Clinical Effect of Massage Chair on Older Adults
关键词
抽象
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
1. Screening visit
- collection demographic data, BMD, vital sign, Medication history
2. Visit 1 (0-week)
1. Vital sign
2. Charlson comorbidity index
3. Laboratory test
- WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length
4. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L
5. Physical& muscular assessment
- SPPB, Grip strength, Muscle tone, Bioimpedance analysis
3. Visit 2-6 (4,8,12,16 weeks) via Phone contact: assess compliance and adverse events
4. visit 7 (24weeks)
1. Vital sign
2. Laboratory test
- WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length
3. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L
4. Physical& muscular assessment
- SPPB, Grip strength, Muscle tone, Bioimpedance analysis
5. Compliance
6. Adverse events
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 11/03/2018 |
| 提交的预估入学人数: | 11/04/2018 |
| 首次发布: | 11/06/2018 |
| 上次提交的更新: | 07/24/2020 |
| 最近更新发布: | 07/27/2020 |
| 实际学习开始日期: | 12/10/2018 |
| 预计主要完成日期: | 04/15/2020 |
| 预计完成日期: | 04/15/2020 |
状况或疾病
干预/治疗
Device: Massage chair
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Massage chair lifestyle modification education(once)+ Using massage chair | Device: Massage chair Patient should use massage chair, twice per day, for 30minutes |
| No Intervention: Control lifestyle modification education(once) |
资格标准
| 有资格学习的年龄 | 50 Years 至 50 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Community-dwelling healthy adults between 50-75 years old Exclusion Criteria: 1. Unable to sign his/her own informed consent 2. Any disability or damages in 4 extremity. 3. Who have exercised regularly more than twice a week during the last 24 weeks 4. Who have received regular massage during the last 24 weeks 5. Confirmed osteoporosis of T score <-2.5 from BMD or history of compression fracture 6. Cortisol-metabolism disorders or other diseases that can affect steroid secretion 7. Who have taken any medication related with steroid secretion or metabolism within 2 weeks 8. Expected life expectancy less than 12 months (Symptomatic heart failure, end-stage renal failure) 9. Spouse is already enrolled in this research |
结果
主要结果指标
1. Serum cortisol level [Change from baseline serum cortisol level at 24weeks]
次要成果指标
1. Cortisol/DHEA-s ratio [Change from Baseline cortisol/DHEA-s ratio level at 24weeks]
2. Serum Serotonin level [Change from Baseline serum serotonin level at 24weeks]
3. Serum IGF-1 level [Change from Baseline Serum IGF-1 level level at 24weeks]
4. ESR [Change from Baseline ESR level at 24weeks]
5. hsCRP [Change from Baseline hs CRP level at 24weeks]
6. NK cell activity [Change from Baseline NK cell activity level at 24weeks]
7. Telomere length [Change from Baseline Telomere length level at 24weeks]
8. Korean version Short form Geriatric Depression Scale(SGDS-K) score [SGDS-K summed total score is changed lower at 24weeks from baseline]
9. Korean version -Brief Encounter Psychosocial Instrument(BEPSI-K) score [BEPSI-K summed total score is changed lower at 24weeks from baseline]
10. The 5-level EQ-5D version(EQ-5D-5L) score [EQ-5D-5L summed total score is changed higher at 24weeks from baseline]
11. Muscle tone score [Individual site Muscle tone score is changed higher at 24weeks from baseline]
