Cardio Training of Older Adults With Central Obesity
2018年2月28日 更新者：Anna Nordström、Region Västerbotten
Given the increasing prevalence of obesity, there is an urgent need to find better strategies to promote physical activity in the community.
The present study will invite 70-year-olds with central (abdominal) obesity to participate in a 10-week aerobic exercise program.
Participants will be randomly assigned to one of two equally large groups.
The first group will complete the exercise program in instructor-led groups.
The second group will complete the program at home with the help of an on-line video.
研究概览
详细说明
Central obesity means having a lot visceral fat, that is, fat located in the abdominal cavity. Visceral fat is a well-established risk factor for cardiovascular disease and all-cause mortality.
Participants will be recruited from the Healthy Ageing Initiative (HAI), an ongoing population-based study that invites all 70-year-olds in Umeå, Sweden, to a health examination. The exercise program will focus is on station-based aerobic exercises and resistance exercises, predominantly with participants' own body weight as resistance. The program is progressive, starting at a moderate pace so that participants learn to perform the exercises properly. The intensity will be aimed at 60-80% of maximal exhaustion, and each exercise bout will last 60 seconds with 20 seconds of rest between bouts. The program was developed by seniors in the bachelor's program in exercise physiology at Umeå University, Sweden.
研究类型
介入性
注册 (预期的)
80
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
-
-
Västerbotten
-
Umeå、Västerbotten、瑞典、907 36
- Livsmedicin (LIFE)
-
-
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
70年 至 70年 (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:
- Participated in the Healthy Ageing Initiative (a population-based intervention study in Umeå, Sweden)
- Visceral adipose tissue mass >1 kg (women) or >2 kg (men)
Exclusion Criteria:
- Physical disability that affects ability to perform the exercises
- Heart failure or severe degenerative condition (e.g. malignant cancer or multiple sclerosis)
- Myocardial infarction or stroke in the past year
- Heart condition that can worsen with aerobic exercise (e.g. 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：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 |
|---|---|
|
实验性的：Intervention Group
Weeks 1-10: exercise program in group.
Weeks 11-20: no intervention.
Weeks 21-31: no intervention.
|
An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
|
|
实验性的：Control group
Weeks 1-10: no intervention.
Weeks 11-20: no intervention.
Weeks 21-31: exercise program at home.
|
An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
|
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 |
|---|---|---|
|
Change in visceral adipose tissue mass
大体时间：0, 10, 20, and 31 weeks
|
Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA).
|
0, 10, 20, and 31 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in body composition
大体时间：0, 10, 20, and 31 weeks
|
Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA)
|
0, 10, 20, and 31 weeks
|
|
Change in Body Mass Index (kg/m^2)
大体时间：0, 10, 20, and 31 weeks
|
0, 10, 20, and 31 weeks
|
|
|
Change in blood pressure (mmHg)
大体时间：0, 10, 20, and 31 weeks
|
Taken after 15 min of rest
|
0, 10, 20, and 31 weeks
|
|
Change in blood-lipid profile
大体时间：0, 10, 20, and 31 weeks
|
0, 10, 20, and 31 weeks
|
|
|
Change in fasting blood glucose
大体时间：0, 10, 20, and 31 weeks
|
Veinous blood samples taken after > 4 h of fasting
|
0, 10, 20, and 31 weeks
|
|
Change in isometric muscle strength
大体时间：0, 10, 20, and 31 weeks
|
Measured in non-dominant hand with dynamometer (Jamar, Lafayette Instrument, USA).
The better of two successive trials will be recorded.
|
0, 10, 20, and 31 weeks
|
|
Change in physical capacity
大体时间：0, 10, 20, and 31 weeks
|
Measured using Åstrands Submaximal Test, performed on an electrically braked ergometer bicycle
|
0, 10, 20, and 31 weeks
|
|
Change in resting metabolic rate
大体时间：0, 10, 20, and 31 weeks
|
As measured by indirect calorimetry
|
0, 10, 20, and 31 weeks
|
|
Change in health-related quality of life
大体时间：0, 10, 20, and 31 weeks
|
As measured by RAND-36
|
0, 10, 20, and 31 weeks
|
|
Change in self-reported physical activity
大体时间：0, 10, 20, and 31 weeks
|
Assessed using IPAQ-SF
|
0, 10, 20, and 31 weeks
|
|
Change in Microbiota composition
大体时间：0, 10, 20, and 31 weeks
|
Fecal samples are taken and bacterial DNA is sequenced to determine bacterial composition
|
0, 10, 20, and 31 weeks
|
|
Change in dietary habits
大体时间：0, 10, 20, and 31 weeks
|
85 item food frequency questionnaire
|
0, 10, 20, and 31 weeks
|
|
Change in concentration of inflammatory markers
大体时间：0, 10, 20, and 31 weeks
|
0, 10, 20, and 31 weeks
|
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。
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。
一般刊物
- Ballin M, Hult A, Bjork S, Lundberg E, Nordstrom P, Nordstrom A. Web-based exercise versus supervised exercise for decreasing visceral adipose tissue in older adults with central obesity: a randomized controlled trial. BMC Geriatr. 2020 May 12;20(1):173. doi: 10.1186/s12877-020-01577-w.
- Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of interval training on quality of life and cardiometabolic risk markers in older adults: a randomized controlled trial. Clin Interv Aging. 2019 Sep 4;14:1589-1599. doi: 10.2147/CIA.S213133. eCollection 2019.
- Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of Interval Training on Visceral Adipose Tissue in Centrally Obese 70-Year-Old Individuals: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1625-1631. doi: 10.1111/jgs.15919. Epub 2019 Apr 23.
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)
2018年2月9日
初级完成 (预期的)
2018年9月28日
研究完成 (预期的)
2018年9月28日
研究注册日期
首次提交
2018年2月16日
首先提交符合 QC 标准的
2018年2月28日
首次发布 (实际的)
2018年3月1日
研究记录更新
最后更新发布 (实际的)
2018年3月1日
上次提交的符合 QC 标准的更新
2018年2月28日
最后验证
2018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.