Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance

September 3, 2020 updated by: Andrey Bezdenezhnykh, Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kemerovo, Russian Federation, 650002
        • Recruiting
        • Research Institute for Complex Issues of Cardiovascular Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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)
Strength Assessment using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165)
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
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).
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)
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)
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)

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)
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)
number of days
From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)
Change in mechanical ventilation duration in EMS vs. controls
Time Frame: from the intubation to the extubation (expected an average of 7 hours)
number of minuits
from the intubation to the extubation (expected an average of 7 hours)
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)
Any complication wich required hospitalisation prolongation or additional procedures (eg pleural or pericardial punction, renal replacemen therapy, pneumonia, wound complications etc.) or death
From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (ACTUAL)

September 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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