Clinical Effect of Massage Chair on Older Adults (SEAT)

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

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.

Study Overview

• Status: Completed
• Conditions: Older Adults
• Intervention / Treatment: Device: massage chair

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • AsanMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eunju Lee
• Collaborators: Bodyfriend
• Investigators: Principal Investigator: Eunju Lee, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): April 16, 2020
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: November 4, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 25, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018-1204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No