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

NCT05353842 | Active Not Recruiting

• 1 other identifier: 901FRE0046-01-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (1)

WOWii Intervention

EXPERIMENTAL

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

Interventions

WOWii Program BEHAVIORAL

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.

WOWii Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Craig Hospital: lead
• Kessler Institute for Rehabilitation: collaborator
• Shepherd Center, Atlanta GA: collaborator

Study Sites (2)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: April 29, 2022
• Study Start: January 2, 2022
• Primary Completion: September 29, 2024
• Study Completion: September 30, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)