Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure

NCT ID: NCT04310072

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2019-11-20

Brief Summary

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type: DEVICE

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ploesteanu Rodica Lucia

OTHER

Sponsor Role: lead

Responsible Party

Ploesteanu Rodica Lucia

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mihai Berteanu

Role: PRINCIPAL_INVESTIGATOR

Elias Emergency Hospital

Locations

Spitalul Sfantul Pantelimon

Bucharest, București, Romania

Countries

Romania

References

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.

Reference Type: RESULT

PMID: 30140316 (View on PubMed)

Other Identifiers

SfantulPantelimon

Identifier Type: -

Identifier Source: org_study_id