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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046132
Receipt No. R000052486
Scientific Title Effect of physical activity and well-being and social capital by the formation of a small community of elderly patients with cardiovascular disease in the maintenance of cardiac rehabilitation: randomized comparative study of multicenter
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/21

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Basic information
Public title Effect of physical activity and well-being and social capital by the formation of a small community of elderly patients with cardiovascular disease in the maintenance of cardiac rehabilitation: randomized comparative study of multicenter
Acronym PWS-Study
Scientific Title Effect of physical activity and well-being and social capital by the formation of a small community of elderly patients with cardiovascular disease in the maintenance of cardiac rehabilitation: randomized comparative study of multicenter
Scientific Title:Acronym PWS-Study
Region
Japan

Condition
Condition cardiovascular disease
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main goal of this study is to ascertain whether small community walking (the walking in a group three people) could lead to more significant changes in physical activity, well-being and social capital among elderly patients with cardiovascular disease compared to walking alone, during and after an intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical activity (the average daily step count for two weeks)
Key secondary outcomes 1) Happiness scale, 2) Social capital, 3) Quality of life (SF-8), 4) Cardiovascular risk factors and cardiac function, 5) 6-min walking distance, 6) Frailty

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 Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 After completing measurements before the intervention, patients with cardiovascular disease are randomly allocated to the small community walking group (SCW group) or the walking alone group (WA group). Patients of both groups undergo a three-month intervention by registered Instructor of Cardiac Rehabilitation (RICR).
The patients of SCW group walk in groups of three people with their family, friends or local walking volunteers to utilize the power of peer pressure. The patients are informed that they would walk in groups of three people about once a week. After the three-month intervention, the participants are not asked to walk with their peers. However, they can decide for themselves whether to walk or not. Before the intervention, each group are assessed. Measurements of physical activity, social capital and happiness are performed before and after each intervention. Additionally, the effects of the activity maintenance are measured six months after the intervention.
Interventions/Control_2 The WA group walks alone. The WA group uses the same protocol as the SCW group.
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
60 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with cardiovascular disease between the ages of 60 and 80
2. Patients with cardiovascular disease who can understand the content of exercise
Key exclusion criteria 1. Patients with heart disease who have difficulty walking with strong pain in the knees and lower back
2. Walking is stopped by the doctor
3. mental illness
4. Cognitive function is impaired
5. Already walking in multiples
Target sample size 116

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Yamashita
Organization Kumamoto Institute of total fitness
Division name Health science department
Zip code 860-8518
Address 6-8-1 Yamamuro, Kita-ku, Kumamoto
TEL 096-345-8113
Email ryo513@hotmail.co.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Yamashita
Organization Kumamoto Institute of Total Fitness
Division name Health science department
Zip code 860-8518
Address 6-8-1 Yamamuro, Kita-ku, Kumamoto
TEL 096-345-8113
Homepage URL
Email ryo513@hotmail.co.jp

Sponsor
Institute Kumamoto Kinoh Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
(Japan Sports Agency)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kumamoto Kinoh Hospital
Address 6-8-1 Yamamuro, Kita-ku, Kumamoto
Tel 0963458111
Email mcjhealth@juryo.or.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
2021 Year 12 Month 01 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
2021 Year 10 Month 13 Day
Date of IRB
2021 Year 10 Month 13 Day
Anticipated trial start date
2021 Year 10 Month 13 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 21 Day
Last modified on
2021 Year 11 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052486

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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