Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure

Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure - Results of a Single-centre Randomized Trial

The investigators evaluated the effects of neuromuscular electrical stimulation (NMES) therapy on functional capacity and oxidative stress in patients hospitalized for an episode of acute heart failure (AHF). The NMES therapy was used on top of the conventional rehabilitation program. After randomization the investigators followed the patients by measuring the evolution of functional capacity, oxidative stress and adverse events.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Neuromuscular electrical stimulation

Detailed Description

In this program the investigators will include patients with acute heart failure (AHF) with left ventricular ejection fraction (LVEF) lower than 50%, admitted to our clinic.

Patients prior to being included in this research will sign an informed consent form in two samples, one remaining with the patient. This form will contain the study protocol, risks, potential benefits as well as assuring patients that personal data will be used strictly for research purposes. The inclusion and exclusion criteria are presented below. The patients will be randomized into two groups: neuromuscular electrostimulation (NMES) therapy and conventional rehabilitation or a conventional rehabilitation program alone (respiratory gymnastics and strength / endurance exercises in bed).

Patients will receive optimal medical therapy for AHF according to current management guidelines. Patients will complete different questionnaires (Kansas, Beck for Depression). In the first phase, patients will be given a form with questions regarding notions about heart failure and cardiovascular recovery to assess the level of knowledge about their disease.

All patients included will perform the following:

• Clinical evaluation
• ECG
• Biological samples (including NT pro BNP, CK, oxidized LDL plus standard samples)
• Cardiac ultrasound
• 6-minute walk test (6MWT) The duration of NMES therapy will be equal to the duration of hospitalization. At the time of discharge, all patients will undergo a 6MWT and biological samples (NT pro BNP and oxidized LDL) and receive a cardiac rehabilitation program that they will follow at home. They will be given advice on initiating and maintaining a healthy diet, as well as discontinuing smoking if this risk factor is identified.

There will be a telephone visit at 30 days and the investigator will note the vital status and rehospitalizations.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 021660
      • Spitalul Sfantul Pantelimon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with acute heart failure and a LVEF below 50% (echocardiography), admitted consecutively to the cardiology clinic of "Sfantul Pantelimon" Hospital, Bucharest

Exclusion Criteria:

• age under 18 years,
• acute coronary syndrome in the last month,
• recent myocardial revascularization (in the last 6 weeks),
• severe ischemic lesions at the level of the lower limbs,
• life-threatening arrhythmias,
• uncontrolled blood pressure,
• high-grade atrioventricular block,
• acute myocarditis,
• acute pericarditis,
• obstructive hypertrophic cardiomyopathy,
• acute systemic disease,
• deep vein thrombosis,
• severe uncorrected primary valvular disease,
• psychiatric disorders or marked cognitive impairment,
• active neoplastic disorders except basal or squamous cell carcinoma,
• other conditions that in the opinion of the investigator do not allow the participation to the study
• patient's refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neuromuscular electrical stimulation group; For patients who underwent NMES therapy, four electrodes (two 50/100 mm and two 50/50 mm, Compex Performance) were placed on the skin above the quadriceps muscle approximately 5 cm below the inguinal fold and 3 cm above the upper patella border. The electrical stimulation protocol consisted of electrical current at frequency of 10 Hz, 20 seconds stimulation time (time on) and 20 seconds resting time (time off) with variable intensity (until visible muscular contraction) for one hour per day until discharge (Compex).The NMES therapy was on top of conventional rehabilitation described below.	Device: Neuromuscular electrical stimulation; NMES therapy induces visible rhythmic and repeated muscle contractions without volitional effort from the patient by applying electrodes to the thigh and/or calf muscles.
No Intervention: Control group; The control group consisted of patients who performed daily active upper and lower limbs exercise in bed and in a stand position (3x10 repetitions, "somewhat hard" on the Borg scale).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the impact of NMES therapy applied during hospitalization on the functional capacity	The investigators will measure 6 minute walk test at the inclusion in the trial ans at the time of discharge	up to one month (30 days)
evaluate the impact of NMES therapy on oxidative stress	The investigator will measure oxidized LDL plasmatic levels at the inclusion in the trial ans at the time of discharge	up to one month (30 days)

Collaborators and Investigators

• Sponsor: Ploesteanu Rodica Lucia
• Investigators: Principal Investigator: Mihai Berteanu, Elias Emergency Hospital

Publications and helpful links

General Publications

• Ploesteanu RL, Nechita AC, Turcu D, Manolescu BN, Stamate SC, Berteanu M. Effects of neuromuscular electrical stimulation in patients with heart failure - review. J Med Life. 2018 Apr-Jun;11(2):107-118.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac rehabilitation; Nouromuscular electrical stimulation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SfantulPantelimon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the individual participant data can be available by email on request. This study is a part of a PhD thesis and a publication of the results will follow
• IPD Sharing Time Frame: The data is available from the present and 15 years from now
• IPD Sharing Access Criteria: all the data can be accessed by request on email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No