NCT03732729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 11, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

November 4, 2018

Last Update Submit

July 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum cortisol level

    Investigate serum cortisol level of baseline \& 24weeks between 2 groups.

    Change from baseline serum cortisol level at 24weeks

Secondary Outcomes (11)

  • Cortisol/DHEA-s ratio

    Change from Baseline cortisol/DHEA-s ratio level at 24weeks

  • Serum Serotonin level

    Change from Baseline serum serotonin level at 24weeks

  • Serum IGF-1 level

    Change from Baseline Serum IGF-1 level level at 24weeks

  • ESR

    Change from Baseline ESR level at 24weeks

  • hsCRP

    Change from Baseline hs CRP level at 24weeks

  • +6 more secondary outcomes

Study Arms (2)

Massage chair

EXPERIMENTAL

lifestyle modification education(once)+ Using massage chair

Device: massage chair

Control

NO INTERVENTION

lifestyle modification education(once)

Interventions

Patient should use massage chair, twice per day, for 30minutes

Massage chair

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling healthy adults between 50-75 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AsanMC

Seoul, 05505, South Korea

Location

Study Officials

  • Eunju Lee

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 7, 2018

Study Start

December 11, 2018

Primary Completion

April 16, 2020

Study Completion

April 16, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations