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

Sponsor
Craig Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05353842
Collaborator
Kessler Institute for Rehabilitation (Industry), Shepherd Center, Atlanta GA (Other)
200
2
1
20.9
100
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: WOWii Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Scale Up Trial of Project WOWii to Increase Exercise Among People With Spinal Cord Injury (SCI)
Actual Study Start Date :
Jan 2, 2022
Anticipated Primary Completion Date :
Sep 29, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Enrollment of Participants in WOWii Program (feasibility) [One time at end of study recruitment]

    Total number of participants enrolled at each site

  2. Retention of Participants Enrolled in WOWii Program (feasibility) [One time at end of 16 week intervention]

    Total number of WOWii sessions attended

  3. Engagement of Participants Enrolled in WOWii Program (feasibilty) [One time at end of 16 week intervention]

    Total number of WOWii online activities completed

  4. Percentage of behavior skills covered by peer facilitators during WOWii Program (fidelity) [One time at end of 16 week intervention]

    Percentage of items on fidelity check list that are marked as completed

  5. % of WOWii sessions in which peer facilitators generate group-based conversation (fidelity) [One time at end of 16 week intervention]

    % of sessions on fidelity check list that are marked as having grop-based conversation

  6. Change in number of minutes spent in aerobic exercise (effectiveness) [Baseline, end of intervention (Week 16), end of follow up (Week 24)]

    Objective measure of change in activity level

  7. Change in score on International Physical Activity Questionnaire Scores (effectiveness) [Baseline, end of intervention (Week 16), end of follow up (Week 24)]

    8-item survey asking days/week and minutes/day spent in various physical activities.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shepherd Center Atlanta Georgia United States 30309
2 Kessler Foundation West Orange New Jersey United States 07052

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katherine Froehlich-Grobe, Research Scientist, Craig Hospital
ClinicalTrials.gov Identifier:
NCT05353842
Other Study ID Numbers:
  • 901FRE0046-01-01
First Posted:
Apr 29, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022