UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035434
Receipt number 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 2019/07/09 15:30:34

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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

Name of lead principal investigator

1st name Nozomi
Middle name
Last name DONOYAMA

Organization

Tsukuba University of Technology

Division name

Faculty of Health Sciences

Zip code

305-8521

Address

4-12-7 Kasuga, Tsukuba, Ibaraki, 305-8521 Japan

TEL

81+29-858-9631

Email

donoyama@k.tsukuba-tech.ac.jp


Public contact

Name of contact person

1st name Nozomi
Middle name
Last name DONOYAMA

Organization

Tsukuba University of Technology

Division name

Faculty of Health Sciences

Zip code

305-8521

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 or person

Institute

Faculty of Health Sciences, Tsukuba University of Technology

Institute

Department

Personal name



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

Tsukuba University of Technology

Address

4-3-15 Amakubo, Tsukuba, Ibaraki, 305-8520 Japan

Tel

81+29-858-9415

Email

kenkyo@ad.tsukuba-tech.ac.jp


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

12

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

Completed

Date of protocol fixation

2018 Year 12 Month 14 Day

Date of IRB

2018 Year 12 Month 14 Day

Anticipated trial start date

2019 Year 01 Month 08 Day

Last follow-up date

2019 Year 03 Month 13 Day

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 07 Month 09 Day



Link to view the page

Value
https://center6.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