UMIN-CTR Clinical Trial

Basic information
Public title	Effects of group walking in forests and hills on physical and mental functions of community-dwelling elderly
Acronym	Effects of group walking in a rich natural environment
Scientific Title	Effects of group walking in forests and hills on physical and mental functions of community-dwelling elderly
Scientific Title:Acronym	Effects of group walking in a rich natural environment
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effects of walking in the forest and hills on physical function such as walking ability, muscle strength of lower limbs, balance function, and mental function such as mood change due to exercise in community-dwelling elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical activity
Key secondary outcomes	Grip Strength Physical fitness questionnaire Mood profile test Social capital assessment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Other
Interventions/Control_1	Group walking in a rich natural environment 6 weeks Home exercise
Interventions/Control_2	Home exercise
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	80 years-old >
Gender	Female
Key inclusion criteria	1) Those who can walk independently without a cane or other walking aid 2) None of lower limb pain, trauma or no history of surgery 3) None of neuromuscular disorders 4) No acute or chronic illness that significantly reduce muscle strength 5) Grip strength of 10 kg or over and walking speed of 0.5 m/sec or over 6) Can stand on one leg for more than 5 seconds on both sides
Key exclusion criteria	1) History of stroke with severe hemiplegia (Brunnstrom Stage Grade 5 and lower) 2) Parkinson disease or Parkinsonism 3) Uncontrolled diabetes (HbA1c value is 10% or more) 4) Using a cardiac pacemaker 5) Extreme loss of vision or total blindness 6) Having orthopedic surgery such as artificial knee or hip replacement
Target sample size	65

Research contact person
Name of lead principal investigator	1st name Yudai Middle name Last name Sasaki
Organization	Graduate school of the open university of Japan
Division name	Human Life and Health Sciences Program
Zip code	261-8586
Address	2-11 Wakaba, Mihama-ku, Chiba city, Chiba, Japan
TEL	080-6006-6335
Email	yudaisasaki0@gmail.com

Public contact
Name of contact person	1st name Yudai Middle name Last name Sasaki
Organization	Graduate school of the open university of Japan
Division name	Human Life and Health Sciences Program
Zip code	261-8586
Address	2-11 Wakaba, Mihama-ku, Chiba city, Chiba, Japan
TEL	080-6006-6335
Homepage URL
Email	yudaisasaki0@gmail.com

Sponsor
Institute	Graduate school of the open university of Japan
Institute
Department

Funding Source
Organization	Mitane town office, Akita, Japan
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate school of the open university of Japan
Address	2-11 Wakaba, Mihama-ku, Chiba city, Chiba, 261-8586, Japan
Tel	043-276-5111
Email	rinrishinsa@ouj.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	2020 Year 06 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2021 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 30 Day
Last modified on	2020 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046322

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.