Clinical Effect of Massage Chair on Older Adults

Study Overview
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Brief Summary
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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
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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) Vital sign Charlson comorbidity index Laboratory test WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L Physical& muscular assessment SPPB, Grip strength, Muscle tone, Bioimpedance analysis Visit 2-6 (4,8,12,16 weeks) via Phone contact: assess compliance and adverse events visit 7 (24weeks) Vital sign Laboratory test WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L Physical& muscular assessment SPPB, Grip strength, Muscle tone, Bioimpedance analysis Compliance Adverse events

Official Title
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A Study for Evaluation of Massage Chair in Community-dwelling Older Adults: Randomized Study

Conditions
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Older Adults

Intervention / Treatment
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* Device: massage chair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling healthy adults between 50-75 years old Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage chair<br>lifestyle modification education(once)+ Using massage chair | Device: massage chair<br>* Patient should use massage chair, twice per day, for 30minutes<br>|
| No Intervention: Control<br>lifestyle modification education(once) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cortisol level | Investigate serum cortisol level of baseline & 24weeks between 2 groups. | Change from baseline serum cortisol level at 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol/DHEA-s ratio | Investigate serum Cortisol/DHEA-s ratio level of baseline & 24weeks between 2 groups. | Change from Baseline cortisol/DHEA-s ratio level at 24weeks | 
| Serum Serotonin level | Investigate serum serotonin level of baseline & 24weeks between 2 groups. | Change from Baseline serum serotonin level at 24weeks | 
| Serum IGF-1 level | Investigate serum IGF-1 level of baseline & 24weeks between 2 groups. | Change from Baseline Serum IGF-1 level level at 24weeks | 
| ESR | Investigate serum ESR level of baseline & 24weeks between 2 groups. | Change from Baseline ESR level at 24weeks | 
| hsCRP | Investigate serum hsCRP level of baseline & 24weeks between 2 groups. | Change from Baseline hs CRP level at 24weeks | 
| NK cell activity | Investigate serum NK cell activity of baseline & 24weeks between 2 groups. | Change from Baseline NK cell activity level at 24weeks | 
| Telomere length | Investigate Telomere length of baseline & 24weeks between 2 groups | Change from Baseline Telomere length level at 24weeks | 
| Korean version Short form Geriatric Depression Scale(SGDS-K) score | 15 item measure to assess the depression | SGDS-K summed total score is changed lower at 24weeks from baseline | 
| Korean version -Brief Encounter Psychosocial Instrument(BEPSI-K) score | 5 item measure to assess the Stress | BEPSI-K summed total score is changed lower at 24weeks from baseline | 
| The 5-level EQ-5D version(EQ-5D-5L) score | 6 item measure to assess the quality of life | EQ-5D-5L summed total score is changed higher at 24weeks from baseline | 
| Muscle tone score | 6 item measure to assess Muscle tone of both trapezoid& forearm & thigh | Individual site Muscle tone score is changed higher at 24weeks from baseline |