Clinical trial NCT04522609: Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant
Official title: Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Heart Failure, Systolic
Keywords: sarcopenia
neuromuscular electric stimulation
skeletal muscles
heart failure
heart transplantation listing
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blinded, randomized longitudinal study design to determine if NMES will increase muscle mass and strength and improve exercise capacity and right-ventricle diastolic function in patients with advanced HF. Patients will be randomized to either intervention that includes NMES or to a control group. In order to ensure that the two groups are comparable between treatment and control, 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: PREVENTION

Brief summary: Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. It is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. In patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of heart failure management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity.

In this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.


Eligibility criteria: Inclusion Criteria:

* Patients with end-stage heart disease, listed for heart transplantation
* already received standard treatment based on patient condition
* are receiving guideline recommended pharmacologic therapy
* 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:

* UNOS 1a or 1b patients
* 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 12-weeks post EMS in EMS vs. controls
timeFrame: Baseline, 12 weeks after baseline
measure: Change in 6-minute walk test distance from baseline to 12-weeks post EMS in EMS vs. controls
timeFrame: Baseline, 12 weeks after baseline
Secondary outcomes:
measure: Change in right ventricle diastolic function from baseline to 12-weeks post EMS in EMS vs. controls
timeFrame: Baseline, 12 weeks after baseline
measure: Change in peak oxygen consumption, measured by spiroergometry from baseline to 12 weeks post EMS in EMS vs. controls
timeFrame: Baseline, 12 weeks after baseline
Other outcomes:
measure: Patients survival in EMS vs. controls
timeFrame: 12 weeks after baseline
measure: Change in muscle rectus femoris crossectional area assessed by ultrasound from baseline to 12 weeks post EMSin EMS vs. controls
timeFrame: Baseline, 12 weeks after baseline
measure: Change in muscle rectus femoris crossectional area assessed by ultrasound from baseline to 12 weeks post EMSin EMS vs. controls
timeFrame: Time Frame: Baseline, 12 weeks after baseline
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: