Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545268
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Andrey Bezdenezhnykh, Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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.


Condition or disease Intervention/treatment Phase
Sarcopenia Exercise Intolerance Heart Failure Peripheral Artery Disease Device: Neuromuscular electrical stimulation (NMES) Device: Transcutaneous electrical stimulation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: The Investigator will collect baseline data before the participant is randomized. The intervention/sham will be set-up by the Investigator. The Investigator who is trained in both NMES and Sham intervention will then look at the randomization schedule and set up and train the participants on equipment use
Primary Purpose: Treatment
Official Title: Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Control group Device: 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.

Experimental: NMES group 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).




Primary Outcome Measures :
  1. 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)

  2. 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).


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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) ]
  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545268


Contacts
Layout table for location contacts
Contact: Andrey V Bezdenezhnykh, PhD +79132971069 andrew22014@mail.ru

Locations
Layout table for location information
Russian Federation
Research Institute for Complex Issues of Cardiovascular Diseases Recruiting
Kemerovo, Russian Federation, 650002
Contact: Andrew V Bezdenezhnykh, PhD    +79132971069    andrew22014@mail.ru   
Sponsors and Collaborators
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Investigators
Layout table for investigator information
Principal Investigator: Andrey V Bezdenezhnykh, PhD Research Institute for Complex Issues of Cardiovacular Diseases
Layout table for additonal information
Responsible Party: Andrey Bezdenezhnykh, Senior Researcher of Comorbidity in Cardiovascular Diseases Laboratory, PhD, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
ClinicalTrials.gov Identifier: NCT04545268    
Other Study ID Numbers: 2020_4_19_32
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Peripheral Arterial Disease
Cardiovascular Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Peripheral Vascular Diseases