SEAT: Clinical Effect of Massage Chair on Older Adults

• Sponsor: Eunju Lee (Other)
• Overall Status: Completed
• CT.gov ID: NCT03732729
• Collaborator: Bodyfriend (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.2
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Older Adults	Device: massage chair	N/A

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

1. Visit 1 (0-week)

2. Vital sign

3. Charlson comorbidity index

4. Laboratory test

• WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length

1. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L

2. Physical& muscular assessment

• SPPB, Grip strength, Muscle tone, Bioimpedance analysis

1. Visit 2-6 (4,8,12,16 weeks) via Phone contact: assess compliance and adverse events

2. visit 7 (24weeks)

3. Vital sign

4. Laboratory test

• WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol, serotonin, DHEA-s, IGF-1, NK cell, Telomere length

1. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L

2. Physical& muscular assessment

• SPPB, Grip strength, Muscle tone, Bioimpedance analysis

1. Compliance

2. Adverse events

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Study for Evaluation of Massage Chair in Community-dwelling Older Adults: Randomized Study
• Actual Study Start Date: Dec 11, 2018
• Actual Primary Completion Date: Apr 16, 2020
• Actual Study Completion Date: Apr 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Massage chair lifestyle modification education(once)+ Using massage chair	Device: massage chair; Patient should use massage chair, twice per day, for 30minutes
No Intervention: Control lifestyle modification education(once)

Outcome Measures

Primary Outcome Measures

1. Serum cortisol level [Change from baseline serum cortisol level at 24weeks]

   Investigate serum cortisol level of baseline & 24weeks between 2 groups.

Secondary Outcome Measures

1. Cortisol/DHEA-s ratio [Change from Baseline cortisol/DHEA-s ratio level at 24weeks]

   Investigate serum Cortisol/DHEA-s ratio level of baseline & 24weeks between 2 groups.

2. Serum Serotonin level [Change from Baseline serum serotonin level at 24weeks]

   Investigate serum serotonin level of baseline & 24weeks between 2 groups.

3. Serum IGF-1 level [Change from Baseline Serum IGF-1 level level at 24weeks]

   Investigate serum IGF-1 level of baseline & 24weeks between 2 groups.

4. ESR [Change from Baseline ESR level at 24weeks]

   Investigate serum ESR level of baseline & 24weeks between 2 groups.

5. hsCRP [Change from Baseline hs CRP level at 24weeks]

   Investigate serum hsCRP level of baseline & 24weeks between 2 groups.

6. NK cell activity [Change from Baseline NK cell activity level at 24weeks]

   Investigate serum NK cell activity of baseline & 24weeks between 2 groups.

7. Telomere length [Change from Baseline Telomere length level at 24weeks]

   Investigate Telomere length of baseline & 24weeks between 2 groups

8. Korean version Short form Geriatric Depression Scale(SGDS-K) score [SGDS-K summed total score is changed lower at 24weeks from baseline]

   15 item measure to assess the depression

9. Korean version -Brief Encounter Psychosocial Instrument(BEPSI-K) score [BEPSI-K summed total score is changed lower at 24weeks from baseline]

   5 item measure to assess the Stress

10. The 5-level EQ-5D version(EQ-5D-5L) score [EQ-5D-5L summed total score is changed higher at 24weeks from baseline]

    6 item measure to assess the quality of life

11. Muscle tone score [Individual site Muscle tone score is changed higher at 24weeks from baseline]

    6 item measure to assess Muscle tone of both trapezoid& forearm & thigh

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AsanMC	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

• Eunju Lee
• Bodyfriend

Investigators

• Principal Investigator: Eunju Lee, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eunju Lee, associate professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03732729
• Other Study ID Numbers: 2018-1204
• First Posted: Nov 7, 2018
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 28, 2020