The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer (MOVE)
2016年4月21日 更新者：University of East Anglia
Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer
Long-term maintenance of physical activity behaviour change post-intervention remains challenging.
This study is investigating the feasibility of a behaviour change intervention based on Self-Determination Theory in people recovering from colorectal cancer and its effects on behaviour change 6 months post-intervention.
研究概览
详细说明
This study was a randomized controlled feasibility trial consisting of a 3-months active lifestyle intervention and a 3-months follow-up period. Participants were allocated to an active lifestyle programme (ALP) or the standard (SC) care group. ALP was offered 12 supervised exercise sessions over 3 months and six supportive behaviour change workshops. SC was encouraged to continue with their usual lifestyle. The intervention was informed by Self-Determination Theory.
The supervised exercise sessions took place in small groups of maximum 7 participants and lasted approximately 1 hour. Exercise included aerobic and resistance exercises. The behaviour change workshops were delivered in a motivational interviewing style, also in small groups of maximum 7 participants.
Participants were followed-up at 6 months. There was no contact with participants during the post-intervention and follow-up period.
研究类型
介入性
注册 (实际的)
28
阶段
- 不适用
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
- 孩子
- 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 histologically confirmed diagnosis of colorectal cancer with Dukes stages A-C
- completed cancer treatment within the last 24 months,
- be able to understand spoken and written English
- score of 80 or more on the Karnofsky Performance Status Scale
Exclusion Criteria:
- already meeting general PA guidelines of 150 min of moderate PA or 75 min of vigorous intensity PA per week,
- recent myocardial infarction
- uncontrolled hypertension
- a pacemaker
- or unstable angina.
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：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 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：Active Lifestyle Programme
Supervised exercises for 3 months and motivational interviewing to facilitate physical activity behaviour change.
Supervised exercise sessions took place twice per week for the first four weeks.
This was tapered off to once per week for the second four weeks.
During the last month of the intervention participants continued with the exercise at home and were encouraged to achieve 150min of moderate to vigorous PA per week.
|
The intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention.
其他名称：
|
|
无干预：Standard Care
Received usual care.
Was offered the intervention after the completion of the study.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
大体时间：0, 3, 6 months
|
0, 3, 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
大体时间：0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
大体时间：0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in quality of life measure with the Functional Assessment of Cancer Therapy general
大体时间：0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
大体时间：0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
大体时间：0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in intention to exercise
大体时间：0, 3, 6 months
|
assessed with Intention to exercise scale
|
0, 3, 6 months
|
|
Change in barriers to exercise
大体时间：0, 3, 6 months
|
assessed with Barriers to Exercise scale
|
0, 3, 6 months
|
|
Change in physical fitness
大体时间：0, 3, and 6 months
|
assessed with the modified Bruce treadmill test
|
0, 3, and 6 months
|
|
Change in upper body strength-grip strength
大体时间：0, 3, 6 months
|
Assessed with grip dynanometer
|
0, 3, 6 months
|
|
Change in upper body strength-upper arm strength
大体时间：0, 3, 6 months
|
Assessed with biceps curl test
|
0, 3, 6 months
|
|
Change in lower body strength
大体时间：0, 3, 6 months
|
Assessed with 30 sec sit-to-stand test
|
0, 3, 6 months
|
|
Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
大体时间：0, 3, 6 months
|
0, 3, 6 months
|
|
|
Change in antropometric measures (waist circumference, hip circumference
大体时间：0, 3, 6 months
|
Waist and hip circumference will be used to calculate the waist-to-hip ratio
|
0, 3, 6 months
|
|
Changes in anthropometric measures (height, weight, BMI)
大体时间：0, 3, 6 months
|
Body weight and body height will be used to calculate BMI
|
0, 3, 6 months
|
|
Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
大体时间：0, 3, 6 months
|
0, 3, 6 months
|
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：John M Saxton, PhD、Northumbria University, Newcastle, United Kingdom
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
2013年10月1日
初级完成 (实际的)
2014年9月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2016年4月21日
首先提交符合 QC 标准的
2016年4月21日
首次发布 (估计)
2016年4月26日
研究记录更新
最后更新发布 (估计)
2016年4月26日
上次提交的符合 QC 标准的更新
2016年4月21日
最后验证
2016年4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.
Active lifestyle programme的临床试验
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Sophiahemmet UniversityKarolinska Institutet; Linnaeus University; The Swedish School of Sport and Health Sciences; Stockholm... 和其他合作者尚未招聘