Can Yoga Decrease Pain and Inflammation Among Women Aged 60 or Older: A Pilot Feasibility Study
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change from baseline in inflammatory markers
概览
简要总结
The Restorative Flow Yoga Study is a pilot project looking at whether restorative flow yoga will reduce inflammation and pain in women 60 and older who experience chronic pain.
详细描述
The aims of the study are to (1) evaluate the feasibility of implementing a restorative-flow yoga randomized trial (24 classes, held twice per week) for women aged 60 or older who experience chronic pain; and (2) evaluate the preliminary efficacy of restorative-flow yoga to decrease pain and inflammation among women aged 60 or older. Feasibility measures will include three areas of focus (a) acceptability, (b) implementation, and (c) demand and use, evaluated using recruitment rate, retention rate, class and home practice adherence rates, resource utilization, and safety. With a sample size of 40, this pilot feasibility study is likely under-powered to determine intervention effects. However, the study will evaluate preliminary efficacy of the yoga intervention. The study will measure BMI, blood pressure, resting heart rate, physical function measures, and inflammatory markers C-reactive protein, IL-2, IL-1β, TNF-α, IL-6, IL-4, and IL-10) at baseline and outcome assessments (after 24 class sequence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization to arm follows the baseline assessment visit.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 60 or older
- •Report AVERAGE severity of 3 or higher on the brief pain inventory
- •Blood pressure is less than 160/100 mm Hg
- •Heart rate is between 55-110 bpm
- •Able and willing to obtain physician's approval to participate
排除标准
- •Currently practicing yoga two or more times per week
- •Cognitively impaired
结局指标
主要结局
Change from baseline in inflammatory markers
时间窗: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline measures of C-reactive protein, IL-2, IL-1β, TNF-α, IL-6, IL-4, and IL-10
Change from baseline in Average Pain on The Brief Pain Inventory
时间窗: Baseline and outcome (after 24 class sequence, about 14 weeks)
Change from baseline self-report of AVERAGE pain on the severity scale of the The Brief Pain Inventory (BPI) where where 0=no pain and 10=pain as bad as you can imagine. The BPI is a widely used measurement tool for assessing clinical pain.
次要结局
- Change from baseline in the 'Arm Curl Test'(Baseline and outcome (after 24 class sequence, about 14 weeks))
- Change from baseline in the 'Chair Sit-and-Reach Test'(Baseline and outcome (after 24 class sequence, about 14 weeks))
- Change from baseline in the 'Back Scratch Test'(Baseline and outcome (after 24 class sequence, about 14 weeks))
- Change from baseline in the '8-foot up and go'(Baseline and outcome (after 24 class sequence, about 14 weeks))
- Change from baseline in the 'Chair Stand Test'(Baseline and outcome (after 24 class sequence, about 14 weeks))
- Change from baseline in the '2-Minute Step Test'(Baseline and outcome (after 24 class sequence, about 14 weeks))