Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance

Heart Failure Clinical Trial

Official title:

Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04545268
• Other study ID #: 2020_4_19_32
• Status: Recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: December 2022

Study information

• Verified date: September 2020
• Source: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Contact: Andrey V Bezdenezhnykh, PhD
• Phone: +79132971069
• Email: andrew22014[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Intolerance
• Heart Failure
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Sarcopenia

Intervention

Device:
• 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).
• Transcutaneous electrical stimulation
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.

Locations

Country	Name	City	State
Russian Federation	Research Institute for Complex Issues of Cardiovascular Diseases	Kemerovo

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in length of stay (LOS) in ICU in EMS vs. controls.		From the end of cardiac procedure to the end of ICU stay (expected an average of 1 day)
Other	Change in length of stay (LOS) in postoperative department in EMS vs. controls	number of days	From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)
Other	Change in mechanical ventilation duration in EMS vs. controls	number of minuits	from the intubation to the extubation (expected an average of 7 hours)
Other	Rate of postoperative complication or death	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)
Primary	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)	From baseline to post EMS (at least 6th day after baseline)
Primary	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).	from post EMS (at least 6th day after baseline) to the end of hospitalisation (expected an average of 10 days)
Secondary	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	Baseline, post EMS (at least 6th day after baseline)
Secondary	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	Baseline, post EMS (at least 6th day after baseline)