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临床试验/NCT06576297
NCT06576297已完成不适用

Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Safety of a 12-week home-based IMT program.

研究概览

简要总结

In a randomized controlled trial, to study the utility of inspiratory muscle training (IMT) to improve functional outcomes in adults aged ≥70 years with heart failure (HF) who have been referred to palliative care for end-stage HF management.

  • The study team hypothesize that older HF patients will be able to use IMT safely, reliably, and effectively in a 12-week home-based training regimen.
  • The study team hypothesize that physical function (sit to stand, gait speed, grip strength), respiratory/pulmonary function, self-efficacy, fatigue and quality of life will increase among older HF patients randomized IMT versus those randomized to usual care.

详细描述

Heart failure (both HF with reduced ejection fraction [HFrEF] and HF with preserved ejection fraction [HFpEF]) are on the rise in our aging population. Exercise intolerance is a leading detriment of the disease. While it is understood that exercise training is beneficial, strategies to achieve exercise training in this population are inherently limited, particularly as the issues that contribute to HF pathophysiology (i.e., advanced age, frailty, multimorbidity) also predispose to sedentariness, weakening, frailty, sarcopenia, fatigue, and cognitive impairment. Physical activity and particularly exercise training may be hard to initiate and sustain especially because it is encumbered by limitations. Home-based exercise training strategies are conceptually appealing in respect to practicality of access, but the associated issues of monitoring for effective and safe exercise, motivation, and tracking of training are all difficult to achieve in a home-based format. Furthermore, many older adults lack suitable space or resources for traditional home-based exercise training.

IMT with the PrO2™ device responds to these challenges with a novel approach to achieve physiologically robust training effect (strength training of the diaphragm) in a way that mitigates breathlessness and augments multiple indices of function in a way that is practical and safe, even at home. The electronic dimensions of the device also enable embedded trackability and behavioral prompts. Overall, this is a novel approach to a common, familiar problem, and it responds directly to a well-known problem of dyspnea, sedentariness and related functional decline that undermines current standards of HF care.

Existing models of exercise training for HF rely primarily on site-based regimens of aerobic and strength training modalities. Implementation barriers include unfeasible logistics for patients who often do not drive, particularly as many older patients struggle with frailty as well as limitations due to cognitive decline, sensory impairment, and/or socioeconomic challenges amidst the predictable complexities associated with advanced age. Fear and poor motivation compound these limitations, with limited options to motivate, supervise, and track progress for many candidates.

This proposal promotes the concept of "Palliative Care Rehab" which is transformational in concept. It shifts the premise of cardiac rehabilitation from cardiorespiratory fitness to more rudimentary goals of activities of daily living and self-efficacy. Likewise, rather than focusing on traditional cardiovascular endpoints of exercise testing and high performance, this study is oriented to submaximal endpoints, fatigability, and qualitative metrics.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Investigator, Outcomes assessor

入排标准

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

入选标准

  • Patients with Advanced Heart Failure (HFrEF or HFpEF), with NYHA class II, III, or IV despite a minimum of
  • 6 weeks of treatment
  • Age >70 years
  • Male and Female
  • Optimal therapy according to AHA/ACC and HFSA HF guidelines

排除标准

  • Patients living in an institutional setting (e.g., skilled nursing home) during the intended period of this study.
  • Major cardiovascular event or procedure within the prior 6 weeks.
  • HF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction). If valve replacement has been performed, the participant may not be enrolled for 12 months after this procedure.
  • Severe COPD (FEV1<50%), PVD, and/or Anemia
  • End-stage malignancy
  • Severe valvular heart disease
  • Psychiatric hospitalization within the last 3 months
  • Chronic ETOH or drug dependency.
  • We will exclude all of the following special populations:
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

研究组 & 干预措施

Standard of Care

Active Comparator

Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.

干预措施: Standard of Care (Other)

IMT Group: Inspiratory Muscle Training (IMT)

Experimental

IMT exercise sessions addition to standard of care.

干预措施: Inspiratory Muscle Training (IMT) (Other)

结局指标

主要结局

Safety of a 12-week home-based IMT program.

时间窗: Baseline and weekly for 12 weeks

AE/SAE (IMT vs. controls): number Completion of the 3-month intervention (IMT vs. controls)

Completion of 3-month Assessment

时间窗: 3-month

The number of participants who complete the 3-month assessment is used as a measure of intervention feasibility. Completion of this assessment indicates the feasibility of retaining participants in the study throughout the 3-month intervention period.

次要结局

  • Adherence to IMT training sessions(Baseline and weekly for 12 weeks)
  • Improvement in MIP(Baseline, 12 weeks)
  • Gait speed(Baseline, 12 weeks)
  • Grip strength(Baseline, 12 weeks)
  • Self-efficacy(Baseline, 12 weeks)
  • Sit to stand(Baseline, 12 weeks)
  • Quality of Life(Baseline, 12 weeks)
  • Fatigue(Baseline, 12 weeks)
  • Change in MIP (Maximum Inspiratory Pressure)(Baseline to 3-months)
  • Change in Sit to Stand Time(Baseline to 3-months)
  • Change in Gait Speed(Baseline to 3-month)
  • Change in the Sullivan Self-Efficacy to Maintain Function Scale(Baseline to 3-month)
  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ): Quality of Life Score(Baseline to 3-month)
  • Change in Fatigue(Baseline to 3-month)
  • Change in Grip Strength: kg(Baseline to 3-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Forman, MD

Professor

University of Pittsburgh

研究点 (2)

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