UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of effects of exercise programs for the elderly to be treated prior to the colonoscopy treatment
Title of the study (Brief title)	Study of effects of exercise programs for the elderly to be treated prior to the colonoscopy treatment
Region	Japan

Condition
Condition	Bowel disease
Classification by specialty	Gastroenterology Gastrointestinal surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Carried out in exercise program elderly receiving treatment before the colonoscopy treatment to examine the effect
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Or addede in the imaplementation group and the non-implementation group exericise program treatment has decreased
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Exercise program implementation
Interventions/Control_2	Exercise program not yet implemented
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The person who receives the pre-trearment in the intestinal tract cleaning solution Mobipureppu
Key exclusion criteria	People can not own walking
Target sample size	30

Research contact person
Name of lead principal investigator	Miki Satou
Organization	Japan Community Health care Organization Gunma Chuo Hospital
Division name	8th floor ward
Address	Gunmaken maebasisi kouncho 1-7-13
TEL	027-221-8165
Email	tabei-yasuhiro@gunma.jcho.go.jp

Public contact
Name of contact person	Miki Satou
Organization	Japan Community Health care Organization Gunma Chuo Hospital
Division name	8th floor ward
Address	Gunmaken maebasisi koucho 1-7-13
TEL	027-221-8165
Homepage URL
Email	tabei-yasuhiro@gunma.jcho.go.jp

Sponsor
Institute	Japan Community Health care Organization Gunma Chuo Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Community Health care Organization Gunma Chuo Hospital
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 27 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 22 Day
Anticipated trial start date	2016 Year 07 Month 27 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	2016 Year 07 Month 25 Day
Last modified on	2016 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026872