Clinical Effect of Massage Chair on Older Adults (SEAT)

Eunju Lee

Status: Completed

Conditions: Older Adults

Treatments: Device: massage chair

Study type: Interventional

Funder types: Other

Identifiers

NCT03732729

2018-1204

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Massage chair

Experimental group

Description:

lifestyle modification education(once)+ Using massage chair

Treatment:

Device: massage chair

Control

No Intervention group

Description:

lifestyle modification education(once)