Heart FailureNCT04310072
Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure
A study testing Neuromuscular electrical stimulation in people with Heart Failure, run by Ploesteanu Rodica Lucia at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRomania
- Study dates
- 10 Sep 2019to 20 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute heart failure and a LVEF below 50% (echocardiography), admitted consecutively to the cardiology clinic of "Sfantul Pantelimon" Hospital, Bucharest
Who cannot join
- 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,
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Neuromuscular electrical stimulation
- Keywords
- Cardiac rehabilitation, Nouromuscular electrical stimulation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to one month (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start10 Sep 2019
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ploesteanu Rodica Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ploesteanu Rodica Lucia, Sfantul Pantelimon Emergency Hospital
- Investigators
- Mihai Berteanu, Principal investigator, Elias Emergency Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310072
- Sponsor's protocol ID
- SfantulPantelimon
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 30140316
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure - Results of a Single-centre Randomized Trial
- ClinicalTrials.gov ID
- NCT04310072
- Acronym / sponsor ID
- SfantulPantelimon
- Conditions
- Heart Failure
- Keywords
- Cardiac rehabilitation, Nouromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ploesteanu Rodica LuciaUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| neuromuscular electrical stimulation group | Experimental | Device: Neuromuscular electrical stimulationFor 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with acute heart failure and a LVEF below 50% (echocardiography), admitted consecutively to the cardiology clinic of "Sfantul Pantelimon" Hospital, Bucharest
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationNMES therapy induces visible rhythmic and repeated muscle contractions without volitional effort from the patient by applying electrodes to the thigh and/or calf muscles. | Device | neuromuscular electrical stimulation group |
Primary outcome
evaluate the impact of NMES therapy applied during hospitalization on the functional capacity
Time frame: up to one month (30 days)
The investigators will measure 6 minute walk test at the inclusion in the trial ans at the time of discharge
evaluate the impact of NMES therapy on oxidative stress
Time frame: up to one month (30 days)
The investigator will measure oxidized LDL plasmatic levels at the inclusion in the trial ans at the time of discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Results publication: PubMed 30140316Ploesteanu 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihai Berteanu principal investigator
Elias Emergency Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation in people with Heart Failure, run by Ploesteanu Rodica Lucia at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the impact of NMES therapy applied during hospitalization on the functional capacity (time frame: up to one month (30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.