UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043236 |
|---|---|
| Receipt number | R000049340 |
| Scientific Title | Development of a Clinical Prediction Rule for Text Messaging to increase physical activity in patients with heart disease |
| Date of disclosure of the study information | 2021/02/10 |
| Last modified on | 2021/02/03 08:32:09 |
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Basic information
Public title
Development of a Clinical Prediction Rule for Text Messaging to increase physical activity in patients with heart disease
Acronym
Development of a Clinical Prediction Rule for Text Messaging to increase physical activity in patients with heart disease
Scientific Title
Development of a Clinical Prediction Rule for Text Messaging to increase physical activity in patients with heart disease
Scientific Title:Acronym
Development of a Clinical Prediction Rule for Text Messaging to increase physical activity in patients with heart disease
Region
| Japan |
Condition
Condition
Heart Disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a clinical prediction rule for text messaging to increase physical activity in patients with heart disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who can walk alone or using only a T-cane.
2)Those who can receive text messages.
Key exclusion criteria
1)Patient with doctor's exercise restriction order.
2)History of cerebrovascular disease, neuromuscular disease,or Musculoskeletal disorder.
3)Mini-Mental State Exmination Less than 24points.
4)Difficult to manage physical activity tracker.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kimura |
Organization
Sonoda third hospital
Division name
Department of Rehabilitation
Zip code
1210807
Address
2-5-10 Ikohoncho,Adachi-ku,Tokyo
TEL
03-5837-5111
Kim1228_0819@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kimura |
Organization
Sonoda third hospital
Division name
Department of Rehabilitation
Zip code
1210807
Address
2-5-10 Ikohoncho,Adachi-ku,Tokyo
TEL
03-5837-5111
Homepage URL
Kim1228_0819@yahoo.co.jp
Sponsor or person
Institute
Sonoda third hospital
Institute
Department
Personal name
Funding Source
Organization
Sonoda third hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sonoda ethics committee
Address
1-21-10, Hokima, Adachi, Tokyo
Tel
03-5831-1843
irb@sonodakai.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 | 02 | Month | 10 | 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
| 2021 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 10 | 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
Prospective cohort study
Management information
Registered date
| 2021 | Year | 02 | Month | 03 | Day |
Last modified on
| 2021 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049340
