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临床试验/NCT03428542
NCT03428542已完成不适用

The Effects of Yoga on Psychological and Physiological Health in a Population Based Cohort

Region Skane2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
105
试验地点
2
主要终点
Pulse-wave velocity

研究概览

简要总结

This study aims to evaluate the benefits of yoga as a 'mind-body' practice, by measuring it's effects on health-related psychological and physiological variables. The study also aims to investigate whether an association exists between subjective (psychological) and objective (physiological) measures, with a particular focus on stress as the primary outcome.

详细描述

Stress and worry in everyday life are common features of Western society. Stress is a biological mechanism tapping the fight-or-flight-response via activation of the sympathetic nervous system. When exposed to stress during prolonged periods of time, the immune system is affected, leading to physiological as well as psychosocial problems. The consequences of untreated high stress can not only turn into reduced job capacity, and work roles conflicts, but also into cardiovascular disease, and mental illness such as an anxiety disorder or/and depression.

One common and recommended strategy to manage stress is to exercise regularly. Yoga is an umbrella term for a wide variety of physical, mental, and spiritual practices with its roots in ancient India. Most previous research on the health effects of yoga has demonstrated benefits on psychological health factors including mental stress, anxiety, depression and sleep problems.

The aim of the study is thus to investigate the effects of two types of yoga intervention on psychological and physiological health.

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
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A score on four items of the Perceived Stress Scale between 8-16, thereby indicating a current stress experience of at least moderate level.
  • Ability to participate in the intervention during the time-period.
  • Comprehensive in Swedish.

排除标准

  • Ongoing yoga practice or any regular practice of yoga or meditation within the last 6 months.
  • Any known physical limitations that may prevent light physical activity (yoga postures).
  • Current psychological or psychopharmacological treatment.
  • Inability to attend more than 5 of the scheduled 10 yoga sessions.

结局指标

主要结局

Pulse-wave velocity

时间窗: 5 weeks

Measured using a sphygmocor device.

The Hospital Anxiety and Depression Scale

时间窗: 5 weeks

A fourteen item scale which assesses levels of anxiety and depression. Seven of the 14 items relate to anxiety and seven relate to depression. Each item is scored from 0-3. Items can be scored together by subscale (score range: 0-21), or for total scale score (score range: 0-42).

General Health Questionnaire

时间窗: 5 weeks

Consists of 12 items, each one assessing the severity of a mental problem over the past few weeks using a 4-point Likert-type scale (from 0 to 3). These scores generate a total score ranging from 0 to 36 where higher scores indicate worse health.

The Harmony in Life Scale

时间窗: 5 weeks

Assesses a global sense of harmony in one's life and consists of 5 statements for which participants are asked to indicate degree of agreement on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The harmony score is established by summarizing the 5 statements for each participant, allowing for a maximum score of 35 (range: 5 - 35). Higher scores represent greater harmony in life.

The Kentucky Inventory of Mindfulness Skills -Short Version

时间窗: 5 weeks

A 20-item multi-dimensional scale of interrelated skills related to what one does while practicing mindfulness, and how one does it.

The Brief Experiential Avoidance Questionnaire

时间窗: 5 weeks

A questionnaire which consists of 15 items used to assess behavioral avoidance , distress aversion, procrastination, distraction/suppression, repression/denial, and distress endurance. Participants are asked to indicate degree of agreement on a 6-point Likert scale (1 = strongly disagree, 6 = strongly agree). The score is established by summing all items (score range: 15 - 90).

The Self-Compassion Scale

时间窗: 5 weeks

A 26-item measure with six subscales, tapping the construct of self-compassion. The subscales are self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Scores of subscales are added together for a total score representative of the level of self-compassion.

Perceived Stress Scale

时间窗: 5 weeks

A 10-item scale measuring the degree to which situations in one's life are appraised as stressful.The items are rated on a 5-point scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating a higher stress level.

The COPE Inventory

时间窗: 5 weeks

Assesses 14 conceptually distinct coping strategies. It includes 13 scales with four items each and one single item question to assess different strategies for coping with stress. All items are reported on a 4-point scale.

The Insomnia Severity Index

时间窗: 5 weeks

A brief screening measure of insomnia and an outcome measure for use in intervention research. The index contains seven items rated on a five-point Likert scale from 0 to 4. Higher scores indicate symptoms of insomnia.

Diet

时间窗: 5 weeks

A 2-item measure that is used as an exploratory questionnaire. The questions are as follows: Have you changed your eating habits since you started your participation in the study? Categorical answer choices include 1) No, not at all, 2) Yes, to some extent, 3) Yes, to a great extent. A second question is open-ended: If you have changed your eating habits, please describe how. This very brief questionnaire will be given only once at the end of the study to explore whether dietary changes have occurred following the 5-week study period.

Fasting blood sampling

时间窗: 5 weeks

A total of 3 tubes will be collected for each participant, amounting to a total of 65ml of blood per person. Blood analysis will include stress hormones, inflammatory biomarkers, metabolic profiling, cardiometabolic biomarkers, cholesterol, triglycerides, creatinine, catecholamines (noradrenalin and adrenalin), renin, cortisol, and glucose concentration.

Fasting and 120-minute glucose tolerance test (mmol/L)

时间窗: 5 weeks

The glucose tolerance test determines how the body responds to glucose (sugar). After a fasting blood sample is taken (see above procedure), participants will be asked to drink a liquid containing glucose. A second blood sample will be taken 120 minutes later.

Office and 24-hour blood pressure measurement (mmHg)

时间窗: 5 weeks

Blood pressure measurements will be taken periodically by the device for a period of 24-hours.

Gut microbiota

时间窗: 5 weeks

Fecal samples.

Heart rate variability

时间窗: 5 weeks

Measured with electrocardiogram during deep breathing. Heart rate variability is is the variation in the time interval between heartbeats.

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olle Melander

Professor

Region Skane

研究点 (2)

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