UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024651
Receipt number R000028361
Scientific Title Development of exercise prescription program for prevention of sarcopenia
Date of disclosure of the study information 2016/10/31
Last modified on 2021/11/04 12:47:20

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Basic information

Public title

Development of exercise prescription program for prevention of sarcopenia

Acronym

Development of exercise prescription for sarcopenia

Scientific Title

Development of exercise prescription program for prevention of sarcopenia

Scientific Title:Acronym

Development of exercise prescription for sarcopenia

Region

Japan


Condition

Condition

Sarcopenia

Classification by specialty

Medicine in general Cardiology Orthopedics

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To develop the exercise prescription program for prevention and treatment both sarcopenia and metabolic syndrome

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle mass, muscle strength and gait speed

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Non intervention

Interventions/Control_2

Exercise

Interventions/Control_3

Diet,

Interventions/Control_4

Exercise+Diet

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Men SMI<7.0
Women SMI<5.4

Key exclusion criteria

Stroke, CHD

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Kiyoshi
Middle name
Last name Sanada

Organization

Ritsumeikan University

Division name

Sport and Health Science

Zip code

525-8577

Address

1-1-1 Nojihigashi, Kusatsu, 525-8577, Japan

TEL

077-561-2674

Email

ksanada@fc.ritsumei.ac.jp


Public contact

Name of contact person

1st name Kiyoshi
Middle name
Last name Sanada

Organization

Ritsumeikan University

Division name

Sport and Health Science

Zip code

525-8577

Address

1-1-1 Nojihigashi, Kusatsu, 525-8577, Japan

TEL

0775612674

Homepage URL


Email

ksanada@fc.ritsumei.ac.jp


Sponsor or person

Institute

Ritsumeikan University

Institute

Department

Personal name



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

Ritsumeikan University IRB

Address

1-1-1 Nojihigashi, Kusatsu

Tel

077-599-4175

Email

b-rinri@st.ritsumei.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



Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 31 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

Hamaguchi K, Kurihara T, Fujimoto M, Sato K, Iemitsu M, Hamaoka T, Sanada K. International Journal of Environmental Research and Public Health, 2020 Mar; 17(5): E1620.
Nishimura T, Imai A, Fujimoto M, Kurihara T, Kagawa K, Nagata T, Sanada K. Journal of Physical Therapy Science, 2020 Mar; 32(3): pp227-232.

Results date posted

2021 Year 11 Month 04 Day

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

2016 Year 08 Month 03 Day

Date of IRB

2011 Year 11 Month 29 Day

Anticipated trial start date

2016 Year 10 Month 31 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 31 Day

Last modified on

2021 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028361


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name