SarcopeniaNCT04522609
Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant
A study testing Neuromuscular electrical stimulation (NMES) in people with Sarcopenia and Heart Failure, Systolic, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
Trial summary
Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sarcopenia, Heart Failure, Systolic
- What is being tested?
- Neuromuscular electrical stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2020to Nov 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage heart disease, listed for heart transplantation
- already received standard treatment based on patient condition
- are receiving guideline recommended pharmacologic therapy
- able to follow protocol procedures
- assigned the informed consent
- do not regularly exercise (10 minutes or more a day of exercise most days of the week for the past week).
Who cannot join
- UNOS 1a or 1b patients
- already receive NMES at femoris area in last 6 weeks before admission
- Patients, who have undertaken cardiac rehab within the 12 months prior to enrollment
- Cognitive, orthopedic or neurological disorders or other impairment which prevents accurate application of intervention or inability to provide informed consent
- End Stage Renal Disease
- Uncontrolled arrhythmia's or 3rd degree AV heart block
- Those with wounds over area of proper placement of electrodes
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, 650002
Andrey V Bezdenezhnykh, PhD, +73842644461, andrew22014@mail.ru
About this study
Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. It is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. In patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of heart failure management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity.
In this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.
- Conditions
- Sarcopenia, Heart Failure, Systolic
- Being tested
- Neuromuscular electrical stimulation (NMES)
- Keywords
- sarcopenia, neuromuscular electric stimulation, skeletal muscles, heart failure, heart transplantation listing
- Medical subject headings
- Sarcopenia, Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation (NMES)Device
NMES will carried out with four-channel myostimulator "Beurer EM80" (Germany). Self-adhesive electrodes locates above the quadriceps, the duration of the NMES session was 60 minutes, including 5-minute periods of warm-up and warm-down. Throughout the series, rectangular pulses with a frequency of 45 Hz will modulate. As a result, tonic contraction of these muscles will induce for 12 seconds, followed by a pause of 5 seconds. The amplitude of electrical exposure will select separately for each of the four channels until good muscle contraction (visually or by palpation) without pain. Electrical stimulation: 5-6 session per week, for 12 weeks, with 60-minuite session.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Guideline recommended pharmacologic therapy |
| NMES group | Experimental | standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES) Receives: Device: Neuromuscular electrical stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls
Strength Assessment will be done using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165)
Measured: Baseline, 12 weeks after baseline
Change in 6-minute walk test distance from baseline to 12-weeks post EMS in EMS vs. controls
Participants will be instructed to move as quickly as they feel safe and comfortable over the 50-meter course for 6 minutes. As per the protocol, participants will be allowed to stop and rest if necessary.
Measured: Baseline, 12 weeks after baseline
Secondary outcomes (2)
Change in right ventricle diastolic function from baseline to 12-weeks post EMS in EMS vs. controls
Measured: Baseline, 12 weeks after baseline
Change in peak oxygen consumption, measured by spiroergometry from baseline to 12 weeks post EMS in EMS vs. controls
Measured: Baseline, 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blinded, randomized longitudinal study design to determine if NMES will increase muscle mass and strength and improve exercise capacity and right-ventricle diastolic function in patients with advanced HF. Patients will be randomized to either intervention that includes NMES or to a control group. In order to ensure that the two groups are comparable between treatment and control, the participants will be randomized according to gender. Randomization via minimization will be used in order to avoid an unbalanced number of women in the two comparison groups due to chance. A file of the computer-generated random assignments will be kept.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrey Bezdenezhnykh, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Investigators
- Andrey V Bezdenezhnykh, PhD, Principal investigator, Research Institute for Complex Issues of Cardiovacular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522609
- Sponsor's protocol ID
- 2020_4_19_31
- Status last verified
- Sep 2020
- First submitted
- 18 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant
- ClinicalTrials.gov ID
- NCT04522609
- Acronym / sponsor ID
- 2020_4_19_31
- Conditions
- Sarcopenia, Heart Failure, Systolic
- Keywords
- sarcopenia, neuromuscular electric stimulation, skeletal muscles, heart failure, heart transplantation listing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, RussiaUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 21 Aug 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.
Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. It is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. In patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of heart failure management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity.
In this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-blinded, randomized longitudinal study design to determine if NMES will increase muscle mass and strength and improve exercise capacity and right-ventricle diastolic function in patients with advanced HF. Patients will be randomized to either intervention that includes NMES or to a control group. In order to ensure that the two groups are comparable between treatment and control, the participants will be randomized according to gender. Randomization via minimization will be used in order to avoid an unbalanced number of women in the two comparison groups due to chance. A file of the computer-generated random assignments will be kept.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Guideline recommended pharmacologic therapy |
| NMES group | Experimental | Device: Neuromuscular electrical stimulation (NMES)standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with end-stage heart disease, listed for heart transplantation
- already received standard treatment based on patient condition
- are receiving guideline recommended pharmacologic therapy
- able to follow protocol procedures
- assigned the informed consent
Key exclusion criteria (7 listed)
- UNOS 1a or 1b patients
- already receive NMES at femoris area in last 6 weeks before admission
- Patients, who have undertaken cardiac rehab within the 12 months prior to enrollment
- Cognitive, orthopedic or neurological disorders or other impairment which prevents accurate application of intervention or inability to provide informed consent
- End Stage Renal Disease
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 stimulation (NMES)NMES will carried out with four-channel myostimulator "Beurer EM80" (Germany). Self-adhesive electrodes locates above the quadriceps, the duration of the NMES session was 60 minutes, including 5-minute periods of warm-up and warm-down. Throughout the series, rectangular pulses with a frequency of 45 Hz will modulate. As a result, tonic contraction of these muscles will induce for 12 seconds, followed by a pause of 5 seconds. The amplitude of electrical exposure will select separately for each of the four channels until good muscle contraction (visually or by palpation) without pain. Electrical stimulation: 5-6 session per week, for 12 weeks, with 60-minuite session. | Device | NMES group |
Primary outcome
Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls
Time frame: Baseline, 12 weeks after baseline
Strength Assessment will be done using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165)
Change in 6-minute walk test distance from baseline to 12-weeks post EMS in EMS vs. controls
Time frame: Baseline, 12 weeks after baseline
Participants will be instructed to move as quickly as they feel safe and comfortable over the 50-meter course for 6 minutes. As per the protocol, participants will be allowed to stop and rest if necessary.
2 secondary outcomes
Change in right ventricle diastolic function from baseline to 12-weeks post EMS in EMS vs. controls
Time frame: Baseline, 12 weeks after baseline
Change in peak oxygen consumption, measured by spiroergometry from baseline to 12 weeks post EMS in EMS vs. controls
Time frame: Baseline, 12 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Andrey V Bezdenezhnykh, PhD principal investigator
Research Institute for Complex Issues of Cardiovacular Diseases
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 (NMES) in people with Sarcopenia and Heart Failure, Systolic, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Sep 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrey V Bezdenezhnykh, PhD (+79132971069, andrew22014@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls (time frame: Baseline, 12 weeks after baseline). 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?
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 10 Sep 2020.