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临床试验/NCT03615469
NCT03615469终止不适用

Building Strength Through Rehabilitation for Heart Failure Patients

Indiana University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
2
主要终点
Change in 6 Minute Walk Test

研究概览

简要总结

In the U.S., 5.7 million people have heart failure (HF), 915,000 new cases are diagnosed each year, and both incidence and prevalence are increasing due to the aging of the population and to better survival from ischemic heart disease. A hallmark of HF, is poor functional status that, characteristically, deteriorates as the condition progresses, negatively affecting patients' quality of life. Poor functional status is associated with increased risk of hospitalization for exacerbations of HF and with increased mortality. 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 HF 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 HF symptoms and hospitalizations in patients with HF. 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 (NMES) to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance. NMES has been shown to improve muscle strength, exercise capacity and quality of life, in samples less than 20 of male patients with HF. Larger sample studies are needed to demonstrate efficacy of this practice to jump start patients' abilities to benefit from formalized exercise program. The purpose of this double blinded, randomized, controlled, longitudinal study is to determine if NMES will increase muscle mass and strength, decrease sedentary time, and improve HF symptoms and exercise capacity, thus improving quality of life in patients with HF. It is hypothesized that with this increase in muscle mass, patients will improve overall exercise tolerance and capacity. In addition, after the intervention patients will be better able to tolerate an exercise program thus improving adherence to exercise recommendations. After 6 weeks of intervention, patients will be encouraged to participate in a formalized exercise program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The PI will collect baseline data before the participant is randomized. The intervention/sham will be set-up by the RA and will be collected after the PI leaves the department so those collecting data will not know which group the participant has been/will be participating in. The RA 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. Once trained, participants will be contacted via phone weekly by the RA who initially trained them (in order to maintain blinding). The RA applying the intervention will not have any part in the data collection of the rest of the measurements (other than adherence, tolerance and problems with equipment).

入排标准

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

入选标准

  • Adult patients who have recently been hospitalized for heart failure
  • live at home
  • are receiving guideline recommended pharmacologic therapy
  • 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

  • Patients, who have undertaken cardiac rehab within the 12 months prior to enrollment
  • Cognitive or other impairment which prevents accurate application of intervention or inability to provide informed consent
  • End Stage Renal Disease or receiving mechanical ventilation
  • Receiving non-approved FDA-investigational agents or devices,
  • Has received a heart transplant, a destination Ventricular Assist Device (LVAD), pacemaker, or implantable cardiac device
  • previously used NMES (Neuromuscular electrical stimulation) or TENS (Transcutaneous electrical nerve stimulation)
  • Uncontrolled arrhythmia's or 3 degree AV heart block
  • are unable to correctly apply and operate the device even after instruction
  • Those with wounds over area of proper placement of electrodes
  • Those who are unable to speak and write English.

结局指标

主要结局

Change in 6 Minute Walk Test

时间窗: From Baseline to 5-6 months

The 6-min walk test (6MWT) estimates the person's ability to perform everyday activities by measuring the distance walked in a set time period. It will be used to measure exercise capacity, specific aim 2. Participants will be allowed use of an assistive device and will be instructed to move as quickly as they feel safe and comfortable over the 100-meter course for 6 minutes. As per the protocol, participants will be allowed to stop and rest if necessary. This test is recommended by the American Thoracic Society for patients with moderate to severe heart or lung disease.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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