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临床试验/NCT04444102
NCT04444102进行中(未招募)不适用

The Acute Impact of Yoga-based Stretching on Inflammation and Its Resolution: a Pilot Study

Harvard University Faculty of Medicine2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Feasibility of a pilot study including one session of acute stretching and serial blood samples over a period of 24 hours.

研究概览

简要总结

The goal of this study is to explore the impact of two types of yoga-based body stretching (mild and intense) on dynamic changes of Systemic Inflammatory Cytokines (SICs) and Specialized Pro-resolving Mediators (SPMs) in yoga-naïve subjects.

详细描述

During the last decade, yoga has become increasingly popular in Western cultures. The 2017 NIH report indicated that 14.3% of the adult population practice yoga in the USA. The most common yoga styles tested in randomized clinical trials (RCTs) are Hatha, Iyengar, and Patanjali.

One key physical component of yoga is the stretching that occurs during different postures. Based on animal studies, it is plausible to think that the physical intensity of stretching may affect systemic inflammatory outcomes, i.e. SICs and SPMs. However, human studies have not isolated and quantified the impact of stretching. In consequence, it is not known to what extent the benefits of yoga can be attributed to the physical aspect of stretching. One way to explore the effect of yoga would be to isolate the stretching element and compare two stretching protocols with yoga-based postures on SICs and SPMs.

In previous preclinical studies using an ex-vivo stretching model of mouse connective tissue (AICUC: 04996), the investigators found that fibroblasts are actively involved in the regulation of connective tissue tension, demonstrating that fibroblasts have a more elaborate scheme of responses to mechanical stress than was previously thought.

Later, in the inflammatory active stretch rat model (AICUC 04995), the investigators found that after 10 minutes of an active stretch there was a significant reduction in the inflammatory lesion size area measured with ultrasound and a reduction of infiltrating neutrophils. The SPM Resolvin 1 (RvD1) was also measured and showed a significant difference between the stretch and no stretch group. These promising results encouraged the investigators to keep exploring the fundamental innate mechanism by which the body enhances the healing of an inflammatory process regardless of its etiology; e.g., a mouse breast cancer model with active stretch showed that with four weeks of stretching once a day, tumors were reduced roughly to the half comparing with the no-stretch group and a pig study currently underway is exploring the effects of active stretching on SPMs production and determining changes in Polymorphonuclear Neutrophil (PMN) and macrophages migration toward the inflammatory stimulus.

These pre-clinical results motivated the research group to move forward with a translational pilot study to explore first the feasibility and second, the effect of stretching on the connective tissue and muscles of healthy humans. The investigators presume to find an effect of stretching on a systemic level. Hence, they propose to measure levels of SICs and SPMs, as well as their changes over time after one acute session of yoga-based stretching postures. The investigators plan to collect blood samples at baseline pre-intervention and then at 0 minutes, 30 minutes, 1, 2, and 3, and 24 hours after the intervention. Samples will be analyzed using flow cytometry and ELISA.

研究设计

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

盲法说明

Participants and yoga-based stretching instructor are not blinded. Nurses and lab technicians are blinded during blood draws. Laboratory analysts are blinded during sample analyses. Statisticians will be unblinded once all laboratory analyses are completed.

入排标准

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

入选标准

  • Healthy adults
  • Age between 40 - 60 years old.
  • Non-smoking
  • BMI between 19 and 29.

排除标准

  • Any history of chronic inflammatory disease or recent acute illness (< 1 month)
  • Vaccination within the last 3 months
  • Regular medication, or any medication in the preceding week
  • Practice of structured higher-intensity exercise at least twice a week for more than 30 minutes
  • Pregnancy
  • Endocrine disorders (e.g. diabetes)
  • Significant soft tissue injury
  • Surgical supportive devices (nails, wire, screws, pins, plates) in an area of the body to be stretched (toes, ankles, knees, hips, shoulders, elbows, wrists, fingers and spine)
  • Fractures in the past 3 years
  • Generalized joint hypermobility or genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome
  • Alcoholism (> 10 drinks per week) and drug abuse.

结局指标

主要结局

Feasibility of a pilot study including one session of acute stretching and serial blood samples over a period of 24 hours.

时间窗: Two consecutive study visits per participants over a period of 24 hours

* Study recruitment will be completed within 9 months * \>70% of participants will complete two study visits * Participants will adhere to study protocol, including completion of outcome assessments (\> 90%) and complying with stretching instructions specific to the mild and intense stretching protocol (confirmed with video analysis) * There will be no serious adverse events reported.

次要结局

  • Systemic inflammatory cytokines(Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.)
  • Specialized pro-resolving mediators (SPMs)(Baseline, 0-, 30-, 60-, 120-, 180-minutes and 24 hours post intervention.)

研究者

发起方
Harvard University Faculty of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Wayne

Principal Investigator

Harvard University Faculty of Medicine

研究点 (2)

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