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临床试验/NCT04353700
NCT04353700已完成不适用

Does a 12-week Home-based Dynamic Yoga Intervention Improve Bone and Cardiovascular Health in Healthy Premenopausal Women? A Randomized Controlled Feasibility Study

University of Massachusetts, Lowell2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Change in total fat mass was assessed

研究概览

简要总结

While effects of specific exercise interventions on bone and CVD in postmenopausal women have been demonstrated and evaluated, the effects of randomized controlled exercise interventions, particularly in middle-aged premenopausal women are sparse. Therefore, it is imperative to examine the relation between behavioral interventions and bone and cardiovascular outcomes in premenopausal women as this understudied group is at high risk for the initial stages of bone loss and cardiovascular disease development.

详细描述

Presently, it is not clear whether the intensity of Yoga interventions is high enough to induce positive effects on bone and cardiovascular health in a healthy population. For example, Hagins et al. (2007) reported that the metabolic costs of Hatha Yoga, averaged across the entire session, represent low levels of physical activity (walking). On the other hand, Ashtanga Yoga, or power Yoga, is performed at a higher intensity than Hatha Yoga and has been shown to elicit significantly higher heart rates than either Hatha or gentle Yoga (Cowen and Adams, 2007). Sun Salutations (SS) are an example of an Ashtanga Yoga sequence, where yoga postures are performed dynamically with combinations of forward and backward bending poses (Omkar et al., 2011). A previous 8-month yoga intervention found that regular long-term Ashtanga yoga had a small positive effect on bone formation in premenopausal women. Although Yoga has the potential to be an alternative physical activity to improve bone health and arterial stiffness, there is a lack of high-quality evidence for this type of intervention. Thus, the purpose of this study is to assess the feasibility of a 12-week home-based dynamic yoga intervention designed to improve bone metabolism and arterial stiffness in healthy premenopausal women.

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
30 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants were healthy premenopausal women volunteers between the ages of 30 and 48 years.
  • Participants were free of chronic back or joint problems, cardiovascular disease, non-smokers, not pregnant, not taking antihypertensive drugs or any medication that affects bone density.
  • Participants didn't have regularly participated in a weight training program and yoga exercise at least 12 months prior to the study.
  • Participants were medically stable, ambulatory, and capable of training.

排除标准

  • Individual who were outside of the 30-48 years age range and who exceed the weight limit of the DXA (300 pounds).
  • Individuals who did not have the regular menstrual cycles.
  • Pregnancy or the possibility of becoming pregnant during the intervention period
  • Individuals who were taking medications known to affect bone metabolism such as steroid hormones, calcitonin, or corticosteroids.
  • Any persons with physical and mental disabilities preventing them from being trained, including orthopedic or arthritic problems, were not allowed to participate.
  • Individuals whose radiation exposure from medical and/or research tests in the previous year exceeds the recommended regulator limit.

结局指标

主要结局

Change in total fat mass was assessed

时间窗: Total fat mass was measured at baseline and after 12 weeks.

Total fat mass (g) was measured using Dual Energy-X-ray Absorptiometry.

Change in Health history was assessed.

时间窗: HH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.

A health history questionnaire (HH) was utilized to examine any medical history that can affect bone and cardiovascular health.

Change in %fat was assessed

时间窗: %fat was measured at baseline and after 12 weeks.

%fat (%) was measured using Dual Energy-X-ray Absorptiometry.

Change in Physical activity participation was assessed.

时间窗: BPAQ scores were collected at baseline, at 6 weeks, and after 12 weeks to see any differences throughout the intervention periods.

Participants were asked to fill out a physical activity questionnaire (BPAQ scores) Physical activity participation was estimated with the bone-specific physical activity questionnaire (BPAQ score).

Change in bone free lean body mass was assessed

时间窗: Bone free lean body mass was measured at baseline and after 12 weeks.

Bone free lean body mass (g) was measured using Dual Energy-X-ray Absorptiometry.

Change in P1NP was assessed.

时间窗: Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.

A blood draw (approximately 10 ml) was collected to investigate differences in bone formation marker (P1NP, ng/mL)

Change in CTX was assessed

时间窗: Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.

A blood draw (approximately 10 ml) was collected to investigate differences in bone resorption marker (CTX, ng/mL)

Change in menstrual history was assessed

时间窗: MH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.

A menstrual history questionnaire (MH) was used to determine if a participant was pregnant.

Change in calcium intake was assessed

时间窗: CI questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.

Daily calcium intake (mg/d) was estimated using a calcium intake questionnaire (CI).

Change in Body Mass Index (BMI) was assessed

时间窗: Height and weight were collected at baseline and after 12 weeks.

Height (cm) and weight (kg) were collected to calculate BMI (kg/m2).

次要结局

  • Change in Arterial stiffness was assessed(Arterial stiffness was collected at baseline, at 6 weeks, and after 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SoJung Kim

Assistant Professor

University of Massachusetts, Lowell

研究点 (2)

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