UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031871
Receipt number R000036380
Scientific Title Effects of different exercise prescription on the quality of daily physical activity and health
Date of disclosure of the study information 2018/03/23
Last modified on 2019/09/24 10:03:16

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Basic information

Public title

Effects of different exercise prescription on the quality of daily physical activity and health

Acronym

Effects of different exercise prescription on the quality of daily physical activity and health

Scientific Title

Effects of different exercise prescription on the quality of daily physical activity and health

Scientific Title:Acronym

Effects of different exercise prescription on the quality of daily physical activity and health

Region

Japan


Condition

Condition

Non-communicable Diseases and locomotive syndrome including osteoporosis and sarcopenia

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to assess the effects of a physical activity intervention which aimed to increase habitual physical activity at a certain intensity using an activity monitor on quality of daily physical activity and health-related parameters under free-living conditions in young adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

physical activity pattern

Key secondary outcomes

physical fitness
blood biochemical parameters


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Observation group (no physical activity intervention)

Interventions/Control_2

Intervention group which aimed to increase habitual PA above a certain intensity (above the lactate threshold, moderate-to-vigorous or step counts) using an activity monitor

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

20 years-old <=

Age-upper limit

45 years-old >

Gender

Male and Female

Key inclusion criteria

Adults who are between 20 and 45 years of age

Key exclusion criteria

People who have concomitant diseases/injuries affecting enforcement of safety physical exercise, including 1) with a history of cardiovascular disease including recent myocardial infarction, 2) severe lever or kidney diseases, 3) hypertension or diabetes mellitus, 4) a person who is scheduled to have an operation (surgery), 5) a patient who is recovering/treatment from/in other serious diseases, and 6) During pregnancy

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hideaki
Middle name
Last name Kumahara

Organization

Nakamura Gakuen University

Division name

Faculty of Nutritional Sciences

Zip code

814-0198

Address

5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan

TEL

092-851-2531

Email

kumahara-h@umin.ac.jp


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Kumahara

Organization

Nakamura Gakuen University

Division name

Faculty of Nutritional Sciences

Zip code

814-0198

Address

5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan

TEL

092-851-2531

Homepage URL


Email

kumahara-h@umin.ac.jp


Sponsor or person

Institute

Nakamura Gakuen University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nakamura Gakuen University

Address

5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan

Tel

092-851-2531

Email

kks@nakamura-u.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

2018 Year 03 Month 23 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

Completed

Date of protocol fixation

2013 Year 04 Month 15 Day

Date of IRB

2013 Year 04 Month 15 Day

Anticipated trial start date

2013 Year 06 Month 04 Day

Last follow-up date

2018 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

2018 Year 03 Month 23 Day

Last modified on

2019 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036380


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name