by Polar activity tracker (objective)
Measured: 16 weeks
Aerobic exercise maintenance
minutes per week measured by Polar activity tracker (objective)
Measured: 16 weeks
Change in aerobic exercise (Participant adoption)
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Measured: Baseline & 16 weeks
Aerobic exercise maintenance
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Measured: 16 weeks
Secondary outcomes (3)
Change in aerobic fitness
peak V02 using continuous, graded arm crank protocol
Measured: Baseline & 16 weeks
Exercise Self-Efficacy
health promotion scale with exercise subscale Self Rated Abilities for Health Practices Scale (SRAHP)
Measured: 16 weeks
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
Measured: Baseline & 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start6 Jun 2017
- Primary completion1 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Katherine Froehlich-Grobe, Ph.D., Principal investigator, Baylor Institute for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189095
- Sponsor's protocol ID
- 016-093
- Status last verified
- Jan 2020
- First submitted
- 9 Jun 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Workout on Wheels Internet Intervention (WOWii): Summative Evaluation With Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03189095
- Acronym / sponsor ID
- 016-093
- Conditions
- Spinal Cord Injuries
- Keywords
- exercise, physical activity, SCI, spinal cord injury, online
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: WOWii (Workout on Wheels Internet Intervention) |
| Wait-List Control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Not receive physician approval to begin an exercise program;
- Have participated in the previous pilot studies; and
- Unable to read the English language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WOWii (Workout on Wheels Internet Intervention)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. | Behavioural | Intervention |
Primary outcome
Change in aerobic exercise (Participant adoption)
Time frame: 16 weeks
minutes per week measured by Polar activity tracker (objective)
Aerobic exercise maintenance
Time frame: 16 weeks
minutes per week measured by Polar activity tracker (objective)
Change in aerobic exercise (Participant adoption)
Time frame: Baseline & 16 weeks
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
Aerobic exercise maintenance
Time frame: 16 weeks
minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
3 secondary outcomes
Change in aerobic fitness
Time frame: Baseline & 16 weeks
Exercise Self-Efficacy
Time frame: 16 weeks
Change in perceived exercise barriers
Time frame: Baseline & 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Froehlich-Grobe, Ph.D. principal investigator
Baylor Institute for Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WOWii (Workout on Wheels Internet Intervention) in people with Spinal Cord Injuries, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aerobic exercise (Participant adoption) (time frame: 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.