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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020919
Receipt No. R000021325
Scientific Title Effects of acute phase intensive exercise training in patients with acute decompensated heart failure: The ACTIVE-ADHF Randomized Controlled Trial
Date of disclosure of the study information 2016/02/08
Last modified on 2016/06/19

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Basic information
Public title Effects of acute phase intensive exercise training in patients with acute decompensated heart failure: The ACTIVE-ADHF Randomized Controlled Trial
Acronym ACTIVE-ADHF Trial
Scientific Title Effects of acute phase intensive exercise training in patients with acute decompensated heart failure: The ACTIVE-ADHF Randomized Controlled Trial
Scientific Title:Acronym ACTIVE-ADHF Trial
Region
Japan

Condition
Condition Acute decompensated heart failure
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of acute phase intensive exercise training in patients with acute decompensated heart failure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Six-minute walk distance [Time Frame: Measured at baseline and 2 weeks]
Key secondary outcomes Lower extremity function, Physical activity, Cardiac and renal function, Quality of life [Time Frame: Measured at baseline and 2 weeks]

Mortality and rehospitalization rates (measured at 30 days and 3 months) [Time Frame: Measured as events occur during the lifespan of the trial]


Subgroup analysis (Statistical significance level of p-value for interaction: <0.1): Age >=65 years, Gender, LVEF >=50%, Six-minute walk distance >median value

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
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) Supervised exercise therapy for 30-60 minutes per day, 5-7 days per week
3) Instruction of physical activity
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who were hospitalized for acute exacerbation of heart failure
2) Aged 30 years or older
Key exclusion criteria 1) BNP < 100 pg/ml at admission
2) Cognitive dysfunction
3) Acute coronary syndrome
4) Significant myocardial ischemia during low-intensity exercise
5) Resting heart rate > 120/min
6) Acute infective endocarditis, myocarditis, and pericaritis
7) Presence of a recent hospitalization for heart failure (< 1 month)
8) Severe symptomatic aortic stenosis, mitral stenosis, and hypertrophic obstructive cardiomyopathy
9) Severe pulmonary hypertension
10) Intracardiac thrombus
11) Untreated life-threatening arrhythmia
12) Resting blood pressure > 180 mmHg
13) Ongoing orthopnea
14) Requiring high inotropic support
15) Patients with circulatory assist device
16) Patients with inadequate oxygenation
17) Patients with mechanical ventilation
18) History of aortic dissection, or presence of aortic aneurysm or aortic dissection
19) Patients with uncontrolled diabetes
20) Peripheral arterial disease (Fontain 3-4)
21) Recent embolism
22) Patients undergoing hemodialysis
23) Serum creatinine > 3.0 mg/dl
24) Severe anemia
25) Short life expectancy due to advanced disease other than heart failure
26) Patients who needed assistance for walking a month before hospitalization
27) Pregnant, lactational woman, patients may be pregnant
Target sample size 135

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Kamiya
Organization Kitasato University Hospital
Division name Rehabilitation
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL 042-778-8413
Email kamiken.pt@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Kamiya
Organization Kitasato University Hospital
Division name Rehabilitation
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL 042-778-8413
Homepage URL
Email kamiken.pt@gmail.com

Sponsor
Institute Kitasato University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kitasato University Medical Center, Kameda Medical Center
Name of secondary funder(s) Japanese Physical Therapy Association

IRB Contact (For public release)
Organization
Address
Tel
Email

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),北里大学メディカルセンター(埼玉県), 亀田総合病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 08 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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 07 Day
Last modified on
2016 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021325

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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