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

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WOWii Program
Sponsored by
Craig Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shepherd CenterRecruiting
  • Kessler Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WOWii Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Enrollment of Participants in WOWii Program (feasibility)
Total number of participants enrolled at each site
Retention of Participants Enrolled in WOWii Program (feasibility)
Total number of WOWii sessions attended
Engagement of Participants Enrolled in WOWii Program (feasibilty)
Total number of WOWii online activities completed
Percentage of behavior skills covered by peer facilitators during WOWii Program (fidelity)
Percentage of items on fidelity check list that are marked as completed
% 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
Change in number of minutes spent in aerobic exercise (effectiveness)
Objective measure of change in activity level
Change in score on International Physical Activity Questionnaire Scores (effectiveness)
8-item survey asking days/week and minutes/day spent in various physical activities.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2022
Last Updated
August 28, 2023
Sponsor
Craig Hospital
Collaborators
Kessler Institute for Rehabilitation, Shepherd Center, Atlanta GA
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1. Study Identification

Unique Protocol Identification Number
NCT05353842
Brief Title
Scale Up of Project Workout on Wheels Internet Intervention (WOWii)
Acronym
WOWii
Official Title
Scale Up Trial of Project WOWii to Increase Exercise Among People With Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital
Collaborators
Kessler Institute for Rehabilitation, Shepherd Center, Atlanta GA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Morey, MA
Phone
303-789-8621
Email
cmorey@craighospital.org
Facility Information:
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Lopez, MPH
Phone
404-350-7656
Email
amber.lopez@shepherd.org
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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