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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053080


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name