The Effects of a 4-week Vinyasa Yoga Program on Sleep and Cardiovascular Health in Adults With Insomnia Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index
研究概览
简要总结
The purpose of our study is to examine the effects of a 4-week vinyasa yoga program on sleep-related and cardiovascular outcomes in adults with insomnia symptoms. This study will examine the following aims:
To examine the effects of a 4-week vinyasa yoga program compared to a non-active control condition on subjective and objective sleep-related outcomes in adults who report insomnia symptoms.
To examine the effects of a 4-week vinyasa yoga program compared to a non-active control on cardiovascular health.
To examine the effects of a single session of vinyasa yoga compared to a non-active control condition on sleep- and cardiovascular-related outcomes collected overnight.
Researchers will compare the yoga group and the non-active control group to see if there are any improvements in sleep and cardiovascular health.
详细描述
This study will examine the effects of a 4-week vinyasa yoga program on sleep-related and cardiovascular outcomes using a randomized parallel group design. Following baseline assessments, participants will be randomly assigned into one of the two experimental conditions (i.e., vinyasa yoga, non-active control condition) based on stratification by sex (i.e., male, female) in a 1:1 ratio.
All groups will complete an initial in-person experimental session during the early evening: those in the vinyasa yoga group will be guided through a supervised vinyasa yoga session and those in the non-active control group will complete a quiet rest session. Participants will be provided an Actiwatch and heart rate monitor to measure acute experimental effects on sleep and nocturnal heart rate variability.
Following the initial supervised session, those in the vinyasa yoga intervention will be provided with a yoga mat and a standardized video and asked to practice 3 times per week for 4 weeks; compliance will be monitored by an online log. The non-active control group will not receive any yoga intervention and will be asked to avoid starting a new exercise routine.
Following the 4-week intervention, all participants will complete post-intervention sleep and cardiovascular assessments following the same procedures used at baseline.
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 (Outcomes Assessor)
盲法说明
The research staff conducting the outcome assessments will be blinded to the participant intervention group assignment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insomnia Severity Index (ISI) score ≥ 10
- •Age 18-55 years
- •Insufficiently active defined by the Stanford Leisure-Time Activity Categorical Item responses below public health physical activity guidelines
排除标准
- •Self-reported regular vinyasa and/or power yoga practice defined as ≥ 60 minutes/week within the past 3 months
- •Diagnosed medical condition requiring medical clearance defined as a 'yes' response on follow-up questions pertaining to a present medical condition(s) via Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
- •Physical limitations and/or mobility restriction that would interfere with the ability to perform yoga defined as a 'yes' response on the PAR-Q+; self-reported lack of treatment for a major psychiatric disorder via medical history survey
- •High risk for obstructive sleep apnea defined as score ≥ 5 via STOP-Bang score
- •Self-reported current pregnancy or planning to become pregnant within the next 3 months
- •Overnight shift work defined as regularly working any time between 00:00 and 06:00 am
- •Self-reported current treatment for insomnia via medical history survey
- •Medications that may affect heart rate during exercise via self-report on the medical history survey
结局指标
主要结局
Change in Insomnia Severity Index
时间窗: Baseline, post-intervention (4 weeks)
Insomnia Severity Index is a 7-item self-report questionnaire that assesses the severity of the nighttime and daytime impact of insomnia symptoms. Each question is rated on a 5-point Likert scale, with a score of 0 indicating 'no problem' and 4 indicating 'very severe'. The total score is obtained by summing the scores of the individual items ranging from 0 to 28; a higher score indicates more severe insomnia symptoms.
Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD)
时间窗: Baseline, post-intervention (4 weeks)
Nocturnal root mean square of successive difference between normal heartbeats will be assessed for 1 night with a Polar heart rate monitor strap; an increase indicates better cardiovascular health
次要结局
- Change from baseline in Epworth Sleepiness Scale(Baseline, post-intervention (4 weeks))
- Change from baseline in Generalized Anxiety Disorder-7 Questionnaire(Baseline, post-intervention (4 weeks))
- Change from baseline resting carotid-femoral pulse wave velocity(Baseline, post-intervention (4 weeks))
- Change from baseline quality of sleep(Baseline, post-intervention (4 weeks))
- Change from baseline in Patient Health Questionnaire(Baseline, post-intervention ( 4 weeks))
- Change from baseline sleep efficiency at 4 weeks(Baseline, post-intervention (4 weeks))
- Change from baseline resting systolic blood pressure at 4 weeks(Baseline, post-intervention (4 weeks))
- Change from baseline in Ford Insomnia Response to Stress Test(Baseline, post-intervention (4 weeks))
- Change from baseline total sleep time at 4 weeks(Baseline, post-intervention (4 weeks))
- Change from baseline resting heart rate at 4 weeks(Baseline, post-intervention (4 weeks))
研究者
Caitlin Cheruka
Graduate Student Researcher
University of Pittsburgh