Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2018-12-11
2020-04-16
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Massage chair
lifestyle modification education(once)+ Using massage chair
massage chair
Patient should use massage chair, twice per day, for 30minutes
Control
lifestyle modification education(once)
No interventions assigned to this group
Interventions
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massage chair
Patient should use massage chair, twice per day, for 30minutes
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
50 Years
75 Years
ALL
Yes
Sponsors
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Bodyfriend
UNKNOWN
Eunju Lee
OTHER
Responsible Party
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Eunju Lee
associate professor
Principal Investigators
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Eunju Lee
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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AsanMC
Seoul, , South Korea
Countries
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Other Identifiers
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2018-1204
Identifier Type: -
Identifier Source: org_study_id
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