Scale Up of Project Workout on Wheels Internet Intervention (WOWii)

Spinal Cord Injuries Clinical Trial

— WOWii  

Official title:

Scale Up Trial of Project WOWii to Increase Exercise Among People With Spinal Cord Injury (SCI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05353842
• Other study ID #: 901FRE0046-01-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed is to test the feasibility, fidelity, and effectiveness of scaling up an evidence- and theory-based virtually delivered physical activity intervention (WOWii) for individuals living with chronic SCI for delivery through other rehabilitation settings. The study outcomes address (1) feasibility based on participant enrollment, retention, and program engagement; (2) fidelity of intervention delivery; and (3) program effectiveness based on subjective and objective exercise data, and participant exercise perceptions regarding self-efficacy and barriers.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 30, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• more than 12 months post SCI

• requires use of wheelchair due to SCI

• receive signed approval from medical provider to initiate moderate-intensity exercise program

• have internet access via computer, tablet, or smartphone

• provide informed consent

Exclusion Criteria:

• already engaged in engaged in sufficient physical activity to meet CDCP guidelines

• cognitive of language impairments that would affect ability to participate

• presence of medical issue for which exercise is contraindicated

• pregnancy

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Behavioral:
• WOWii Program
Workout on Wheels Internet Internvention (WOWii) which includes: 1) WOWii website to guide participants in an exercise program, 2) home exercise starter program; 3) weekly support from a peer facilitator via online (video) meetings.

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Craig Hospital	Kessler Institute for Rehabilitation, Shepherd Center, Atlanta GA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment of Participants in WOWii Program (feasibility)	Total number of participants enrolled at each site	One time at end of study recruitment
Primary	Retention of Participants Enrolled in WOWii Program (feasibility)	Total number of WOWii sessions attended	One time at end of 16 week intervention
Primary	Engagement of Participants Enrolled in WOWii Program (feasibilty)	Total number of WOWii online activities completed	One time at end of 16 week intervention
Primary	Percentage of behavior skills covered by peer facilitators during WOWii Program (fidelity)	Percentage of items on fidelity check list that are marked as completed	One time at end of 16 week intervention
Primary	% of WOWii sessions in which peer facilitators generate group-based conversation (fidelity)	% of sessions on fidelity check list that are marked as having grop-based conversation	One time at end of 16 week intervention
Primary	Change in number of minutes spent in aerobic exercise (effectiveness)	Objective measure of change in activity level	Baseline, end of intervention (Week 16), end of follow up (Week 24)
Primary	Change in score on International Physical Activity Questionnaire Scores (effectiveness)	8-item survey asking days/week and minutes/day spent in various physical activities.	Baseline, end of intervention (Week 16), end of follow up (Week 24)