UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038438 |
|---|---|
| Receipt number | 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 | 2023/05/03 11:25:48 |
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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
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
hiromichi.takeda0608@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
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
https://doi.org/10.1177/02692155211041104
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1177/02692155211041104
Number of participants that the trial has enrolled
65
Results
The analysis of exercise adherence was performed on the 54 participants (intervention, n=28, control, n=26) for whom the final responses were available. The between-group effect showed that the intervention group was significantly higher than the control group in phase 3 of the exercise adherence assessment (p = 0.009, f = 0.4). On the other hand, the control group was significantly better than the intervention group in tandem standing time after 12 weeks (p = 0.049, f = 0.2).
Results date posted
| 2023 | Year | 05 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Support/care-need disabled older adults in the long-term care insurance system were recruited from three adult day-care centers in Osaka City, Japan, between June 2020 and July 2020. The criteria for selecting participants were older adults aged >65 who lived in the community and could walk independently.
Exclusion criteria were those with visual impairment or deterioration of upper limb/finger function who would be incapable of writing in an exercise log calendar, and those with moderate and severe cognitive impairment in which the independence degree of daily living for the demented elderly was IIb or higher.
Participant flow
In total, 590 older adults of three adult day-care centers in Osaka, Japan, were checked for eligibility in August 2020. During the 12-week intervention period from September 2020 to December 2020, a total of nine participants dropped out (intervention = 4, control = 5). The mean adherence for the buddy-style intervention was 9.7/12 times (81%).
Adverse events
None
Outcome measures
Exercise adherence (primary outcome)
Handgrip strength
Knee extension strength
Self-efficacy for exercise scale
Apathy scale
Health locus of control scale
Self-rated health
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 27 | Day |
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
| 2023 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043796
