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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038438
Receipt No. R000043796
Scientific Title Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial
Date of disclosure of the study information 2019/11/10
Last modified on 2019/10/30

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Basic information
Public title Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial
Acronym Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial
Scientific Title Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial
Scientific Title:Acronym Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial
Region
Japan

Condition
Condition elderly people requiring support or care
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether buddy-style intervention among community-dwelling elderly people is effective for improving exercise adherence
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exercise adherence
Key secondary outcomes Number of falls, Short Physical Performance Battery, Exercise self-efficacy, Apathy scale, Health Locus of Control scale, Grip strength, Knee extension muscle strength, Subjective health

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The physical therapy handbook (healthy life expectancy) published by the Japan Physical Therapist Association is handed over to the subjects, and the physical therapist's advice is given to select three exercises. Each intervention group becomes a pair (buddy), and the buddies report the progress of exercise every week and receive behavioral change interventions such as social support, feedback, and monitoring.
Interventions/Control_2 The physical therapy handbook (healthy life expectancy) published by the Japan Physical Therapist Association is handed over to the subject, and the subject chooses three exercises themselves.
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

Not applicable
Gender Male and Female
Key inclusion criteria Aged 65 years or older living in a home or residential facility

gait independence
Key exclusion criteria Severe visual impairment that prevents you from reading an exercise program form or completing an exercise logbook

Cognitive impairment
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiromichi
Middle name
Last name Takeda
Organization Kio University
Division name Division of Health Science, Graduate School
Zip code 635-2832
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL 0745-54-1601
Email hiromichi.takeda0608@gmail.com

Public contact
Name of contact person
1st name Hiromichi
Middle name
Last name Takeda
Organization Kio University
Division name Division of Health Science, Graduate School
Zip code 635-2832
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL 0745-54-1601
Homepage URL
Email hiromichi.takeda0608@gmail.com

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kio University
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
Tel 0745-54-1602
Email soumu@kio.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
2019 Year 11 Month 10 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
2019 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 04 Day
Last follow-up date
2020 Year 10 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
2019 Year 10 Month 30 Day
Last modified on
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043796

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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