UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052486