UMIN-CTR Clinical Trial

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

Acute decompensated heart failure

Classification by specialty

Cardiology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Kitasato University Hospital

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Kitasato University Medical Center, Kameda Medical Center

Name of secondary funder(s)

Japanese Physical Therapy Association

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2016

Year

02

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

02

Month

07

Day

Last modified on

2016

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021325