- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07529678
Differences in Autonomic Recovery Between Physically Active and Inactive Women Following an Automated Massage Chair Intervention
The Effect of Automated Electronic Massage Chair on the Autonomic Nervous System of Female University Student-Athletes and Non- Athletes
The goal of this study is to investigate whether an automated massage chair can improve the body's recovery system in healthy young women (aged 19-26 years) who are either physically active or inactive.
The main questions it aims to answer are:
- Does a single session in an automated massage chair improve heart rate variability (HRV) as an indicator of stress, relaxation, and recovery balance?
- Do individuals who are more physically active recover better after using a massage chair compared to those who are inactive?
Researchers will compare the physically active group to the physically inactive group to see if baseline physical activity levels influence the short-term recovery effects of the massage at different time points.
Participants will:
- Complete a standardized 20-minute automated massage chair session using a preset program at a self-selected moderate intensity.
- Have their heart rate data collected at baseline, prior to the massage session.
- Undergo follow-up heart rate data collection at 24, 48, and 72 hours after the session to monitor short-term recovery changes.
Study Overview
Status
Intervention / Treatment
Detailed Description
Background and Rationale Massage therapy is widely utilized to promote overall health, alleviate stress, and facilitate recovery following physical exertion. A primary mechanism through which massage aids recovery is by modulating the autonomic nervous system (ANS). The ANS consists of the sympathetic nervous system (SNS), which drives the "fight-or-flight" stress response, and the parasympathetic nervous system (PNS), which governs "rest-and-digest" processes vital for tissue repair and cardiovascular recovery.In recent years, automated electric massage chairs (AEMCs) have surged in popularity as an accessible means to replicate therapist-delivered manual massage. Despite their widespread commercial use for health and wellness, research examining their physiological impacts-particularly on autonomic regulation-remains limited. Furthermore, while physically active individuals typically demonstrate greater autonomic flexibility and faster physiological recovery than inactive individuals, it is largely unknown if these baseline physical activity levels influence the body's acute response to an automated massage intervention.
Study Objective This study aims to evaluate the acute physiological effects of a single AEMC session on autonomic regulation among healthy female university students. By utilizing heart rate variability (HRV) as a non-invasive marker of sympathovagal balance, researchers will compare the physiological responses of physically active participants against those of inactive participants over a 72-hour recovery period.
Study Procedures Participants will be assigned to one of two groups based on their habitual physical activity levels: a physically active group (engaging in at least three supervised training sessions per week) and an inactive group (identified via the International Physical Activity Questionnaire as having low physical activity levels).
The study involves the following procedural sequence:
- Familiarization: Prior to the initial assessment, participants will complete a familiarization session to acclimate to the monitoring devices and the AEMC while it is both powered off and on.
- Baseline Assessment: On the experimental day, participants will be fitted with a wrist-worn heart rate monitor and a chest strap heart rate transmitter. Participants will sit in the powered-off AEMC for five minutes to capture baseline HRV data. During this time, they will be instructed to remain relaxed and minimize both body movements and communication.
- Intervention: Participants will be positioned in a reclined posture, with their upper bodies supported and legs and feet elevated to heart level. They will then undergo a 20-minute standardized "Recharge" program on the AEMC. This program delivers a continuous, moderate-intensity massage using kneading and rolling techniques focused on the back, neck, shoulders, forearms, and thighs. The intensity will be subjectively selected by the participant to a moderate level and adjusted via a Bluetooth-connected application to ensure suitable pressure.
- Post-Intervention Monitoring: Following the massage session, participants will be instructed to resume normal daily activities but must refrain from structured exercise for three days. Participants will return to the laboratory at 24, 48, and 72 hours post-session to have their HRV recorded. All follow-up HRV measurements will be recorded at the same time of day to control for circadian variations.
Data Analysis and Mechanisms Heart rate data will be synced and analyzed using specialized software to calculate frequency-domain HRV indices. The analysis will specifically look at the high-frequency (HF) component, the low-frequency (LF) component, and the LF/HF ratio. The HF component primarily reflects parasympathetic activity, whereas the LF component represents a mixture of sympathetic and parasympathetic influences. The LF/HF ratio serves as an index of autonomic balance, with lower values indicating a state of parasympathetic dominance and enhanced recovery capacity. Tracking these metrics across multiple time points will allow researchers to observe the timeline of short-term autonomic changes and determine if habitual physical activity primes individuals to derive greater physiological recovery benefits from automated massage chair therapy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Kelantan
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Kubang Kerian, Kelantan, Malaysia, 16150
- Exercise and Sports Science Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Physically Inactive Group
Physically inactive participants undergo a single 20-minute treatment utilizing a commercial automated electric massage chair.
For the duration of the intervention, subjects rest in a heavily reclined position, allowing the device to fully support the head and torso while keeping the lower extremities elevated.The massage chair is programmed to execute the manufacturer's specific "Recharge" protocol.
