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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043312
Receipt No. R000048440
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.
Date of disclosure of the study information 2021/02/12
Last modified on 2021/02/19

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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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 15 Day
Last follow-up date
2021 Year 04 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
2021 Year 02 Month 19 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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