UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020919 |
|---|---|
| Receipt number | 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 | 2025/02/15 02:28:52 |
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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 | Kentaro |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University Hospital
Division name
Rehabilitation
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
042-778-8413
kamiken.pt@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University Hospital
Division name
Rehabilitation
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
042-778-8413
Homepage URL
kamiken.pt@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Self funding
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
Clinical Research Review Board of the Kitasato Institute
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8111
rinri-n@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)，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
https://doi.org/10.1016/j.jchf.2024.11.006
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jchf.2024.11.006
Number of participants that the trial has enrolled
91
Results
In patients with acute decompensated heart failure without physical frailty, in-hospital exercise-based cardiac rehabilitation led to significant improvements in 6-minute walk distance at 2 weeks after randomization without compromising safety.
Results date posted
| 2025 | Year | 02 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of patients in the exercise group was 69.8 years, with 79.6% male,compared with 68.4 years and 71.0% male in the control group. Similarly, the mean left ventricular ejection fraction was 38.1% in the exercise group and 36.4% in the control group, with comparable rates of hospitalization for HF in the past year (31.5% vs 32.3%).
Participant flow
Ninety one patients were enrolled, and 80 were included in the final analysis.
Adverse events
There were no adverse events.
Outcome measures
The changes in physical function based on 6-minute walking distance, quadriceps isometric strength, handgrip strength, SPPB score, and usual gait speed and cognitive function assessed using the Digit Symbol Substitution Test between baseline and 2 weeks were determined.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021325
