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临床试验/NCT04092166
NCT04092166已完成不适用

Impact of a Structured Cardiac Rehabilitation Program on Cardiorespiratory Fitness in Patients With Atrial Fibrillation

Valley Health System2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月1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
发起方
入组人数
20
试验地点
2
主要终点
Will a cardiac rehab program increase cardiorespiratory fitness in Afib patients?

研究概览

简要总结

The objective of this study is to determine whether participation in an 8-week structured cardiac rehabilitation program can increase cardiorespiratory fitness in patients with atrial fibrillation.

详细描述

The study is a randomized, prospective single center study to assess the utility and efficacy of cardiac rehabilitation in patients with AF. All participants will receive the same medical care and standard baseline education which includes an hour long one on one session with a nutritionist.

Participants will also receive the guide book, Lifestyle Guide to Healing the Heart, at their baseline visit as part of their education

After obtaining informed consent to participate in the study and signing a consent form to participate in the Phase 3 cardiac rehabilitation program, participants will undergo a baseline assessment of their functional status using the functional capacity NuStep test. The NuStep test will be conducted at the Valley Hospital at baseline and after 8 weeks using the NuStep TRS 4000 machine - a stationary bike machine that also engages one's arms by pushing and pulling arm handles. Participants will sit in the NuStep machine and bike on level 4 (a low to moderate level) for 6 minutes, if possible. However, participants will be encouraged to step as quickly as possible during this time period. Participants will be asked about any discomfort before, during and after the test. The participant's METS are calculated directly by the machine based on the watts while exercising.

The degree of improvement of the participant's METS over the course of the 8-week program will produce a greater understanding of the effect of a structured cardiac rehabilitation program on cardiorespiratory fitness.

Following this baseline assessment, participants will then be randomized to undergo usual care or an 8-week (24-session) Phase 3 cardiac rehabilitation program at the Valley Health System Center for Health & Wellness in Mahwah. Eight weeks later, participants will undergo repeat assessment of functional status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Age ≥ 18 years
  • Individuals with paroxysmal or persistent AF
  • Individuals with a BMI between 27 and 40

排除标准

  • Inability to engage with a cardiac rehabilitation program
  • Pregnant women
  • If patient can perform exercise at a high intensity (6 METS or above), they will no longer be analyzed in the study

研究组 & 干预措施

Controlled

No Intervention

Participants will have no intervention.

Cardiac Rehab Exercise: Stationary Bike

Other

Participants will use a stationary bike machine that also engages the arms and use . This will be performed for 6 minutes, 3 times a week for a total of 8 weeks).

干预措施: Stationary Bike (Other)

结局指标

主要结局

Will a cardiac rehab program increase cardiorespiratory fitness in Afib patients?

时间窗: 1 year

The primary endpoint of the study is to determine whether engagement with an 8-week, 24- session cardiac rehabilitation program can increase exercise capacity by 2 METS, a threshold that has previously been shown to improve patient outcomes.

次要结局

未报告次要终点

研究者

发起方
Valley Health System
申办方类型
Other
责任方
Sponsor

研究点 (2)

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