UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040588 |
|---|---|
| Receipt number | 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 | 2021/11/30 11:57:03 |
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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
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
yudaisasaki0@gmail.com
Sponsor or person
Institute
Graduate school of the open university of Japan
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 03 | Day |
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
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046322
