AzTrials
AzTrials

Older AdultsSEATNCT03732729

Clinical Effect of Massage Chair on Older Adults

A study testing massage chair in people with Older Adults, run by Eunju Lee at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Older Adults
What is being tested?
massage chair
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Korea
Study dates
11 Dec 2018to 16 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • AsanMC

    Seoul, 05505

Other trials in South Korea

About this study

Official title: 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.

Read the 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
  1. Visit 1 (0-week)
  2. Vital sign
  3. Charlson comorbidity index
  4. Laboratory test
  • WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length
  1. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L
  2. Physical\& muscular assessment
  • SPPB, Grip strength, Muscle tone, Bioimpedance analysis
  1. Visit 2-6 (4,8,12,16 weeks) via Phone contact: assess compliance and adverse events
  2. visit 7 (24weeks)
  3. Vital sign
  4. Laboratory test
  • WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length
  1. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L
  2. Physical\& muscular assessment
  • SPPB, Grip strength, Muscle tone, Bioimpedance analysis
  1. Compliance
  2. Adverse events
Conditions
Older Adults
Being tested
massage chair

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • massage chairDevice

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

Study groups in NCT03732729
Study groupRoleWhat they receive
Massage chairExperimentallifestyle modification education(once)+ Using massage chair
Receives: Device: massage chair
ControlNo interventionlifestyle modification education(once)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum cortisol level

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

    Measured: Change from baseline serum cortisol level at 24weeks

Secondary outcomes (11)

  1. Cortisol/DHEA-s ratio

    Investigate serum Cortisol/DHEA-s ratio level of baseline \& 24weeks between 2 groups.

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

  2. Serum Serotonin level

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

    Measured: Change from Baseline serum serotonin level at 24weeks

  3. Serum IGF-1 level

    Investigate serum IGF-1 level of baseline \& 24weeks between 2 groups.

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

  4. ESR

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

    Measured: Change from Baseline ESR level at 24weeks

  5. hsCRP

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

    Measured: Change from Baseline hs CRP level at 24weeks

  6. NK cell activity

    Investigate serum NK cell activity of baseline \& 24weeks between 2 groups.

    Measured: Change from Baseline NK cell activity level at 24weeks

  7. Telomere length

    Investigate Telomere length of baseline \& 24weeks between 2 groups

    Measured: Change from Baseline Telomere length level at 24weeks

  8. Korean version Short form Geriatric Depression Scale(SGDS-K) score

    15 item measure to assess the depression

    Measured: SGDS-K summed total score is changed lower at 24weeks from baseline

  9. Korean version -Brief Encounter Psychosocial Instrument(BEPSI-K) score

    5 item measure to assess the Stress

    Measured: BEPSI-K summed total score is changed lower at 24weeks from baseline

  10. The 5-level EQ-5D version(EQ-5D-5L) score

    6 item measure to assess the quality of life

    Measured: EQ-5D-5L summed total score is changed higher at 24weeks from baseline

  11. Muscle tone score

    6 item measure to assess Muscle tone of both trapezoid\& forearm \& thigh

    Measured: Individual site Muscle tone score is changed higher at 24weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start11 Dec 2018
  3. Primary completion16 Apr 2020
  4. Study completion16 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732729
Sponsor's protocol ID
2018-1204
Acronym
SEAT
Status last verified
Jul 2020
First submitted
4 Nov 2018
Last updated
28 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing massage chair in people with Older Adults, run by Eunju Lee at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum cortisol level (time frame: Change from baseline serum cortisol level at 24weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03732729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in