- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545268
Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kemerovo, Russian Federation, 650002
- Recruiting
- Research Institute for Complex Issues of Cardiovascular Diseases
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Contact:
- Andrew V Bezdenezhnykh, PhD
- Phone Number: +79132971069
- Email: andrew22014@mail.ru
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: Control group
|
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.
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EXPERIMENTAL: NMES group
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Strength Assessment using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165)
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From baseline to post EMS (at least 6th day after baseline)
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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)
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Strength Assessment will be done using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165).
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from post EMS (at least 6th day after baseline) to the end of hospitalisation (expected an average of 10 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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
|
Baseline, post EMS (at least 6th day after baseline)
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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)
|
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
|
Baseline, post EMS (at least 6th day after baseline)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in length of stay (LOS) in ICU in EMS vs. controls.
Time Frame: From the end of cardiac procedure to the end of ICU stay (expected an average of 1 day)
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From the end of cardiac procedure to the end of ICU stay (expected an average of 1 day)
|
|
Change in length of stay (LOS) in postoperative department in EMS vs. controls
Time Frame: From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)
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number of days
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From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)
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Change in mechanical ventilation duration in EMS vs. controls
Time Frame: from the intubation to the extubation (expected an average of 7 hours)
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number of minuits
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from the intubation to the extubation (expected an average of 7 hours)
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Rate of postoperative complication or death
Time Frame: From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)
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Any complication wich required hospitalisation prolongation or additional procedures (eg pleural or pericardial punction, renal replacemen therapy, pneumonia, wound complications etc.) or death
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From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurologic Manifestations
- Atherosclerosis
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Peripheral Vascular Diseases
- Peripheral Arterial Disease
- Sarcopenia
Other Study ID Numbers
- 2020_4_19_32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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