UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043312
Receipt number 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 2022/02/13 14:55:57

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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 or person

Institute

Kitasato University

Institute

Department

Personal name



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

Value
https://center6.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