Clinical Effect of Massage Chair on Older Adults

NCT ID: NCT03732729

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-11

Study Completion Date

2020-04-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Older Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Massage chair

lifestyle modification education(once)+ Using massage chair

Group Type EXPERIMENTAL

massage chair

Intervention Type DEVICE

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

Control

lifestyle modification education(once)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

massage chair

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bodyfriend

UNKNOWN

Sponsor Role collaborator

Eunju Lee

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eunju Lee

associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eunju Lee

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AsanMC

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-1204

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Qigong Exercise and Sleep Quality
NCT06532864 COMPLETED NA