Skip to main content
OpenTrials
Completed

NCT Number: NCT03732729

Clinical Effect of Massage Chair on Older Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Older Adults

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AsanMC

Seoul, 05505, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage chair

Device

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

Primary outcomes

  1. Serum cortisol level

    Time frame: Change from baseline serum cortisol level at 24weeks

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

Secondary outcomes

  1. 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.

  2. Serum Serotonin level

    Time frame: Change from Baseline serum serotonin level at 24weeks

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

  3. 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.

  4. ESR

    Time frame: Change from Baseline ESR level at 24weeks

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

  5. hsCRP

    Time frame: Change from Baseline hs CRP level at 24weeks

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

  6. 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.

  7. Telomere length

    Time frame: Change from Baseline Telomere length level at 24weeks

    Investigate Telomere length of baseline & 24weeks between 2 groups

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Eunju Lee

Other

Collaborators

  • Bodyfriend

Registry information

Official study title

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

Acronym: SEAT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2018
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.