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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035434
Receipt No. R000040258
Scientific Title Contribution of massage therapy to health as a preventive strategy: A pilot randomized controlled trial
Date of disclosure of the study information 2019/01/03
Last modified on 2019/01/03

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Basic information
Public title Contribution of massage therapy to health as a preventive strategy: A pilot randomized controlled trial
Acronym Pilot RCT of massage therapy as a preventive strategy for health
Scientific Title Contribution of massage therapy to health as a preventive strategy: A pilot randomized controlled trial
Scientific Title:Acronym Pilot RCT of massage therapy as a preventive strategy for health
Region
Japan

Condition
Condition Obesity
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to explore whether two kinds of massage therapies that are generally utilized in Japan can contribute to health as a preventive strategy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Concentration level of adiponectin in blood
Key secondary outcomes Weight, abdominal circumference, and body fat percentage. Concentration levels of leptin, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and high-sensitivity C-reactive protein in blood. Self-reported questionnaire of Profile of Mood State 2nd Edition (POMS2).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A 40-min whole-body massage session (excluding head, face, and breasts) was administered once a week for 2 months (8 sessions total). Massage was performed directly on the skin using oil.
Interventions/Control_2 A 40-min whole-body Japanese Anma massage session (excluding head, face, and breasts) was administered once a week for 2 months (8 sessions total). Anma massage therapy is a form of Japanese massage therapy and is performed through the clothing without oil.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria Healthy middle-aged and old women (age >= 40 years) who were designated obese (body mass index >= 25 as defined by the Japan Society for the Study of Obesity) on medical examination in the past 1 year and were thinking of reducing their obesity, but have not yet received any treatment.
Key exclusion criteria (1) Undergoing treatment or follow-up by a medical doctor for cardiovascular disease or cerebrovascular disease.
(2) Undergoing treatment or follow-up by a medical doctor for any other serious disease.
(3) Currently receiving massage therapy.
Target sample size 24

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Nozomi DONOYAMA
Organization Tsukuba University of Technology
Division name Faculty of Health Sciences
Zip code
Address 4-12-7 Kasuga, Tsukuba, Ibaraki, 305-8521 Japan
TEL 81+29-858-9631
Email donoyama@k.tsukuba-tech.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Nozomi DONOYAMA
Organization Tsukuba University of Technology
Division name Faculty of Health Sciences
Zip code
Address 4-12-7 Kasuga, Tsukuba, Ibaraki, 305-8521 Japan
TEL 81+29-858-9631
Homepage URL
Email donoyama@k.tsukuba-tech.ac.jp

Sponsor
Institute Faculty of Health Sciences, Tsukuba University of Technology
Institute
Department

Funding Source
Organization Tsukuba University of Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Tsukuba University of Technology

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 03 Day
Last modified on
2019 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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