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临床试验/NCT01801956
NCT01801956Unknown不适用

The MILE Study: A Motivational, Individual and Locally Anchored Exercise Intervention Among 30-49 Year-olds With Low Levels of Cardiorespiratory Fitness. A Randomised Controlled Study in Primary Care.

University of Aarhus4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
试验地点
4
主要终点
Maximum oxygen uptake

研究概览

简要总结

Background: Low levels of cardiorespiratory fitness are associated with high risk of non-communicable diseases and all-cause mortality. Physical activity level is the primary determinant of cardiorespiratory fitness in adults. However, knowledge on how to motivate people to engage in physical activity and maintain an active lifestyle is lacking. This study aims to investigate whether a motivational, individual, and locally anchored exercise intervention, in primary care, can improve cardiorespiratory fitness in 30 to 49 year olds with a low or very low cardiorespiratory fitness.

Design: Randomised controlled trial with 6 and 12 months follow-up. The primary outcome is cardiorespiratory fitness. Secondary outcomes include biochemical parameters (HbA1C, HDL- and LDL-cholesterol, and triglyceride), physical activity level (measured by accelerometer), self-reported physical activity, anthropometric parameters and health-related quality of life.

Methods: Cardiorespiratory fitness will be estimated via a maximal incremental exercise test and expressed as the index of maximum oxygen uptake per minute divided by body weight (ml O2/kg/min). A total of 236 participants, classified with a very low or low cardiorespiratory fitness at a local health check programme, (corresponding to ≤ 39 and ≤35 ml O2/kg/min. for 30-39 and 40-49 year-old men respectively and ≤33 and ≤31 ml O2/kg/min. for 30-39 and 40-49 year-old women respectively), will be randomised into two groups. The intervention group will receive 4 motivational interviews, six months membership to a sport club, and a global positioning watch to upload training activity to a social media. The comparison group will receive standard care: a one hour motivational interview. In addition to an Intention-to-treat analysis a per-protocol analysis will be performed. Effect of the intervention will be estimated by evaluating the differences in mean changes in cardiorespiratory fitness between the two groups.

Discussion:In new and innovative ways the focus of this study will be to improve cardiorespiratory fitness among a 30-49 year-old at-risk group using social media, GPS-technology, on-going personal support and individually tailored physical activity.

详细描述

Background It is well known that low levels of cardiorespiratory fitness are associated with a high risk of noncommunicable diseases and all cause mortality, and that improvements in cardiorespiratory fitness decreases this risk especially among the least fit (1-5). Although cardiorespiratory fitness has a genetic contribution, physical activity habits are the primary determinant of cardiorespiratory fitness in adults, and changes in physical activity levels result in changes in cardiorespiratory fitness (2,6). Thus the World Health Organization recommends adults aged between 18-64 to do at least 150 minutes of moderate-intensity aerobic physical activity or at least 75 minutes of vigorous-intensity aerobic physical activity weekly or an equivalent combination of moderate- and vigorous-intensity activity. In Denmark only an estimated 32 % fullfill these recommendations (7) and improving physical activity among this group of people is of great importance to public health.

In primary care several simple- and multicomponent physical activity interventions have been conducted in order to increase physical activity. However, the results of these interventions remain inconsistent. In addition, the content of the interventions is often unclearly described, particularly in relation to intensity and fidelity of the intervention delivery and reviews reveal how most of the studies use self-reported measures of physical activity (8,9). These issues warrant well-described intervention studies using objectively measures of physical activity and specifically designed for, and evaluated in primary care settings.

In Denmark, the "Check your health" programme is aimed at screening all individuals (n≈26,500) in the municipality of Randers aged between 30-49 years for cardiovascular disease during a 5-year period. Identifying people that are insufficiently active and people with a low cardiorespiratory fitness is one of the central objectives of the programme and this is done by self-reported and objective measures of physical activity and cardiorespiratory fitness.

To perform a successful intervention, strategies and techniques to motivate and guide people to adopt healthy choices need to be identified. Some of this may be accomplished by close supervision and personal instruction with healthcare professionals applying communication skills such as motivational interviewing (10,11), which has been found to be an effective approach to changing behaviour. This method specifically offers promise in improvement of cardiovascular health status (12).

Furthermore, a key issue will be to adopt modern technology and social media into the interventions (13). A Danish report supports this idea and concludes that particularly the 30-50 year olds, an age-group that does not always give high priority to regular physical activity due to lack of time and commitments such as job/further education and establishment of a family, are motivated by the social media and technology (14-16).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 30-49 years old
  • access to e-mail and internet
  • a low or very low VO2max

排除标准

  • health problems preventing participation
  • on medication with a beta-blocker
  • pregnancy
  • alcoholism
  • unable to communicate with the staff.

结局指标

主要结局

Maximum oxygen uptake

时间窗: Change from baseline maximum oxygen uptake at 6 and 12 months.

The outcome is measured by an indirectly standardized and validated max imalergometer bicycle test. The bicycle is cycled at 100 watt (women 70 watt). Every second minute the load is increased by 35 watt until the load causes fatigue. The highest load achieved, the time spent cycling at the highest load and the weight of the participant are put into a formula and the CRF is estimated

次要结局

  • Physical activity(Change from baseline physical activity at 6 and 12 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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