UMIN-CTR Clinical Trial

Basic information
Public title	Effects of ACuTe phase IntensiVE Physical Activity Monitoring and education for patients with cardiovascular disease: A prospective, randomised, parallel-group, outcome blinded, controlled, factorial, pilot study.
Acronym	ACTIVE PA-Monitoring pilot trial
Scientific Title	Effects of ACuTe phase IntensiVE Physical Activity Monitoring and education for patients with cardiovascular disease: A prospective, randomised, parallel-group, outcome blinded, controlled, factorial, pilot study.
Scientific Title:Acronym	ACTIVE PA-Monitoring pilot trial
Region	Japan

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

Objectives
Narrative objectives1	To examine the usefulness of patient education using physical activity monitoring devices for patients with cardiovascular disease during hospitalization.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean physical activity during hospitalization
Key secondary outcomes	Change in lower extremity function from baseline to discharge (gait speed, SPPB) Change in physical activity from baseline to discharge Six-minute walk distance at discharge Health-related QOL at discharge (KCCQ-12, SF-36 physical function)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	1) Usual Care 2) Physical activity education using multi-person physical activity monitor
Interventions/Control_2	1) Usual Care
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients hospitalized for cardiovascular disease 2) Aged 18 years or older
Key exclusion criteria	Significant myocardial ischemia during low-intensity exercise Acute infective endocarditis, myocarditis, and pericaritis Severe symptomatic aortic stenosis, mitral stenosis, and hypertrophic obstructive cardiomyopathy Severe pulmonary hypertension Intracardiac thrombus Untreated life-threatening arrhythmia Patients with circulatory assist device History of aortic dissection, or presence of aortic aneurysm or aortic dissection Patients with uncontrolled diabetes Peripheral arterial disease (Fontain 3-4) Recent embolism Patients undergoing hemodialysis Patients who needed assistance for walking a month before hospitalization Dementia Pregnant, lactational woman, patients may be pregnant
Target sample size	46

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Kamiya
Organization	Kitasato University
Division name	Department of Rehabilitation, School of Allied Health Sciences
Zip code	252-0373
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	0427788111
Email	k-kamiya@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Kamiya
Organization	Kitasato University
Division name	Department of Rehabilitation, School of Allied Health Sciences
Zip code	252-0373
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	0427788111
Homepage URL
Email	k-kamiya@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science, and Technology (MEXT) of Japan.
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	Kitasato University Medical Ethics Organization(KMEO)
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel	0427788111
Email	rinri@med.kitasato-u.ac.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	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 12 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	No longer recruiting
Date of protocol fixation	2020 Year 03 Month 30 Day
Date of IRB	2021 Year 02 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 22 Day
Last follow-up date	2021 Year 06 Month 30 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 02 Month 12 Day
Last modified on	2022 Year 02 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048440