Clinical Effect of Massage Chair on Older Adults | NCT03732729

Studies
Clinical Effect of Massage Chair on Older Adults

NCT03732729

Sponsor

Eunju Lee

Status

Completed

Last Update Posted

Jul 28, 2020Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Older Adults

Interventions

massage chair

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 11, 2018Actual

Primary Completion Date

Apr 16, 2020Actual

Completion Date

Apr 16, 2020Actual

First Submitted Date

Nov 4, 2018

First Submission Date that Met QC Criteria

Nov 5, 2018

First Posted Date

Nov 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2020

Last Update Posted Date

Jul 28, 2020Actual

Name	Class
Bodyfriend	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Massage chair	Experimental	lifestyle modification education(once)+ Using massage chair	Device: massage chair
Control	No Intervention	lifestyle modification education(once)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
massage chair	Device	Patient should use massage chair, twice per day, for 30minutes	Massage chair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum cortisol level	Investigate serum cortisol level of baseline & 24weeks between 2 groups.	Change from baseline serum cortisol level at 24weeks

Secondary Outcomes

Measure	Description	Time Frame
Cortisol/DHEA-s ratio	Investigate serum Cortisol/DHEA-s ratio level of baseline & 24weeks between 2 groups.	Change from Baseline cortisol/DHEA-s ratio level at 24weeks
Serum Serotonin level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eunju Lee	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AsanMC		Seoul		05505	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided