SarcopeniaNCT04545268
Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
A study testing Neuromuscular electrical stimulation (NMES) and Transcutaneous electrical stimulation in people with Sarcopenia and Exercise Intolerance, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
Trial summary
Among patients awaiting cardiac surgery, a significant proportion are patients with severe angina, heart failure (HF) and peripheral atherosclerosis. These factors are predictors of an unfavorable near and long-term prognosis after open cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Sarcopenia, Exercise Intolerance, Heart Failure
- What is being tested?
- Neuromuscular electrical stimulation (NMES) and Transcutaneous electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2020to Dec 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients awaiting for elective cardiovascular procedure (CABG, valvular or thoracic aorta) unable to walk more than 300 meters during six-minuite walking test due to angina, dyspnea or limb ischemia
- no weakness of lower limbs
- stable hemodynamic, already received standard treatment based on patient condition
- 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
- urgent indications for surgery or counterindication for elective operation
- 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
Andrew V Bezdenezhnykh, PhD, +79132971069, andrew22014@mail.ru
About this study
Among patients awaiting cardiac surgery, a significant proportion are patients with severe angina, heart failure (HF) and peripheral atherosclerosis. These factors are predictors of an unfavorable near and long-term prognosis after open cardiac surgery. It is known that the restriction of motor activity in patients with peripheral atherosclerosis and HF leads to loss of muscle mass, as well as to a decrease in its strength and endurance: secondary (disuse) sarcopenia is formed. In patients with peripheral atherosclerosis and HF, the low functional status of skeletal muscles is associated with a poor prognosis, regardless of gender, age, and concomitant coronary artery disease. A number of studies have shown that the deterioration of muscle status before abdominal, orthopedic and vascular surgery interferes with the close results of surgery, increases the number of complications, the length of ICU and in-hospital stay. Thus, sarcopenia serves as an additional factor worsening the prognosis. Therefore, efforts aimed at improving the functional status in patients planning an open cardiosurgical surgery seem to be very justified.
Standard preoperative management of patients includes the identification and correction of comorbidities and the optimal medical treatment. The idea of "rehabilitation" means an additional improvement in the functional capabilities of patients awaiting surgery. Prevention includes outpatient outreach and educational work by nurses, as well as preoperative physical exercises. For this, multi-level training is used: respiratory exercises for the patients with the most severe illness, free movements of the limbs without load, or bike or treadmill training with increasing load for tolerable patients.
Read more
However, adequate physical rehabilitation is difficult particularly on an outpatient basis. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity due to angina, chronic lower limb ischemia and heart failure symptoms.
In this study, the investigators propose to use neuromuscular electrical stimulation (NMES) to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.
- Being tested
- Neuromuscular electrical stimulation (NMES), Transcutaneous electrical stimulation
- Medical subject headings
- Sarcopenia, Heart Failure, Peripheral Arterial Disease
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 heating and hitch. 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 will start from the second day after the admission to preoperative department and will carried out during the entire preoperative period (about 10 days).
Transcutaneous electrical stimulationDevice
For the Sham group, electrodes will follow the same site, but the stimulation will only increase to an intermittent tingling sensation with the machine setting on TENS instead of NMES which is not enough to make noticeable changes in muscle mass or circulation. Intensity settings will not change over time.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Not described Receives: Device: Transcutaneous electrical stimulation |
| NMES group | Experimental | Not described 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 post EMS in EMS vs. controls
Strength Assessment using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165)
Measured: From baseline to post EMS (at least 6th day after baseline)
Change in strength test (Dynamometer) from post EMS to pre-discharge in EMS vs. controls
Strength Assessment will be done using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165).
Measured: from post EMS (at least 6th day after baseline) to the end of hospitalisation (expected an average of 10 days)
Secondary outcomes (2)
Change in 6-minute walk test distance from baseline to 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, post EMS (at least 6th day after baseline)
Change in 6-minute walk test distance from post EMS to pre-discharge 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, post EMS (at least 6th day after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blinded, randomized controlled longitudinal study design to determine if NMES will increase muscle mass and strength and improve exercise capacity thus improving likelihood of engagement with a structured exercise program. Patients will be randomized to either intervention that includes NMES or to a sham control group. In order to ensure that the two groups are comparable between treatment and sham interventions, 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
- NCT04545268
- Sponsor's protocol ID
- 2020_4_19_32
- Status last verified
- Sep 2020
- First submitted
- 18 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- 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
- Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
- ClinicalTrials.gov ID
- NCT04545268
- Acronym / sponsor ID
- 2020_4_19_32
- 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
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Sep 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.
