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临床试验/NCT05316571
NCT05316571招募中不适用

Sitting Interruption and Whole-body Cardiovascular Health: Linking Physiological Responses to Risk Behaviors

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
56
试验地点
1
主要终点
Mean Change in Carotid-femoral Pulse Wave Velocity (cfPWV)

研究概览

简要总结

There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk.

详细描述

Sedentary behaviors (SB) are biologically distinct but understudied heart disease risk factors. National and international agencies have concluded that the level of evidence for an overall and dose-response association between SB and heart disease mortality is moderate-strong. These agencies do not provide specific recommendations for breaking-up SB, though do call on the research community to facilitate policy development by establishing biological plausibility, identifying the optimal dose for SB substitution strategies, and conducting randomized clinical trials to test the efficacy of these strategies. Accordingly, the goal of this study is to identify mechanism-informed, socioecological-based SB substitution recommendations to reduce heart disease risk. To achieve this goal, two aims will be addressed. Aim 1 will identify a feasible SB substitution strategy to prevent the negative cardiovascular responses to prolonged SB (i.e., strategies that people will actually follow). Adverse cardiovascular responses to prolonged SB will be measured using aortic arterial stiffness (AS), a noninvasive test that predicts future heart disease. To accomplish this aim, 56 middle-aged (30-60 years) participants will provide written informed consent, prior to the measurement of aortic AS and associated mechanistic responses to the following over 4 hours, in a randomized crossover manner: (i) SB with a 5-minute walk break once per hour; (ii) SB with a 15-minute standing break once per hour; (iii) SB with two breaks per hour, alternating between a 5-minute walk and a 15-minute stand; and (iv) SB with no breaks (control). These strategies were selected based on extensive prior work by the investigators, and because they are feasible, which is a key component of this study. SB reduction strategies will only decrease heart disease risk if people are willing to adhere to future SB substitution recommendations. To increase the likelihood of feasibility and long-term adherence, Aim 2 will evaluate the determinants of SB using a socioecological model. This recognizes that behavior change is likely to be limited if the physical and sociocultural environments do not support the behavior change. To accomplish Aim 2, a combined inductive-deductive qualitative approach will be used. Participants who complete Aim 1 will participate in one of 6 focus groups (6-8 participants/group). Crucially, the outcomes from this proposal will be instrumental in helping to design a subsequent clinical trial to test a mechanism-informed yet feasible SB reduction intervention, and in doing so directly support the development of SB policy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Researchers and participants will be blinded to the condition until each day of testing, and the statistician and any technicians processing outcome data will be blinded to the condition.

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 30-60 years
  • Insufficiently active: self-reported exercise <90 minutes per week for the past 3 months
  • Sedentary: self-reported sitting >8 hours per day
  • Self-reported ability to walk 4 blocks and climb 2 flights of stairs
  • Possession of cellular phone able to receive text messages

排除标准

  • Use of assisted-walking devices
  • Comorbid condition that would limit the ability to reduce sedentary behavior (e.g., musculoskeletal condition, current chemotherapy)
  • Plans for major surgery within next 3 months
  • Recent history (<1 year) of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
  • Recent (< 1 year) or planned bariatric surgery
  • Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
  • Current or recent (within last 6 months) pregnancy; current or recent (within last 3 months) breastfeeding
  • Morbidly obesity (BMI >40 kg/m^2) or underweight (BMI <18.5 kg/m^2)
  • Use of anti-hypertensive drugs
  • Use of glucose-controlling medication
  • Heavy alcohol consumption (>15 drinks per week)

研究组 & 干预措施

One 5-Minute Walking Bout Each Hour

Active Comparator

A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary.

The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.

干预措施: One 5-Minute Walking Bout Each Hour (Behavioral)

One 15-Minute Standing Bout Each Hour

Active Comparator

A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary.

The interruption strategy includes breaking up the 4-hour sitting bout with one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.

干预措施: One 15-Minute Standing Bout Each Hour (Behavioral)

One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour

Active Comparator

A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary.

The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout and one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.

干预措施: One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour (Behavioral)

Uninterrupted Sitting

Active Comparator

A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary.

This uninterrupted sedentary bout will serve as a control. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.

干预措施: Uninterrupted Sitting (Behavioral)

结局指标

主要结局

Mean Change in Carotid-femoral Pulse Wave Velocity (cfPWV)

时间窗: Measurements will be taken immediately before and after each 4-hour SB condition

cfPWV (m/sec) will be measured between the carotid and femoral arteries, using a collar around the neck and a cuff around the thigh, with the participant in a supine position. cfPWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements

次要结局

  • Mean Change in Femoral-ankle PWV(Measurements will be taken immediately before and after each 4-hour SB condition)
  • Change in Heart-middle Cerebral Artery Pulse Wave Velocity (Brain PWV)(Measurements will occur continuously throughout each of the 4-hour SB conditions)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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