Clinical Effect of Massage Chair on Older Adults (SEAT)

July 25, 2020 updated by: Eunju Lee

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum cortisol level
Time Frame: Change from baseline serum cortisol level at 24weeks
Investigate serum cortisol level of baseline & 24weeks between 2 groups.
Change from baseline serum cortisol level at 24weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cortisol/DHEA-s ratio
Time Frame: Change from Baseline cortisol/DHEA-s ratio level at 24weeks
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
Time Frame: Change from Baseline serum serotonin level at 24weeks
Investigate serum serotonin level of baseline & 24weeks between 2 groups.
Change from Baseline serum serotonin level at 24weeks
Serum IGF-1 level
Time Frame: Change from Baseline Serum IGF-1 level level at 24weeks
Investigate serum IGF-1 level of baseline & 24weeks between 2 groups.
Change from Baseline Serum IGF-1 level level at 24weeks
ESR
Time Frame: Change from Baseline ESR level at 24weeks
Investigate serum ESR level of baseline & 24weeks between 2 groups.
Change from Baseline ESR level at 24weeks
hsCRP
Time Frame: Change from Baseline hs CRP level at 24weeks
Investigate serum hsCRP level of baseline & 24weeks between 2 groups.
Change from Baseline hs CRP level at 24weeks
NK cell activity
Time Frame: Change from Baseline NK cell activity level at 24weeks
Investigate serum NK cell activity of baseline & 24weeks between 2 groups.
Change from Baseline NK cell activity level at 24weeks
Telomere length
Time Frame: Change from Baseline Telomere length level at 24weeks
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
Time Frame: SGDS-K summed total score is changed lower at 24weeks from baseline
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
Time Frame: BEPSI-K summed total score is changed lower at 24weeks from baseline
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
Time Frame: EQ-5D-5L summed total score is changed higher at 24weeks from baseline
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
Time Frame: Individual site Muscle tone score is changed higher at 24weeks from baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eunju Lee

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bodyfriend

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eunju Lee, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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