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临床试验/NCT06951620
NCT06951620招募中不适用

Optimizing Aerobic Fitness and Functional Response to Exercise in Older Adults

University of Vermont Medical Center1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年4月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
114
试验地点
1
主要终点
Change in Aerobic fitness

研究概览

简要总结

Hospitalization and treatment for cardiovascular disease is one of the main contributors to disability in older adults. Moderate intensity continuous aerobic and resistance training have been the cornerstone of cardiac rehabilitation (CR) for decades to remediate hospital-acquired functional deficits, but some groups receive less or minimal functional benefit from this training. The proposed studies seek to optimize recovery of aerobic fitness and physical function among older cardiac patients using a novel high intensity training regimen with the long-term goal of reducing subsequent disability and improving clinical outcomes.

详细描述

Clinical events and hospitalization often initiate disability in older adults with cardiovascular disease (CVD) being the primary cause of hospital acquired disability. Cardiac rehabilitation (CR) was designed to correct this disability, with moderate intensity, continuous aerobic training (MICT) as its foundation but some patients, including older adults, receive less functional benefit from MICT. Attention has recently focused on high intensity interval aerobic training (HIIT) as an alternative to MICT because it improves aerobic fitness to a greater extent and is safe and feasible for older adults enrolled in CR; however, neither HIIT nor MICT address age-related atrophy and weakness. Resistance training is a core component of CR meant to correct these deficits, but the moderate intensity resistance training (MIRT) most commonly used has minimal effects on these outcomes. Thus, there is an unmet clinical need for multi-modal exercise interventions that address the unique needs of older adult patients enrolled in CR to optimize improvements in functional recovery and clinical outcomes.

The investigators will conduct the first direct comparison of HIIT+HIRT to MICT+MIRT to improve VO2peak and physical function in older men and women enrolled in CR.

Aim 1: Determine the efficacy of combined HIIT+HIRT vs MICT+MIRT to increase VO2peak in older adult patients enrolled in CR Aim 2: Determine the efficacy of combined HIIT+HIRT vs MICT+MIRT to increase physical function in older adult patients enrolled in CR.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •>65 years old
  • •ambulatory
  • •enrolled in CR at our center following a recent clinical diagnosis of myocardial infarction or percutaneous intervention will be recruited

排除标准

  • •have an active malignancy (excluding non-melanoma skin cancer or low grade prostate cancer under surveillance)
  • •unwilling to comply with the exercise prescription they may be assigned to
  • •have a submaximal performance on entry exercise tolerance test, defined as respiratory exchange ratio <1.0

研究组 & 干预措施

Intervention Group

Experimental

Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to High intensity training

干预措施: HIIT (Other)

Usual Care Group

Experimental

Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to Moderate intensity training

干预措施: MICT (Other)

结局指标

主要结局

Change in Aerobic fitness

时间窗: Within 4 months of the intake assessment

Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).

Change in 30 sec sit-to-stand test (STS)

时间窗: Within 4 months of the intake assessment

Changes in STS will be measured from intake to completion of the intervention (4 months after intake).

次要结局

  • Changes in Quality of Life- Cardiac Specific(Within 4 months of the intake assessment)
  • Changes in Depressive Symptoms(Within 4 months of the intake assessment)
  • Changes in Executive Function (digit span)(Within 4 months of the intake assessment)
  • Changes in Executive Function (BRIEF)(Within 4 months of the intake assessment)
  • Changes in Executive Function (trail making)(Within 4 months of the intake assessment)
  • Changes in Physical Function (Six Minute Walk Test)(Within 4 months of the intake assessment)
  • Changes in Enjoyment of Exercise (PACES)(Within 4 months of the intake assessment)
  • Changes in Anxiety(Within 4 months of the intake assessment)

研究者

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

Sherrie Khadanga

Principal Investigator

University of Vermont Medical Center

研究点 (1)

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