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Clinical Effect of Massage Chair on Older Adults (SEAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732729
Recruitment Status : Completed
First Posted : November 7, 2018
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
Bodyfriend
Information provided by (Responsible Party):
Eunju Lee, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Older Adults Device: massage chair Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Study for Evaluation of Massage Chair in Community-dwelling Older Adults: Randomized Study
Actual Study Start Date : December 11, 2018
Actual Primary Completion Date : April 16, 2020
Actual Study Completion Date : April 16, 2020

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)



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732729


Locations
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Korea, Republic of
AsanMC
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Eunju Lee
Bodyfriend
Investigators
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Principal Investigator: Eunju Lee Asan Medical Center
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Responsible Party: Eunju Lee, associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03732729    
Other Study ID Numbers: 2018-1204
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No