The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
2022年2月7日 更新者：Shane Norman Sweet、McGill University
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD: a Pilot Randomized Controlled Trial
This study aims to evaluate the effects of an online exercise and peer support intervention for people living with COPD.
In the framework of a randomized control trial, 24 adults with COPD will be recruited to participate in the study and will be randomly assigned to either the control or intervention group.
The control group will participate in an 8-week virtual program based on the exercise component of a standard home-based pulmonary rehabilitation program (one online consultation and 7 phone calls with a kinesiologist).
The intervention group will participate in a twice a week online intervention that includes an exercise component based on individuals' activities of daily living and a peer support component where individuals will be taught and encouraged to discuss behaviour change techniques that have been shown to help support increased participation in physical activity and/or exercise.
The goal of this study is to determine the efficacy of the novel online exercise intervention and whether the benefits are above other intervention options.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
22
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
-
-
Quebec
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Montreal、Quebec、加拿大、H3A 0G4
- McGill University
-
-
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
18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:
- Individuals must be at least 18 years of age, have no diagnosed cognitive impairment, have a COPD diagnosis, be medically able to participate in exercise (confirmed by healthcare professional in the past 2 years), have access to a computer with a camera and internet, speak English or French, and have the intention to become physically active in the next 2 months or have been minimally active (<150 minutes per week) in the past 2 months
Exclusion Criteria:
- less than 18 years of age, diagnosed with a cognitive impairment, not diagnosed with COPD by a medical professional, unable to participate in exercise or unconfirmed in the past 2 years from a medical professional, no access to a computer and internet.
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention Group
Those randomized to the intervention group will be asked to attend 16 online sessions (2 session/week).
Each session will last one hour (total time: 16 hours.
The exercise portion will be approximately 30 minutes of each session and led by a certified kinesiologist.
These exercises are based on activities related to your daily life.
As well, they will take part in peer support sessions.
The peer support session will be approximately 30 minutes and be moderated by a behaviour change specialist who will also provide strategies to be active.
In this peer support group, particpants will share and learn from other individuals living with COPD to help you stay active during and after the intervention.
The online sessions will be video recorded to make sure that the program is delivered as designed.
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An 8 week two-arm pilot randomized control trial aimed to evaluate the effects of an online exercise and peer support intervention for people living with COPD.
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有源比较器：Control Group
Those randomized to the control group will be asked to participate in an 8-week exercise program based on the exercise component of a standard home-based pulmonary rehabilitation program.
During week 1 of the program, participants will receive a videocall via Microsoft Teams from the certified kinesiologist who will prescribe an exercise program, supervise the first exercise session, and provide a copy of Living Well with COPD, a list of strength exercises, and a home exercise diary.
In weeks 2-8, participant exercises will be performed offline, on their own.
Participants will be encouraged to engage in two or more exercise sessions per week, targeting both aerobic capacity and muscular strength, and document their exercise using a home diary.
They will also receive a phone call once a week from the certified kinesiologist to discuss their exercise progress.
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An 8 week two-arm pilot randomized control trial aimed to evaluate the effects of an online exercise and peer support intervention for people living with COPD.
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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 |
|---|---|---|
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Performance in activities of daily and social living
大体时间：Baseline, 8 and 12 weeks
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Participant goal participation will be measured by improvement in initial goals set at the beginning of the study using the Canadian Occupation Performance Measures (COPM).
Success will be determined by calculating individuals change score on their satisfaction with their performance in their target areas post-intervention.
A change score of 2 on an item is said to represent significant change (Law et al., 2000).
A change score of at least 2 on 50% of items (dependent on personal goals) for 70% of participants will be the indicator of success.
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Baseline, 8 and 12 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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Timed "Up & Go" test
大体时间：Baseline, 8 and 12 weeks
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This test measures the time it takes an individual to stand from a standard chair (approximately 46cm), walk 3 metres, walk back, and return to sit on the chair (Podsiadlo & Richardson, 1991).
The participant is timed from when the leave the seat to when they are seated again.
A time of >30 seconds is the cut-off for safe unsupervised participation (Podsiadlo & Richardson, 1991).
Anyone who gets a time >30seconds will be informed that they cannot participate.
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Baseline, 8 and 12 weeks
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1-minute sit-to-stand test
大体时间：Baseline, 8 and 12 weeks
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The 1-minute sit-to-stand test is a measure of exercise capacity that has been validated with individuals living with COPD (Puhan et al., 2013).
Individuals sit on a standard chair without arm rests, with their legs hip-width apart and about 90 degrees knee flexion and aligned and are asked to hold their hands stationary on their hips.
Participants are then asked to stand and sit 1-2 times to familiar themselves with the movement.
Then, for the duration of 1 minute, participants are asked to do as many repetitions as possible of the sit to stand, without using arms for support.
The number of repetitions is recorded.
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Baseline, 8 and 12 weeks
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Handgrip Test
大体时间：Baseline, 8 and 12 weeks
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To measure handgrip strength, we will use a Hand Dynamometer that will be sent to participants.
Individuals sit with their shoulders adducted, elbows flexed to 90˚ and forearms in a neutral position (Puhan et al., 2013).
They are then asked to squeeze the handle as much as possible and read to the nearest kilogram where the needle stopped, which is then recorded.
The best of six measurements is used as an indication of upper body strength.
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Baseline, 8 and 12 weeks
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Borg Scale - Dyspnea
大体时间：Baseline, 8 and 12 weeks
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On a scale from 0-10, participants' indicate their breathlessness level.
0- No breathlessness at all to 10- Maximal breathlessness
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Baseline, 8 and 12 weeks
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Godin Leisure Time Physical Activity Questionnaire
大体时间：Baseline, 8, and 12 weeks
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Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.
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Baseline, 8, and 12 weeks
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The Psychological Need Satisfaction in Exercise scale
大体时间：Baseline, 8, and 12 weeks
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This 1-6 scale represents different feelings people have when they exercise.
1-true to how they typically feel when exercising, and 6-false to how they typically feel when exercising.
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Baseline, 8, and 12 weeks
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The Treatment Self-Regulation Questionnaire
大体时间：Baseline, 8, and 12 weeks
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This 7 point scale relates to the reasons why one would either start to exercise regularly or continue to do so.
1- not at all true to the reason why they would exercise regularly, and 7- Very to true to the reason why they would exercise regularly.
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Baseline, 8, and 12 weeks
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Social Support from Peer Support Group Questionnaire
大体时间：8 and 12 weeks
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This 4 point scale measures how often during the past 4 weeks peers (i.e.
other people with COPD) have provided informational and emotional support to the participant.
1- Never provided the support described and 4- Very often provided the support described.
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8 and 12 weeks
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Medical Research Council Questionnaire on Breathlessness (mMRC)
大体时间：Baseline, 8, and 12 weeks
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This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.
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Baseline, 8, and 12 weeks
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COPD Assessment Test (CAT)
大体时间：Baseline, 8, and 12 weeks
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This questionnaire was used to measure the impact COPD is having on well being and daily life.
The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful.
Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.
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Baseline, 8, and 12 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Activities, Healthcare, and Research Priorities Survey
大体时间：Baseline, 8, and 12 weeks
|
Participants will answer 26 questions based on daily and social activities and be asked if they participate in said activity.
Responses include: Yes - as much as I want.
Yes - but less than I want.
No - but I would like to do it.
No - and I don't want to do it.
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Baseline, 8, and 12 weeks
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Three Factor Social Identity Questionnaire
大体时间：8, and 12 weeks
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This 7 point scale measures feelings about being a part of the exercise and peer support group.
1-strongly disagree and 7- strongly agree to indicate agreement with each of the statements.
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8, and 12 weeks
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The Acceptability of Intervention Measure (AIM)
大体时间：8, and 12 weeks
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The Acceptability of Intervention Measure will be administered to measure high acceptability and satisfaction with the intervention.
Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.
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8, and 12 weeks
|
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Intervention Appropriateness Measure (IAM)
大体时间：8, and 12 weeks
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The Intervention Appropriateness Measure will be administered to measure high acceptability and satisfaction with the intervention.
Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.
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8, and 12 weeks
|
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Feasibility of Intervention Measure (FIM)
大体时间：8, and 12 weeks
|
The Feasibility of Intervention Measure will be administered to measure high acceptability and satisfaction with the intervention.
Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.
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8, and 12 weeks
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6-Item Health Care Climate Questionnaire
大体时间：4, 8, and 12 weeks
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This 7 point scale measures how strongly the participant experienced interest, intrigue, focus, enjoyment, and annoyance during their participation in he Functional Tasks and Peer Support Intervention.
1-not at all experienced during the intervention to 7-extremely experienced during the intervention.
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4, 8, and 12 weeks
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Behaviour Change Technique Usage Questionnaire
大体时间：baseline, 8, and 12 weeks
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Participants completed a questionnaire that asked them to rate on a scale from 1 (not once) to 5 (daily) how frequently they have used goal setting, action planning, coping planning, physical restructuring, self monitoring, values identification, social restructuring, resource finding, and self belief in the past two weeks,
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baseline, 8, and 12 weeks
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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：Shane Sweet, Ph.D、McGill University
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)
2021年9月9日
初级完成 (实际的)
2022年1月31日
研究完成 (实际的)
2022年1月31日
研究注册日期
首次提交
2021年8月27日
首先提交符合 QC 标准的
2021年9月12日
首次发布 (实际的)
2021年9月14日
研究记录更新
最后更新发布 (实际的)
2022年2月24日
上次提交的符合 QC 标准的更新
2022年2月7日
最后验证
2022年2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.