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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: WOWii Program

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WOWii Intervention; Workout on Wheels Internet Intervention (WOWii) program 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment of Participants in WOWii Program (feasibility)	Total number of participants enrolled at each site	One time at end of study recruitment
Retention of Participants Enrolled in WOWii Program (feasibility)	Total number of WOWii sessions attended	One time at end of 16 week intervention
Engagement of Participants Enrolled in WOWii Program (feasibilty)	Total number of WOWii online activities completed	One time at end of 16 week intervention
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
% 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
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)
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)

Collaborators and Investigators

• Sponsor: Craig Hospital
• Collaborators: Kessler Institute for Rehabilitation; Shepherd Center, Atlanta GA

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Estimated): September 29, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 901FRE0046-01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No