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 2022/02/10 16:31:55

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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
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 Shinya Tanaka

Organization

Kitasato University

Division name

Graduate School of Medical Sciences

Zip code


Address

1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa

TEL

042-778-9081

Homepage URL


Email

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


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

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

2022 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021334


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name