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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040588
Receipt No. R000046322
Scientific Title Effects of group walking in forests and hills on physical and mental functions of community-dwelling elderly
Date of disclosure of the study information 2020/06/01
Last modified on 2020/12/07

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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


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