Aktiv i Sør: a Randomized Controlled Trial (AiS)
2017年5月23日 更新者：Monica Klungland Torstveit、University of Agder
The Effect of a Tailored Telephone and Email Based Physical Activity Intervention on Physical Fitness and Body Composition: a Randomized Controlled Trial
The purpose of this regional parallel-group RCT was to assess the effect of a six-month tailored telephone and email based physical activity intervention on various measures of physical fitness and body composition in a sample of physically inactive adults.
A total of 111 physically inactive adults (40-55yr) from Agder, Norway were randomly allocated to either an intervention group (IG;n=56) or a no-intervention control group (CG;n=55).
The IG received tailored exercise recommendations, every two months by email or mail (print) in addition to motivational follow-ups every second week, alternatively by email and telephone.
Primary outcome measures were various objective measures of musculoskeletal and cardiorespiratory fitness in addition to various measures of body composition, including waist circumference, body mass index and fat percentage, which were assessed pre- and post-intervention.
研究概览
研究类型
介入性
注册 (实际的)
111
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
40年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Participants were included in the study if they were
- healthy
- between the ages of 40-55
- residents of the Agder counties in Norway
- classified as physically inactive (not fulfill the recommendations for physical activity given by the Norwegian Directorate of Health
- within stage one to three of the five stages of change in the transtheoretical model stages of change
Exclusion Criteria:
Participants were excluded if they were
- Unhealthy/ill
- younger than 40 years or older than 55 years
- living outside the Agder counties in Norway
- allready fulfilling the national recommendations given by the Norwegian Directorate of Health
- within stage four or five of the five stages of change in the transtheoretical model stages of change
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：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention group - telephone and print exercise intervention
The intervention group (IG) received a total of three intervention packages, one every second month, during the intervention period.
The first intervention package was distributed at intervention start.
The intervention package consisted of a tailored exercise program, national recommendations for physical activity, prompts and reminders.
Additionally the IG received fortnightly supportive motivational contact every two weeks, alternately by telephone og email
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Intervention has previously been described.
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无干预：Control group
The control group (CG) were encouraged to continue previous lifestyle.
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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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Change from Baseline Cardiorespiratory fitness at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Cardiorespiratory fitness was measured by a modified Balke protocol on a treadmill and registered in ml/kg/min
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Muscular endurance of the back extensors at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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The static back extension test recorded muscular endurance of the back extensors as number of seconds the subject managed to endure a static horizontal position, with their lower body supported by a bench (max 240 sec).
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Hand grip strength at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Hand grip strength was registered to the nearest 1 kilogram (kg) using a hydraulic dynamometer
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Neuromotor fitness at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Neuromotor fitness was registered using the one leg standing test where the duration each subject managed to hold a balancing position was recorded in seconds (max 60 seconds).
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Muscular dynamic endurance of and the ability to stabilize the upper body at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Muscular dynamic endurance of and the ability to stabilize the upper body was registered using a modified push-ups test.
The amount of correctly performed repetitions completed in 40 seconds, was recorded in number.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Flexibility of the hamstring musculature at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Flexibility of the hamstring musculature was recorded using the sit-and-reach test to the nearest half centimeter, using a specially designed box.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Flexibility in the shoulder joint at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Flexibility of the shoulder joint was registered to the nearest centimeter, using the back-scratch test.
The mean registered flexibility score of both shoulders was recorded.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Explosive power in the lower extremities at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Explosive power in the lower extremities was recorded to the nearest centimeter, using the vertical jump test.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Body mass index at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Body mass index was calculated using the formula weight/height^2.
Height and weight were measured using a measuring band (meters) and a weight scale (kilograms) respectively.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Waist circumference at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Waist circumference was registered using a measuring band and the mean of two measures was recorded to the nearest half-centimeter.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Fat percentage at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Fat percentage was measured using the bioimpedance machine InBody 720 and using skinfolds.
Both registered body fat percentage.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Cardiorespiratory fitness at 6 months
大体时间：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Cardiorespiratory fitness was measure by a modified Balke protocol on a treadmill and registered in l/min.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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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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Age
大体时间：This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
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Age was assessed by questionaire to the nearest whole year.
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
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Gender
大体时间：This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Gender was assessed using a questionnaire and outcome was either Female or male.
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Educational level
大体时间：This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Educational level was assessed using a questionnaire as one of four different levels
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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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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Physical activity level
大体时间：This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Physical activity level was assessed using IPAQ- sf as minutes of physical activity per week.
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This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Stage of change
大体时间：This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Stage of change was assessed using a questionnaire as one of five alternatives.
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This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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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：Monica K Torstveit, PhD、University of Agder
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)
2011年4月1日
初级完成 (实际的)
2011年10月1日
研究完成 (实际的)
2012年2月1日
研究注册日期
首次提交
2017年3月9日
首先提交符合 QC 标准的
2017年5月19日
首次发布 (实际的)
2017年5月23日
研究记录更新
最后更新发布 (实际的)
2017年5月25日
上次提交的符合 QC 标准的更新
2017年5月23日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
其他研究编号
- Aktiv i Sør
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
The IPD of the present study will be shared through publications (articles).
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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