Clinical Effect of Massage Chair on Older Adults

Older Adults Clinical Trial

— SEAT  

Official title:

A Study for Evaluation of Massage Chair in Community-dwelling Older Adults: Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732729
• Other study ID #: 2018-1204
• Status: Completed
• Phase: N/A
• Start date: December 11, 2018
• Est. completion date: April 16, 2020

Study information

• Verified date: July 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Older Adults

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	AsanMC	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Eunju Lee	Bodyfriend

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum cortisol level	Investigate serum cortisol level of baseline & 24weeks between 2 groups.	Change from baseline serum cortisol level at 24weeks
Secondary	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
Secondary	Serum Serotonin level	Investigate serum serotonin level of baseline & 24weeks between 2 groups.	Change from Baseline serum serotonin level at 24weeks
Secondary	Serum IGF-1 level	Investigate serum IGF-1 level of baseline & 24weeks between 2 groups.	Change from Baseline Serum IGF-1 level level at 24weeks
Secondary	ESR	Investigate serum ESR level of baseline & 24weeks between 2 groups.	Change from Baseline ESR level at 24weeks
Secondary	hsCRP	Investigate serum hsCRP level of baseline & 24weeks between 2 groups.	Change from Baseline hs CRP level at 24weeks
Secondary	NK cell activity	Investigate serum NK cell activity of baseline & 24weeks between 2 groups.	Change from Baseline NK cell activity level at 24weeks
Secondary	Telomere length	Investigate Telomere length of baseline & 24weeks between 2 groups	Change from Baseline Telomere length level at 24weeks
Secondary	Korean version Short form Geriatric Depression Scale(SGDS-K) score	15 item measure to assess the depression	SGDS-K summed total score is changed lower at 24weeks from baseline
Secondary	Korean version -Brief Encounter Psychosocial Instrument(BEPSI-K) score	5 item measure to assess the Stress	BEPSI-K summed total score is changed lower at 24weeks from baseline
Secondary	The 5-level EQ-5D version(EQ-5D-5L) score	6 item measure to assess the quality of life	EQ-5D-5L summed total score is changed higher at 24weeks from baseline
Secondary	Muscle tone score	6 item measure to assess Muscle tone of both trapezoid& forearm & thigh	Individual site Muscle tone score is changed higher at 24weeks from baseline