UMIN-CTR Clinical Trial

Basic information
Public title	The study on the preventive and therapeutic effects of increased physical fitness by interval walking training on age-associated diseases in middle-aged and older people
Acronym	The study on effects of increased physical fitness by interval walking training on age-associated diseases
Scientific Title	The stratified analysis on the preventive and therapeutic effects of increased physical fitness by long termed interval walking training on age-associated diseases in middle-aged and older people
Scientific Title:Acronym	The stratified analysis on the effects of increased physical fitness by interval walking training on age-associated diseases
Region	Japan

Condition
Condition	Age associated diseases
Classification by specialty	Medicine in general Endocrinology and Metabolism Neurology Psychosomatic Internal Medicine Geriatrics Orthopedics Anesthesiology Laboratory medicine Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To examine the preventive and therapeutic effects of increased physical fitness by interval walking training for 5 months on age-associated diseases in middle-aged and older people
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The maximal aerobic capacity before and after interval walking training for 5 months.
Key secondary outcomes	Age-associated disease symptoms; the symptoms of life-style related diseases (hypertension, hyperglycemia, obesity and dyslipidemia), orthopedic diseases (chronic osteoarthritis and osteoporosis), and psychiatric disorders (insomnia, depression, and dementia)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Interval walking training
Interventions/Control_2
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	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Those who can walk independently. 2) Those who have received their home doctors' permission to participate in the study. 3) Those who gave us their informed consents after explained about the details of the study.
Key exclusion criteria	1) Those who do not meet the inclusion criteria. 2) Those who are judged to be inappropriate for participating the study by the lead principal investigator.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Shizue Middle name Last name Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Zip code	390-8621
Address	3-1-1 Asahi Matsumoto Nagano
TEL	0263372682
Email	masuki@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Shizue Middle name Last name Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Zip code	390-8621
Address	3-1-1 Asahi Matsumoto Nagano
TEL	0263372682
Homepage URL
Email	masuki@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Shinshu University
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	Shinshu University School of Medicine
Address	3-1-1 Asahi Matsumoto Nagano
Tel	0263372572
Email	mdrinri@shinshu-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	2022 Year 04 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	Enrolling by invitation
Date of protocol fixation	2005 Year 07 Month 05 Day
Date of IRB	2005 Year 07 Month 05 Day
Anticipated trial start date	2005 Year 07 Month 05 Day
Last follow-up date	2027 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	2022 Year 04 Month 07 Day
Last modified on	2022 Year 04 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054037