UMIN-CTR Clinical Trial

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
Email	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
Email	Kim1228_0819@yahoo.co.jp

Sponsor
Institute	Sonoda third hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049340