UMIN-CTR Clinical Trial

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
Email	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
Email	yasutada.yamamoto1210@gmail.com

Sponsor
Institute	Department of Therapy, Takarazuka Rehabilitation Hospital, Medical Corporation SYOWAKAI
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053080