Clinical trial NCT03732729: Clinical Effect of Massage Chair on Older Adults
Official title: A Study for Evaluation of Massage Chair in Community-dwelling Older Adults: Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Bodyfriend
First posted: 2018-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Eligibility 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

Primary outcomes:
measure: Serum cortisol level
timeFrame: Change from baseline serum cortisol level at 24weeks
Secondary outcomes:
measure: Cortisol/DHEA-s ratio
timeFrame: Change from Baseline cortisol/DHEA-s ratio level at 24weeks
measure: Serum Serotonin level
timeFrame: Change from Baseline serum serotonin level at 24weeks
measure: Serum IGF-1 level
timeFrame: Change from Baseline Serum IGF-1 level level at 24weeks
measure: ESR
timeFrame: Change from Baseline ESR level at 24weeks
measure: hsCRP
timeFrame: Change from Baseline hs CRP level at 24weeks
measure: NK cell activity
timeFrame: Change from Baseline NK cell activity level at 24weeks
measure: Telomere length
timeFrame: Change from Baseline Telomere length level at 24weeks
measure: Korean version Short form Geriatric Depression Scale(SGDS-K) score
timeFrame: SGDS-K summed total score is changed lower at 24weeks from baseline
measure: Korean version -Brief Encounter Psychosocial Instrument(BEPSI-K) score
timeFrame: BEPSI-K summed total score is changed lower at 24weeks from baseline
measure: The 5-level EQ-5D version(EQ-5D-5L) score
timeFrame: EQ-5D-5L summed total score is changed higher at 24weeks from baseline
measure: Muscle tone score
timeFrame: Individual site Muscle tone score is changed higher at 24weeks from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: AsanMC
Study officials:
affiliation: Asan Medical Center
name: Eunju Lee
role: PRINCIPAL_INVESTIGATOR
References: