UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046132 |
|---|---|
| Receipt number | 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 00:21:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ryo513@hotmail.co.jp
Sponsor or person
Institute
Kumamoto Kinoh Hospital
Institute
Department
Personal name
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
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
Value
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 |
