UMIN-CTR Clinical Trial

Basic information
Public title	Implication of interval walking training in rehabilitation
Acronym	Implication of interval walking training in rehabilitation
Scientific Title	Impact of interval walking training on cognitive function in convalescent rehabilitation patients
Scientific Title:Acronym	Impact of interval walking training on cognitive function in convalescent rehabilitation patients
Region	Japan

Condition
Condition	Rehabilitation patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine any impact of interval walking training on cognitive function in convalescent rehabilitation patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Interval walking training
Interventions/Control_2	Constant speed walking training
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	65 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Those who are not less than 65 years old at their agreement to participate in the study. 2) Those who have no orthopedic symptoms to disturb walking training. 3) Those who can perform walking training. 4) Those who can walk continuously at a 90m distance in a hall of a hospital at least one month before participating the study. 5) Those who we can get their informed consent from before participating the study.
Key exclusion criteria	1) Those who do not clear the criteria stated above. 2) Those who a chief investigator does not recognize appropriate.
Target sample size	30

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	Government offices of other countries
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	2021 Year 08 Month 12 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	Enrolling by invitation
Date of protocol fixation	2021 Year 08 Month 10 Day
Date of IRB	2021 Year 08 Month 10 Day
Anticipated trial start date	2021 Year 08 Month 10 Day
Last follow-up date	2022 Year 07 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	2021 Year 08 Month 12 Day
Last modified on	2021 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051564