UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051401 |
|---|---|
| Receipt number | R000058640 |
| Scientific Title | Efficacy of Cognitive Behavioral Therapy Combined with Exercise Guidance to Improve Physical Activity in Community-Dwelling Older Adults: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/08/15 |
| Last modified on | 2023/08/14 06:32:26 |
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Basic information
Public title
Clinical Trial of the Efficacy of Cognitive Behavioral Therapy Combined with Exercise Guidance to Improve Physical Activity in Community-Dwelling Older Adults
Acronym
A Study on Behavior Change to Increase Physical Activity among Older Adults
Scientific Title
Efficacy of Cognitive Behavioral Therapy Combined with Exercise Guidance to Improve Physical Activity in Community-Dwelling Older Adults: A Randomized Controlled Trial
Scientific Title:Acronym
Efficacy of CBT combined with exercise guidance on physical activity in older adults: RCT
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether there is a difference in the change in physical activity between Community-Dwelling Older Adults with and without cognitive behavioral therapy combined with exercise guidance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in total physical activity measured by International Physical Activity Questionnaire
Key secondary outcomes
moderate to vigorous physical activity, sedantory time, self efficacy for physical activity, number of steps, advers event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Cognitive behavioral therapy combined with exercise guidance
Interventions/Control_2
waiting-list
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
1) 65 years old or older
2) Residents in Tsukumi City, Oita prefecture
3) Able to walk on their own or with the use of a walking aid (cane, walker, etc.)
4) Able to communicate, read and write in Japanese
5) Understand the content of this study and give written consent to participate in the study of their own free will.
Key exclusion criteria
1) Cognitive function is impaired (as measured by Mini-Mental State Examination).
2) Exercise is prohibited by the family physician for medical reasons.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Eishi |
| Middle name | |
| Last name | Miyazaki |
Organization
Oita university faculty of medicine
Division name
department of general medicine
Zip code
879-5593
Address
1-1, Idaigaoka 1-chome, Hasama-cho, Yufu City, Oita Prefecture
TEL
097-586-5106
eishida@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Horinouchi |
Organization
Oita university faculty of medicine
Division name
department of general medicine
Zip code
879-5593
Address
1-1, Idaigaoka 1-chome, Hasama-cho, Yufu City, Oita Prefecture
TEL
097-586-5106
Homepage URL
nhorinouchi@oita-u.ac.jp
Sponsor or person
Institute
Oita University faculty medicine, department of general medicine
Institute
Department
Personal name
Funding Source
Organization
Department of General Medicine, Oita University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Interventional Clinical Research Review Committee, Oita University School of Medicine
Address
1-1, Idaigaoka 1-chome, Hasama-cho, Yufu City, Oita Prefecture
Tel
097-586-6163
gcrcjimu@oita-u.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
| 2023 | Year | 08 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058640
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
