Tai Chi Intervention for Geriatric Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 266
- 主要终点
- Pain severity
研究概览
简要总结
Accumulating evidence supports that more pain, whether measured by number of pain sites or pain severity, is associated with poorer cognitive function and mobility, and fall risk in older persons. Tai Chi which holistically integrates physical and cognitive functions offers the possibility not only of alleviating pain but also improving attention and mobility in the many older adults who have chronic multisite pain. This proposed full-size randomized controlled Tai Chi trial is a direct extension of the investigators' previous work examining chronic pain, attention demands, mobility and falls in the older population, and is built on the investigators' National Institute on Aging-supported Tai Chi feasibility and acceptability pilot studies among older adults with multisite pain and risk for falls. The goal of this single-blinded randomized controlled trial is to examine the effects of a 24-week Tai Chi intervention on chronic pain, cognition, mobility, fear of falling, and fall rate in older adults with multisite pain and at risk for falls. The results of this study will provide a foundation to establish the clinical significance of Tai Chi in the management of chronic multisite pain and to explore the mechanisms through which Tai Chi improves chronic pain symptoms and lowers fall rate in at-risk older adults.
详细描述
The investigators will measure pain severity, pain interference, and fear of falling at baseline, mid-point (3-month), and post-intervention (6-month), as well as rate of falls during the intervention (0- to 6-month) and the 6-month follow-up period (month 6 to month 12) in 266 older adults (Tai Chi: N=133, and light physical exercise control: N=133). In addition, they will measure pain-related biomarkers, cognition, single-task and dual-task gait function, free-living physical activity, and sleep at baseline and post-intervention. The primary aims are: 1. to examine the effects of Tai Chi on pain symptoms in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have less pain, measured as pain severity and interference, than those in the light physical exercise control group; 2. to examine the effects of Tai Chi on fear of falling and rate of falls in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have less fear of falling and fewer falls than those in the light physical exercise control group. The secondary/exploratory aims are: 3. to examine the effects of Tai Chi on pain-related biomarkers in older adults with multisite pain. It is hypothesized that Tai Chi intervention will have greater reductions in levels of pain-related biomarkers and and beta endorphin, than those in the light physical exercise control group; 4. to examine the roles of changes in pain symptoms in the change of fall rate by Tai Chi in older adults with multisite pain. It is hypothesized that the effect of Tai Chi on the reduced fall rate will be explained in part by improvements in pain symptoms in older adults with multisite pain; 5. to examine the roles of changes in cognition and cognitive motor function in the change of fall rate by Tai Chi in older adults with multisite pain. It is hypothesized that the reduced fall rate in the Tai Chi group will be mediated by changes in cognition and cognitive-motor function in older adults with multisite pain.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 65 years or older
- •report chronic multisite (≥2 sites) musculoskeletal pain
- •have had 1 or more falls in the past year or current use of an assistive device (a cane or walker)
- •be able to walk 20 feet without help
- •be able to communicate in English
排除标准
- •actively engage in moderate to vigorous exercise for more than 40 min/week
- •practiced Tai Chi or other mind-body exercise within the past year, or practiced Tai Chi or other mind-body exercise regularly for at least 3 months within the past 5 years
- •have cognitive impairment consistent with dementia (Montreal Cognitive Assessment (MOCA) score < 18 after corrections),
- •have a diagnosis of a disease/condition that would interfere with their study participation (e.g., rheumatoid arthritis, stroke, Parkinson's disease, degenerative neuromuscular disease, unstable cardiac disease, Alzheimer's disease or other dementia, terminal disease)
研究组 & 干预措施
Tai Chi
Tai Chi walking drills and Yang-style Tai Chi 8 forms.
干预措施: Tai Chi (Behavioral)
Light physical exercise
Usual-pace walking, strength exercise, stretching exercise, and balance exercise.
干预措施: Light physical exercise (Behavioral)
结局指标
主要结局
Pain severity
时间窗: 24 weeks
Pain severity will be assessed using the Brief Pain Inventory.
Pain interference
时间窗: 24 weeks
Pain interference will be assessed using the Brief Pain Inventory.
Rate of falls
时间窗: 48 weeks
Rate of falls will be assessed using monthly falls calendar postcards.
Fear of falling
时间窗: 24 weeks
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
Pain severity
时间窗: 6 months
Pain severity will be assessed using the Brief Pain Inventory.
Pain interference
时间窗: 6 months
Pain interference will be assessed using the Brief Pain Inventory.
Fear of falling
时间窗: 6 months
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
Rate of falls
时间窗: 12 months
Rate of falls will be assessed using monthly falls calendar postcards.
次要结局
- Interleukin 6(24 weeks)
- C-reactive protein(24 weeks)
- Tumor necrosis factor alpha(24 weeks)
- Beta endorphin(24 weeks)
- Attention(24 weeks)
- Executive function(24 weeks)
- Single-task stride time(24 weeks)
- Single-task swing time(24 weeks)
- Nuclear factor kappa B(24 weeks)
- Single-task stride length(24 weeks)
- Dual-task stride time(24 weeks)
- Dual-task stride length(24 weeks)
- Free-living physical activity(24 weeks)
- Dual-task swing time(24 weeks)
- Sleep time(24 weeks)
- Sleep efficiency(24 weeks)
- C-reactive protein(6 months)
- Interleukin 6(6 months)
- Tumor necrosis factor alpha(6 months)
- Nuclear factor kappa B(6 months)
- Beta endorphin(6 months)
- Attention(6 months)
- Executive function(6 months)
- Single-task stride time(6 months)
- Single-task stride length(6 months)
- Single-task swing time(6 months)
- Dual-task stride time(6 months)
- Dual-task stride length(6 months)
- Dual-task swing time(6 months)
- Free-living physical activity(6 months)
- Sleep time(6 months)
- Sleep efficiency(6 months)
研究者
Tongjian You
Professor
University of Massachusetts, Boston