A Study for Evaluation of Massage Chair in Community-dwelling Older Adults: Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Serum cortisol level
研究概览
简要总结
The use of massage chairs is becoming more popular in many countries. According to the previous reports, some manual massages have positive effects on the mood, pain, fatigue, and sleep quality. However, the clinical benefits of the massage chair have not been fully understood. In this trial, it is aimed to evaluate the clinical effectiveness of the 6-month regular use of massage chair twice a day. It is hypothesized that long-term regular use of massage chair has positive effects on the hormonal level related to the stress, inflammation, and aging, as well as physical, psychologic, and muscle quality.
详细描述
A total of enrolled 80 patients after randomization(1:1) in intervention(Massage chair)group and Control groups, will be provided
-
Massage chair group
-
lifestyle modification education + using massage chair twice per day during 24weeks
-
control group: only lifestyle modification education
- Screening visit
- collection demographic data, BMD, vital sign, Medication history
- Visit 1 (0-week)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling healthy adults between 50-75 years old
排除标准
- •Unable to sign his/her own informed consent
- •Any disability or damages in 4 extremity.
- •Who have exercised regularly more than twice a week during the last 24 weeks
- •Who have received regular massage during the last 24 weeks
- •Confirmed osteoporosis of T score <-2.5 from BMD or history of compression fracture
- •Cortisol-metabolism disorders or other diseases that can affect steroid secretion
- •Who have taken any medication related with steroid secretion or metabolism within 2 weeks
- •Expected life expectancy less than 12 months (Symptomatic heart failure, end-stage renal failure)
- •Spouse is already enrolled in this research
结局指标
主要结局
Serum cortisol level
时间窗: Change from baseline serum cortisol level at 24weeks
Investigate serum cortisol level of baseline \& 24weeks between 2 groups.
次要结局
- Cortisol/DHEA-s ratio(Change from Baseline cortisol/DHEA-s ratio level at 24weeks)
- Serum Serotonin level(Change from Baseline serum serotonin level at 24weeks)
- hsCRP(Change from Baseline hs CRP level at 24weeks)
- Korean version Short form Geriatric Depression Scale(SGDS-K) score(SGDS-K summed total score is changed lower at 24weeks from baseline)
- Telomere length(Change from Baseline Telomere length level at 24weeks)
- The 5-level EQ-5D version(EQ-5D-5L) score(EQ-5D-5L summed total score is changed higher at 24weeks from baseline)
- Serum IGF-1 level(Change from Baseline Serum IGF-1 level level at 24weeks)
- NK cell activity(Change from Baseline NK cell activity level at 24weeks)
- Muscle tone score(Individual site Muscle tone score is changed higher at 24weeks from baseline)
- ESR(Change from Baseline ESR level at 24weeks)
- Korean version -Brief Encounter Psychosocial Instrument(BEPSI-K) score(BEPSI-K summed total score is changed lower at 24weeks from baseline)
研究者
Eunju Lee
associate professor
Asan Medical Center