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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | None | ||
Classification by specialty |
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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
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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 |
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Interventions/Control_1 | Group walking in a rich natural environment 6 weeks
Home exercise |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 65 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |