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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035520
Receipt No. R000040468
Scientific Title Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Date of disclosure of the study information 2019/01/11
Last modified on 2019/01/11

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Basic information
Public title Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Acronym Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Scientific Title Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Scientific Title:Acronym Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Region
Japan

Condition
Condition Young and Middle-aged and older adults including of obese adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate whether chronic exercise modulates circulating peptide hormone levels to prevent sarcopenia and chronic diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effects of chronic exercise on circulating peptide hormone levels
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Young subjects undertook a chronic aerobic exercise using cycle ergometer. The aerobic exercise-training program consisted of cycling on a leg ergometer for 45-55 min, 60-70% of maximal oxygen uptake, 3 days/week, for 8-12 weeks.
Interventions/Control_2 Middle-aged and older subjects undertook a chronic aerobic exercise using cycle ergometer. The aerobic exercise-training program consisted of cycling on a leg ergometer for 45-55 min, 60-70% of maximal oxygen uptake, 3 days/week, for 8-12 weeks.
Interventions/Control_3 Young subjects undertook a chronic resistance exercise. The resistance exercise-training program to whole body consisted for 10 repetitions, 3 sets, 60-70% of repetition maximum, 3 days/week, for 8-12 weeks.
Interventions/Control_4 Middle-aged and older subjects undertook a chronic resistance exercise. The resistance exercise-training program to whole body consisted for 10 repetitions, 3 sets, 60-70% of repetition maximum, 3 days/week, for 8-12 weeks.
Interventions/Control_5 Non intervention(Young subjects)
Interventions/Control_6 Non intervention(Middle-aged and older subjects)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Subjects who should not ban or limit exercise therapy by the doctor
2)Subjects who don't have some therapies and/or medications
3)Subjects who are capable of making a decision by themselves, and provide written consent
Key exclusion criteria 1)Patients with hepatic dysfunction and/or renal dysfunction
2)Patients with cardiovascular diseases
3)Pregnant or plans to become pregnant during the study period
4)Patients with limited exercise therapy
5)Others who judged inappropriate by the examining physician
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoyuki Iemitsu
Organization Ritsumeikan University
Division name Faculty of Sport and Health Science
Zip code
Address 1-1-1 Noji-higashi, Kusatsu, Shiga
TEL 077-599-4131
Email iemitsu@fc.ritsumei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoyuki Iemitsu
Organization Ritsumeikan University
Division name Faculty of Sport and Health Science
Zip code
Address 1-1-1 Noji-higashi, Kusatsu, Shiga
TEL 077-599-4131
Homepage URL
Email iemitsu@fc.ritsumei.ac.jp

Sponsor
Institute Ritsumeikan University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 11 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 11 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040468

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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