Among patients awaiting cardiac surgery, a significant proportion are patients with severe angina, heart failure (HF) and peripheral atherosclerosis. These factors are predictors of an unfavorable near and long-term prognosis after open cardiac surgery. It is known that the restriction of motor activity in patients with peripheral atherosclerosis and HF leads to loss of muscle mass, as well as to a decrease in its strength and endurance: secondary (disuse) sarcopenia is formed. In patients with peripheral atherosclerosis and HF, the low functional status of skeletal muscles is associated with a poor prognosis, regardless of gender, age, and concomitant coronary artery disease. A number of studies have shown that the deterioration of muscle status before abdominal, orthopedic and vascular surgery interferes with the close results of surgery, increases the number of complications, the length of ICU and in-hospital stay. Thus, sarcopenia serves as an additional factor worsening the prognosis. Therefore, efforts aimed at improving the functional status in patients planning an open cardiosurgical surgery seem to be very justified.
Standard preoperative management of patients includes the identification and correction of comorbidities and the optimal medical treatment. The idea of "rehabilitation" means an additional improvement in the functional capabilities of patients awaiting surgery. Prevention includes outpatient outreach and educational work by nurses, as well as preoperative physical exercises. For this, multi-level training is used: respiratory exercises for the patients with the most severe illness, free movements of the limbs without load, or bike or treadmill training with increasing load for tolerable patients.
However, adequate physical rehabilitation is difficult particularly on an outpatient basis. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity due to angina, chronic lower limb ischemia and heart failure symptoms.
In this study, the investigators propose to use neuromuscular electrical stimulation (NMES) to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-blinded, randomized controlled longitudinal study design to determine if NMES will increase muscle mass and strength and improve exercise capacity thus improving likelihood of engagement with a structured exercise program. Patients will be randomized to either intervention that includes NMES or to a sham control group. In order to ensure that the two groups are comparable between treatment and sham interventions, 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 | Sham comparator | Device: Transcutaneous electrical stimulation |
| NMES group | Experimental | Device: Neuromuscular electrical stimulation (NMES) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients awaiting for elective cardiovascular procedure (CABG, valvular or thoracic aorta) unable to walk more than 300 meters during six-minuite walking test due to angina, dyspnea or limb ischemia
- no weakness of lower limbs
- stable hemodynamic, already received standard treatment based on patient condition
- able to follow protocol procedures
- assigned the informed consent
Key exclusion criteria (7 listed)
- urgent indications for surgery or counterindication for elective operation
- 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 heating and hitch. 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 will start from the second day after the admission to preoperative department and will carried out during the entire preoperative period (about 10 days). | Device | NMES group |
| Transcutaneous electrical stimulationFor the Sham group, electrodes will follow the same site, but the stimulation will only increase to an intermittent tingling sensation with the machine setting on TENS instead of NMES which is not enough to make noticeable changes in muscle mass or circulation. Intensity settings will not change over time. | Device | Control group |
Primary outcome
Change in strength test (Dynamometer) from baseline to post EMS in EMS vs. controls
Time frame: From baseline to post EMS (at least 6th day after baseline)
Strength Assessment using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165)
Change in strength test (Dynamometer) from post EMS to pre-discharge in EMS vs. controls
Time frame: from post EMS (at least 6th day after baseline) to the end of hospitalisation (expected an average of 10 days)
Strength Assessment will be done using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165).
2 secondary outcomes
Change in 6-minute walk test distance from baseline to post EMS in EMS vs. controls
Time frame: Baseline, post EMS (at least 6th day after baseline)
Change in 6-minute walk test distance from post EMS to pre-discharge in EMS vs. controls
Time frame: Baseline, post EMS (at least 6th day 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) and Transcutaneous electrical stimulation in people with Sarcopenia and Exercise Intolerance, 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. Some participants in this study may receive a placebo. 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 post EMS in EMS vs. controls (time frame: From baseline to post EMS (at least 6th day 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.