A Sedentary Behaviour Reduction Intervention for People With COPD
2020年6月2日 更新者：Roger Goldstein、West Park Healthcare Centre
Get Up For Your Health: A Behaviour Change Intervention to Reduce Sedentary Behaviour for People With COPD
Chronic obstructive pulmonary disease (COPD) is a major cause of disability.
Individuals with COPD are more likely to spend prolonged periods of time in sedentary behaviour (SB) and less in light physical activity compared to their healthy peers.
SB is associated with exercise intolerance, reduced motivation to exercise, lower self-efficacy and more frequent acute exacerbations among people with COPD.
To date, there is very limited information regarding behavioural approaches to reduce SB in people with COPD.
The aim of this study is to examine the feasibility of a new 4-week theory-informed behaviour change intervention to reduce SB in individuals with COPD.
研究概览
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Ontario
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Toronto、Ontario、加拿大、M6M 2J5
- West Park Healthcare Centre
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- A diagnosis of COPD confirmed by spirometry Forced expired volume to forced vital capacity ration (FEV1/FVC) less than 0.7
- An ability to ambulate.
- An ability to provide informed consent.
Exclusion Criteria:
- Presence of co-existing conditions that may prevent participation in the intervention.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention
This was a single arm study with all participants receiving the same intervention.
Participants will receive a 4-week behaviour change intervention underpinned by the Theoretical Domains Framework (TDF) that aims to reduce sedentary behaviour.
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The intervention is a 4-week behaviour change intervention underpinned by the Theoretical Domains Framework (TDF) that aims to reduce sedentary behaviour. The intervention consists of one individualized face-to-face session and 3 subsequent weekly points of contact (face-to-face meetings or phone calls). Behaviour change techniques will be provided including education, verbal persuasion, environmental restructuring and goal-setting. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Enrollment rate
大体时间：4 weeks
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Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)
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4 weeks
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Completion rate
大体时间：4 weeks
|
Percentage of those enrolled who completed the program
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4 weeks
|
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Participants satisfaction
大体时间：4 weeks
|
Participant satisfaction will be assessed on a percentage scale of 0 to 100, with 100 being the best possible score.
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4 weeks
|
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Adherence to wearing the activity monitor
大体时间：4 weeks
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Percentage of those who were able to provide data for at least 8 hours per day of wearing time during waking hours and for at least 4 days/week for the entire duration of the study
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in sedentary time
大体时间：Baseline - week 4 (post-intervention)
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To assess the change in sedentary time as measured using an accelerometer from baseline to post-intervention.
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Baseline - week 4 (post-intervention)
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Change in number of sit-to-stand transitions
大体时间：Baseline - week 4 (post-intervention)
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To assess the change in the number of sit-to-stand transitions as measured using an accelerometer from baseline to post-intervention.
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Baseline - week 4 (post-intervention)
|
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Change in daily number of steps
大体时间：Baseline - week 4 (post-intervention)
|
To assess the change in the number of steps as measured using an accelerometer from baseline to post-intervention.
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Baseline - week 4 (post-intervention)
|
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Change in self-efficacy
大体时间：Baseline - week 4 (post-intervention)
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To assess the change in self-efficacy to sit less using a scale adapted from the Multidimensional Self-Efficacy Scale over time from baseline to post-intervention.
The scale consists of 9 items that measures 3 components of self-efficacy (task, coping and scheduling) with each item is measured on a scale of 0 (no confidence at all) up to 100 (complete confidence).
The total score is the average of the scores of the 9 items.
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Baseline - week 4 (post-intervention)
|
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Change in outcome expectations
大体时间：Baseline - week 4 (post-intervention)
|
To assess the change in the outcome expectations using a 15-item scale adapted from the Multidimensional Outcome Expectations for Exercise Scale over time from baseline to post-intervention.
The questionnaire is a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), that assesses physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items) with the higher the scores the more positive the outcome expectations are.
The total score is the sum of the score of the 15 items.
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Baseline - week 4 (post-intervention)
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Change in knowledge of sedentary behaviour
大体时间：Baseline - week 4 (post-intervention)
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To assess the change in sedentary behaviour using an 8-item True or False questionnaire with higher scores indicating better knowledge of sedentary behaviour
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Baseline - week 4 (post-intervention)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Dina Brooks, PhD、McMaster University
- 首席研究员：Roger Goldstein, MD、West Park Healthcare Centre
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年6月19日
初级完成 (实际的)
2019年12月18日
研究完成 (实际的)
2019年12月18日
研究注册日期
首次提交
2019年6月30日
首先提交符合 QC 标准的
2019年6月30日
首次发布 (实际的)
2019年7月2日
研究记录更新
最后更新发布 (实际的)
2020年6月4日
上次提交的符合 QC 标准的更新
2020年6月2日
最后验证
2020年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
慢性阻塞性肺病的临床试验
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Bangabandhu Sheikh Mujib Medical University, Dhaka...完全的
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University College, LondonUniversity of Cambridge; National Institute for Health Research, United Kingdom; Royal Free Hampstead...未知
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Virginia Commonwealth UniversityFisher and Paykel Healthcare完全的
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AstraZeneca完全的
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Chiesi Farmaceutici S.p.A.完全的中度至重度慢性阻塞性肺疾病 (COPD)保加利亚, 德国, 匈牙利, 波兰, 俄罗斯联邦, 英国
Get Up For Your Health的临床试验
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Universidad del DesarrolloSuperintendencia de Seguridad Social, Chile招聘中
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Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)主动，不招人
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Florida State UniversityUniversity of North Carolina, Chapel Hill; University of Georgia邀请报名
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Ohio State UniversityUniversity of Chicago; National Institutes of Health (NIH); Resilient Games Studio尚未招聘青春期行为