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临床试验/NCT06030115
NCT06030115已完成不适用

Effects of a Physical Therapist-driven Individualized Hybrid Model of the Exercise Component of Cardiac Rehabilitation on Patient Outcomes: a Prospective Cohort Study

Good Shepherd Integrated Healthcare Systems1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Six Minute Walk Test

研究概览

简要总结

Determine if the standard of care at a cardiac rehabilitation center using what the investigators term to be "hybrid model" on the exercise component of cardiac rehabilitation is associated with improved adherence and outcomes. Discuss the hybrid model in comparison to traditional cardiac rehabilitation and layout a template on how to incorporate this hybrid model. Discuss factors that may lead to poor adherence and attendance to cardiac rehabilitation.

详细描述

Purpose: The aim of this prospective cohort study was to determine the effectiveness of an individualized physical therapist (PT) driven hybrid model of the exercise component of cardiac rehabilitation (CR) that uses a novel intensity-recovery progression protocol (IRPP) and cardiac testing template (CTT) to assess achieved heart rate intensity (AHRI%), heart rate recovery (HRR%), and intensity-recovery total (IR%) as indicators to guide treatment.

Methods: Assessment of a subjective questionnaire, vital signs, treadmill 6-minute walk (6MW), 1-minute sit-to-stand (1STS), 1-minute step (1ST), and 1-minute agility square tests (1AST) were assessed on 100 participants during the 36-visit program. The hybrid model was led by a PT, was longer in duration, added high intensity interval training (HIIT) to continuous aerobic exercise training (CAET) and resistance training, and used a 1:1 treatment ratio. Treatment intensity and progression were measured based on clinical decision making through the IRPP and CTT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Underwent cardiac surgery (CABG, PCI with stent placement, and valve replacement)
  • Surgery was within the previous 365 days
  • Could independently ambulate into the facility.

排除标准

  • Implantable cardioverter defibrillator (ICD)
  • Pacemaker (PPM)
  • Heart Transplant
  • Left ventricular assist device (LVAD)
  • All other cardiac procedures not listed within inclusion criteria
  • Diagnosed a-fib
  • Participants who attended cardiac rehabilitation before

结局指标

主要结局

Six Minute Walk Test

时间窗: Six Minutes

Treadmill Six Minute Walk Test

Heart Rate Recovery (HRR%)

时间窗: One minute

Heart rate observed one minute after outcome measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first).

Timed Sit To Stand Test

时间窗: One Minute

A standardized test measuring how many times an individual can stand from a standardized seated position in one minute using hand support to push off.

Achieved Target Heart Rate (AHRI%)

时间窗: One minute

Heart rate achieved during outcome measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first). Participants expected to attend the program at a frequency of 2x a week for 36 total visits.

Timed Step Test

时间窗: One Minute

A test measuring how many repetitions an individual can go up and down a standardized step while using bilateral arm support on a rail.

Timed Agility Square Test

时间窗: One Minute

Using agility ladder square to go in and out of designated two boxes

Intensity Recovery Total Score (IR%)

时间窗: One minute

The total of the AHRI + HRR during objective measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first).

Subjective Questionnaire

时间窗: From date of initiation of study up to 1 year after initiation. Collected on Visit 1, Visit 15, Visit 30 for each participant, who were expected to attend the program at a frequency of 2x a week for 36 total sessions.

Three questions (where higher scores denote better outcomes) Question 1: Rate your endurance (using a visual analog scale from 0-100% marked every 10%)? Question 2: Estimate how many stairs you could go up using arm support before you would have to take a break? Question 3: Estimate how many hours of exercise you completed in the previous 7 days?

次要结局

未报告次要终点

研究者

发起方
Good Shepherd Integrated Healthcare Systems
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Minchin

Physical Therapist, Rehabilitation Director

Good Shepherd Integrated Healthcare Systems

研究点 (1)

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