This setting applies a combination of mechanical kneading and rolling motions across the upper and lower back, cervical region, arms, and thighs.To ensure consistency in perceived physical exertion, the mechanical force is customized per user.
Researchers calibrate the physical pressure through a wireless application, relying on the participant's verbal feedback to lock in a self-reported "moderate" intensity rating prior to the 20-minute session.
Heart rate variability is measured at pre, post 24-, post 48-, and post 72-hours massage intervention.
|
The intervention utilized the Ogawa Master Drive AI 2.0 massage chair, which is an advanced, fully automated, electrically powered unit featuring Bluetooth-enabled control via the Ogawa Wellness app.
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Active Comparator: Physically Active Group
Participants are active.The intervention consists of a single 20-minute standardized session in an automated electric massage chair.
Participants are positioned in a reclined posture where the back of the chair is nearly parallel to the floor, with their hips and knees flexed at 90 degrees or more, and their legs and feet elevated to heart level.The session utilizes a preset "Recharge" program designed to deliver moderate-intensity massage therapy.
The mechanical massage applies continuous, harmonized kneading and rolling techniques specifically targeting the back, neck, shoulders, forearms, and thighs.While the program is preset, participants subjectively self-select their perceived moderate pressure on a scale of 1 to 3. The massage intensity is then adjusted via Bluetooth using a paired application, ensuring the pressure is suitable and comfortable for each individual participant.
Heart rate variability is measured at pre, post 24-, post 48-, and post 72-hours massage intervention.
|
The intervention utilized the Ogawa Master Drive AI 2.0 massage chair, which is an advanced, fully automated, electrically powered unit featuring Bluetooth-enabled control via the Ogawa Wellness app.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability
Time Frame: Baseline, post 24-hours, post 48-hours, post 72-hours
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The primary outcome measures changes in autonomic nervous system regulation using frequency-domain indices of Heart Rate Variability (HRV). HRV is a non-invasive marker of sympathovagal balance.Three specific metrics are evaluated using Kubios software:
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Baseline, post 24-hours, post 48-hours, post 72-hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.
- Xie J, Fu M, Liu T, Li S, Liu G, Wang J, Ji C, Zhang T. Clinical studies on the electric automatic massage therapy for recovery of acute sports fatigue. Technol Health Care. 2023;31(S1):185-197. doi: 10.3233/THC-236016.
- Chen YS, Lu WA, Clemente FM, Bezerra JP, Kuo CD. Increased Parasympathetic Activity by Foot Reflexology Massage after Repeated Sprint Test in Collegiate Football Players: A Randomised Controlled Trial. Sports (Basel). 2019 Nov 3;7(11):228. doi: 10.3390/sports7110228.
- Yilmaz E, Aktop A, Abdioglu A, Melekoglu T, Nalbant M. The Effect of Heart Rate Variability Biofeedback on Recovery After Aerobic Exercise. Appl Psychophysiol Biofeedback. 2025 Mar;50(1):95-106. doi: 10.1007/s10484-024-09672-z. Epub 2024 Dec 4.
- Miyagi R, Sasawaki Y, Shiotani H. The influence of short-term sedentary behavior on circadian rhythm of heart rate and heart rate variability. Chronobiol Int. 2019 Mar;36(3):374-380. doi: 10.1080/07420528.2018.1550422. Epub 2018 Dec 3.
- Fazeli MS, Pourrahmat MM, Liu M, Guan L, Collet JP. The Effect of Head Massage on the Regulation of the Cardiac Autonomic Nervous System: A Pilot Randomized Crossover Trial. J Altern Complement Med. 2016 Jan;22(1):75-80. doi: 10.1089/acm.2015.0141. Epub 2015 Nov 12.
- Mat Isar NEN, Abdul Halim MHZ, Ong MLY. Acute massage stimulates parasympathetic activation after a single exhaustive muscle contraction exercise. J Bodyw Mov Ther. 2022 Apr;30:105-111. doi: 10.1016/j.jbmt.2022.02.016. Epub 2022 Feb 7.
- Forstenpointner J, Elman I, Freeman R, Borsook D. The omnipresence of autonomic modulation in health and disease. Prog Neurobiol. 2022 Mar;210:102218. doi: 10.1016/j.pneurobio.2022.102218. Epub 2022 Jan 13.
- Youn BY, Cho H, Joo S, Kim HJ, Kim JY. Utilization of massage chairs for promoting overall health and wellness: A rapid scoping review. Explore (NY). 2024 May-Jun;20(3):285-297. doi: 10.1016/j.explore.2023.10.002. Epub 2023 Oct 5.
- Baek JY, Lee E, Gil B, Jung HW, Jang IY. Clinical effects of using a massage chair on stress measures in adults: A pilot randomized controlled trial. Complement Ther Med. 2022 Jun;66:102825. doi: 10.1016/j.ctim.2022.102825. Epub 2022 Mar 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- USM/JEPeM/KK/24010104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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