Clinical trial NCT04545268: Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
Official title: Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Exercise Intolerance
Heart Failure
Peripheral Artery Disease
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in strength test (Dynamometer) from baseline to post EMS in EMS vs. controls
timeFrame: From baseline to post EMS (at least 6th day after baseline)
measure: Change in strength test (Dynamometer) from post EMS to pre-discharge in EMS vs. controls
timeFrame: from post EMS (at least 6th day after baseline) to the end of hospitalisation (expected an average of 10 days)
Secondary outcomes:
measure: Change in 6-minute walk test distance from baseline to post EMS in EMS vs. controls
timeFrame: Baseline, post EMS (at least 6th day after baseline)
measure: Change in 6-minute walk test distance from post EMS to pre-discharge in EMS vs. controls
timeFrame: Baseline, post EMS (at least 6th day after baseline)
Other outcomes:
measure: Change in length of stay (LOS) in ICU in EMS vs. controls.
timeFrame: From the end of cardiac procedure to the end of ICU stay (expected an average of 1 day)
measure: Change in length of stay (LOS) in postoperative department in EMS vs. controls
timeFrame: From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)
measure: Change in mechanical ventilation duration in EMS vs. controls
timeFrame: from the intubation to the extubation (expected an average of 7 hours)
measure: Rate of postoperative complication or death
timeFrame: From the end of cardiac procedure to the end of hospitalisation (expected an average of 10 days)
Locations:
city: Kemerovo
country: Russian Federation
facility: Research Institute for Complex Issues of Cardiovascular Diseases
Study officials:
affiliation: Research Institute for Complex Issues of Cardiovacular Diseases
name: Andrey V Bezdenezhnykh, PhD
role: PRINCIPAL_INVESTIGATOR
References: