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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033717
Receipt No. R000038447
Official scientific title of the study Effects of Chinese massage combined with soy milk supplement on the recovery of exercise fatigue and exercise performance
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/10

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Basic information
Official scientific title of the study Effects of Chinese massage combined with soy milk supplement on the recovery of exercise fatigue and exercise performance
Title of the study (Brief title) Effects of Chinese massage plus soy milk supplementation on post-exercise recovery
Region
Asia(except Japan)

Condition
Condition The healthy adults who routinely take exercise.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical benefits, such as post-exercise recovery and anti-fatigue effects, associated with ingestion of sugar-added soy milk beverage for the healthy adult with routinely take exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 5-km cycling time-trial test by bicycle ergometer at before main-exercise (15-km self-paced cycling exercise) and the next day.
Key secondary outcomes 1. Fatigue related scales (VAS, modified Borg scale)
2. Fatigue related biochemical examination of blood
3. Cognition related task performance
(They are assessed at before main-exercise (15-km self-paced cycling exercise) and the next day.)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The subjects are instructed to take commercially available sugar-added soy milk beverage at the time of immediately after the main-exercise (300 ml) and after the completion of post-exercise Chinese massage intervention (at one-hour after the main-exercise; 300 ml).
Interventions/Control_2 The subjects are instructed to take artificial sweeten pure water at the time of immediately after the main-exercise (300 ml) and after the completion of post-exercise Chinese massage intervention (at one-hour after the main-exercise; 300 ml).
Interventions/Control_3 The subjects are instructed to take artificial sweeten pure water at the time of immediately after the main-exercise (300 ml) and at one-hour after the main-exercise (300 ml). [Chinese massage intervention].
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
20 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who routinely take exercise.
3. Subjects who have no clinical skeletomuscular problems within 12-weeks prior to the study.
4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria 1. Subjects with respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who can't take exercise tolerance by bicycle ergometer.
3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
4. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
5. Subjects who have cognitive disorder or who have possibility of the disorder.
6. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size 16

Research contact person
Name of lead principal investigator Yi-Hung Liao
Organization National Taipei University of Nursing and Health Sciences
Division name Department of Exercise and Health Science
Address Taipei City
TEL +886228227101
Email yihungliao.henry@gmail.com

Public contact
Name of contact person Yi-Hung Liao
Organization National Taipei University of Nursing and Health Sciences
Division name Department of Exercise and Health Science
Address No.365, Ming-Te Road, Peitou District,, Taipei City
TEL +886228227101
Homepage URL
Email yihungliao.henry@gmail.com

Sponsor
Institute National Taipei University of Nursing and Health Sciences
Institute
Department

Funding Source
Organization National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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 National Taipei University of Nursing and Health Sciences (Taipei City, Taiwan)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 31 Day
Anticipated trial start date
2018 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 10 Day
Last modified on
2018 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038447

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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