UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046678 |
|---|---|
| Receipt number | R000053080 |
| Scientific Title | Relationship between psychosocial function and exercise adherence and physical activity among community-dwelling elderly people Exercise Adherence and Physical Activity -A Randomized, Controlled Trial of Acceptance and Commitment Therapy (ACT) Intervention |
| Date of disclosure of the study information | 2022/01/20 |
| Last modified on | 2022/01/20 05:10:53 |
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Basic information
Public title
Relationship between psychosocial function and exercise adherence and physical activity among community-dwelling elderly people
Exercise Adherence and Physical Activity
-A Randomized, Controlled Trial of Acceptance and Commitment Therapy (ACT) Intervention
Acronym
Relationship between psychosocial function and exercise adherence and physical activity among community-dwelling elderly people
Exercise Adherence and Physical Activity
-A Randomized, Controlled Trial of Acceptance and Commitment Therapy (ACT) Intervention
Scientific Title
Relationship between psychosocial function and exercise adherence and physical activity among community-dwelling elderly people
Exercise Adherence and Physical Activity
-A Randomized, Controlled Trial of Acceptance and Commitment Therapy (ACT) Intervention
Scientific Title:Acronym
Relationship between psychosocial function and exercise adherence and physical activity among community-dwelling elderly people
Exercise Adherence and Physical Activity
-A Randomized, Controlled Trial of Acceptance and Commitment Therapy (ACT) Intervention
Region
| Japan |
Condition
Condition
Elderly people requiring support or long-term care
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of ACT intervention on the improvement of physical activity and the process of change in the psychological process of individuals leading to the improvement of physical activity in elderly people living in the community.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Adherence to 150-300 minutes of medium- to high-intensity activity (MVPA (>3.0 Mets)) at the end of the intervention (12 weeks) and at subsequent follow-up (weeks 15 and 24).
Key secondary outcomes
Time of MVPA implementation at the end of the randomized intervention (after 12 weeks).
Time of MVPA implementation at 15 and 24 weeks after the end of the randomized intervention.
Filling in missing data by multiple induction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Regular exercise program group: Nine types of machine training, which is the exercise program used in the day-care rehabilitation program at our hospital, and individual rehabilitation by a rehabilitation specialist for 10 minutes will be conducted. At the time of the individual rehabilitation, the results of the weekly physical activity will be presented and feedback will be given by the rehabilitation specialist. (Two versions of Behavior Change Technique Taxonomy version 1, BCTTv1 (Michie et al. 2013) were used.)
Interventions/Control_2
The ACT skills will consist of a total of eight sessions: "Thinking about Physical Activity" will focus on motivating people to increase physical activity by encouraging them to think about the reasons for increasing physical activity and providing information about the common health hazards of physical activity and physical inactivity. The "Think about Physical Activity" session focuses on motivating people to increase physical activity by encouraging them to think about the reasons for increasing physical activity and providing information about the common health hazards of physical activity and physical inactivity. Preparing for Increased Physical Activity provides information on planning for increased physical activity, physical inactivity behaviors, triggers, identifying reasons for increased physical activity, identifying social support for increased physical activity, and WHO guidelines for recommended amounts of physical activity. Physical Activity introduces skills such as finding alternative activities (e.g., going shopping) and staying busy to avoid the desire to rest. Continuing Physical Activity provides tips for continuing physical activity, motivation, action, and skills for coping with cravings, such as fighting cravings and staying positive. (Using six ACT+Behavior Change Technique Taxonomy version 1, BCTTv1 (Michie et al. 2013))
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
Among the users of the day-care rehabilitation at our hospital, those who are 65 years old or older, who can fill out the self-administered questionnaire, and who can walk by themselves.
Key exclusion criteria
1) People with health problems such as Alzheimer's disease, Parkinson's disease, depression, etc. health problems such as Alzheimer's disease, Parkinson's disease, or depression.
2) Those who have difficulty in understanding instructions
3) Those with missing data on exclusion criteria.
4) Those who need assistance with basic daily living.
5) Those for whom consent was not obtained from the patient or the patient's family.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasutada |
| Middle name | |
| Last name | Yamamoto |
Organization
Department of Therapy, Takarazuka Rehabilitation Hospital, Medical Corporation SYOWAKAI
Division name
Medical Department
Zip code
665-0833
Address
22-2 Tsurunoso, Takarazuka-shi, Hyogo, 665-0833, Japan
TEL
0797-81-2345
yasutada.yamamoto1210@gmail.com
Public contact
Name of contact person
| 1st name | Yasutada |
| Middle name | |
| Last name | Yamamoto |
Organization
Department of Therapy, Takarazuka Rehabilitation Hospital, Medical Corporation SYOWAKAI
Division name
Medical Department
Zip code
665-0833
Address
22-2 Tsurunoso, Takarazuka-shi, Hyogo, 665-0833, Japan
TEL
0797-81-2345
Homepage URL
yasutada.yamamoto1210@gmail.com
Sponsor or person
Institute
Department of Therapy, Takarazuka Rehabilitation Hospital, Medical Corporation SYOWAKAI
Institute
Department
Personal name
Funding Source
Organization
Yuumi Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for Health Promotion, Graduate School of Health Sciences, Kinoh University
Nagasaki University Hospital Clinical Research Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Therapy, Takarazuka Rehabilitation Hospital, Medical Corporation SYOWAKAI
Address
22-2 Tsurunoso, Takarazuka-shi, Hyogo, 665-0833, Japan
Tel
0797-81-2345
yasutada.yamamoto1210@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-1-2
Org. issuing International ID_1
Department of Therapy, Takarazuka Rehabilitation Hospital, Medical Corporation SYOWAKAI
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人尚和会 宝塚リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 20 | 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
| 2022 | Year | 01 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 20 | Day |
Last modified on
| 2022 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053080
