Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure

NCT04310072 | Completed

• 1 other identifier: SfantulPantelimon
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Cardiac rehabilitation; Nouromuscular electrical stimulation

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

neuromuscular electrical stimulation group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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).

Interventions

Neuromuscular electrical stimulation 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.

neuromuscular electrical stimulation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ploesteanu Rodica Lucia: lead

Study Sites (1)

Spitalul Sfantul Pantelimon

Bucharest, București, 021660, Romania

Location

Related Publications (1)

• 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.

  PMID: 30140316 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mihai Berteanu

  Elias Emergency Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After the patients were evaluated for inclusion in the study and after signing the informed consent form, they were randomized using the website www.randomization.com (1 complete randomized block). Considering our intervention protocol, it was not possible to blind the patients and/or the investigator who performed the electrostimulation. However, the other investigators who conducted the 6MWT and performed the randomization were blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: The study team conducted a prospective randomized study to investigate the effects of NMES versus standard therapy on a hospitalized population with AHF. After the patients with AHF were stabilized they were included in the trial and were randomized by a blinded investigator to control group or NMES therapy. At the time of enrollment, patients were clinically evaluated and their associated comorbidities and drug therapy were noted. ECG, echocardiography, 6-minute walk test (6MWT) were performed and laboratory samples were collected including oxidized LDL, NT- proBNP, CK, uric acid, lipid profile and PCR. At the time of discharge, all patients underwent a 6MWT and laboratory samples such as oxidized LDL and NT-proBNP were collected again. During the hospitalization period we monitored any adverse events and tolerance to NMES therapy. At the time of inclusion in the study, patients signed an informed consent form in two copies, one remaining with the patient.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 17, 2020
• Study Start: September 10, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data is available from the present and 15 years from now
• Access Criteria: all the data can be accessed by request on email

Locations

RO (1)