跳至主要内容
临床试验/NCT05353842
NCT05353842进行中(未招募)不适用

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

Craig Hospital4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
4
主要终点
Enrollment of Participants in WOWii Program (feasibility)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Enrollment of Participants in WOWii Program (feasibility)

时间窗: One time at end of study recruitment

Total number of participants enrolled at each site

Change in number of minutes spent in aerobic exercise (effectiveness)

时间窗: Baseline, end of intervention (Week 16), end of follow up (Week 24)

Objective measure of change in activity level

Percentage of behavior skills covered by peer facilitators during WOWii Program (fidelity)

时间窗: One time at end of 16 week intervention

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

Change in score on International Physical Activity Questionnaire Scores (effectiveness)

时间窗: 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.

Retention of Participants Enrolled in WOWii Program (feasibility)

时间窗: One time at end of 16 week intervention

Total number of WOWii sessions attended

Engagement of Participants Enrolled in WOWii Program (feasibilty)

时间窗: One time at end of 16 week intervention

Total number of WOWii online activities completed

% of WOWii sessions in which peer facilitators generate group-based conversation (fidelity)

时间窗: One time at end of 16 week intervention

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Froehlich-Grobe

Research Scientist

Craig Hospital

研究点 (4)

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