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临床试验/NCT04522609
NCT04522609Unknown不适用

Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

Research Institute for Complex Problems of Cardiovascular Diseases, Russia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The Investigator will collect baseline data before the participant is randomized. The intervention will be set-up by the Investigator.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls

时间窗: Baseline, 12 weeks after baseline

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

Change in 6-minute walk test distance from baseline to 12-weeks post EMS in EMS vs. controls

时间窗: Baseline, 12 weeks 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.

次要结局

  • Change in right ventricle diastolic function from baseline to 12-weeks post EMS in EMS vs. controls(Baseline, 12 weeks after baseline)
  • Change in peak oxygen consumption, measured by spiroergometry from baseline to 12 weeks post EMS in EMS vs. controls(Baseline, 12 weeks after baseline)

研究者

发起方
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrey Bezdenezhnykh

Senior Researcher of Comorbidity in Cardiovascular Diseases Laboratory, PhD

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

研究点 (2)

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