Older Adults
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEmassage chair
Patient should use massage chair, twice per day, for 30minutes
Sponsors
Bodyfriend
Eunju Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum cortisol level | Change from baseline serum cortisol level at 24weeks | Investigate serum cortisol level of baseline & 24weeks between 2 groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Serotonin level | Change from Baseline serum serotonin level at 24weeks | Investigate serum serotonin level of baseline & 24weeks between 2 groups. |
| Serum IGF-1 level | Change from Baseline Serum IGF-1 level level at 24weeks | Investigate serum IGF-1 level of baseline & 24weeks between 2 groups. |
| ESR | Change from Baseline ESR level at 24weeks | Investigate serum ESR level of baseline & 24weeks between 2 groups. |
| hsCRP | Change from Baseline hs CRP level at 24weeks | Investigate serum hsCRP level of baseline & 24weeks between 2 groups. |
| NK cell activity | Change from Baseline NK cell activity level at 24weeks | Investigate serum NK cell activity of baseline & 24weeks between 2 groups. |
| Cortisol/DHEA-s ratio | Change from Baseline cortisol/DHEA-s ratio level at 24weeks | Investigate serum Cortisol/DHEA-s ratio level of baseline & 24weeks between 2 groups. |
| Korean version Short form Geriatric Depression Scale(SGDS-K) score | SGDS-K summed total score is changed lower at 24weeks from baseline | 15 item measure to assess the depression |
| Korean version -Brief Encounter Psychosocial Instrument(BEPSI-K) score | BEPSI-K summed total score is changed lower at 24weeks from baseline | 5 item measure to assess the Stress |
| The 5-level EQ-5D version(EQ-5D-5L) score | EQ-5D-5L summed total score is changed higher at 24weeks from baseline | 6 item measure to assess the quality of life |
| Muscle tone score | Individual site Muscle tone score is changed higher at 24weeks from baseline | 6 item measure to assess Muscle tone of both trapezoid& forearm & thigh |
| Telomere length | Change from Baseline Telomere length level at 24weeks | Investigate Telomere length of baseline & 24weeks between 2 groups |
Countries
South Korea
Outcome results
None listed