UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019551 |
|---|---|
| Receipt number | R000021334 |
| Scientific Title | Effects of acute phase intensive electrical muscle stimulation in frail elderly patients with acute decompensated heart failure: The ACTIVE-EMS Randomized Controlled Trial |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2025/02/15 02:01:52 |
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Basic information
Public title
Effects of acute phase intensive electrical muscle stimulation in frail elderly patients with acute decompensated heart failure: The ACTIVE-EMS Randomized Controlled Trial
Acronym
ACTIVE-EMS Trial
Scientific Title
Effects of acute phase intensive electrical muscle stimulation in frail elderly patients with acute decompensated heart failure: The ACTIVE-EMS Randomized Controlled Trial
Scientific Title:Acronym
ACTIVE-EMS Trial
Region
| Japan |
Condition
Condition
Frail elderly patients with 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 electrical muscle stimulation in frail elderly patients with acute decompensated heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quadriceps Strength [Time Frame: Measured at baseline and 2 weeks]
Key secondary outcomes
Physical function, Six-minute walk distance, Cognitive function, Cardiac and renal function [Time Frame: Measured at baseline and 2 weeks]
Subgroup analysis (Statistical significance level of p-value for interaction: <0.1): Gender, LVEF >=50%, Quadriceps strength >median value, six-minute walk distance >median value, Age >=85 years
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) Early rehabilitation program
2) Electrical muscle stimulation for 30-40 minutes per day, 5 days per week, 2 weeks
Interventions/Control_2
1) Early rehabilitation program
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
| 75 | 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 75 years or older
3) Frail patients (Short Physical Performance Battery score 4-9)
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
80
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 | Shinya |
| Middle name | |
| Last name | Tanaka |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
042-778-9081
Homepage URL
tanashin.pt@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Heart Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kitasato University Medical Center, Kameda Medical Center
Name of secondary funder(s)
Japan Society for the Promotion of Science
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
| 2015 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
https://doi.org/10.1002/clc.22845
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/eurjpc/zwac022
Number of participants that the trial has enrolled
39
Results
The inclusion of EMS therapy in addition to exercise-based early cardiac rehabilitation yielded significantly improved lower extremity function without adverse events in frail patients aged 75 years and older with acute heart failure
Results date posted
| 2022 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 08 | Day |
Baseline Characteristics
The study population had a mean age of 82.9 years, 54.8% were women, mean LVEF was 43.4%, and 32.3% had preserved ejection fraction. The rates of hypertension, renal failure, and anemia in the study population were high. The patients had severe impairment of physical function and at least mild cognitive dysfunction at baseline.
Participant flow
Thirty nine patients were enrolled by the planned study completion date, and 31 were included in the final analysis.
Adverse events
There were no adverse events.
Outcome measures
The changes in physical function based on quadriceps isometric strength, handgrip strength, SPPB score, usual gait speed, and 6-minute walking distance 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
| 2015 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021334
