Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06030115
• Other study ID #: GoodShepherdIHS
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2023
• Source: Good Shepherd Integrated Healthcare Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiac Surgery
• Stent
• Valve Replacement

Intervention

Other:
• Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)
Data collected on participants who completed the intensity recovery progression protocol program

Locations

Country	Name	City	State
United States	Good Shepherd Integrated Healthcare Systems	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Good Shepherd Integrated Healthcare Systems

Country where clinical trial is conducted

United States, 

References & Publications (70)

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* Note: There are 70 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six Minute Walk Test	Treadmill Six Minute Walk Test	Six Minutes
Primary	Timed Sit To Stand Test	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.	One Minute
Primary	Timed Step Test	A test measuring how many repetitions an individual can go up and down a standardized step while using bilateral arm support on a rail.	One Minute
Primary	Timed Agility Square Test	Using agility ladder square to go in and out of designated two boxes	One Minute
Primary	Achieved Target Heart Rate (AHRI%)	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.	One minute
Primary	Heart Rate Recovery (HRR%)	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).	One minute
Primary	Intensity Recovery Total Score (IR%)	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).	One minute
Primary	Subjective Questionnaire	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?	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.