Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes

NCT06030115 | Completed

• 1 other identifier: GoodShepherdIHS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery; Coronary Artery Bypass Graft CABG; Stent; Valve Replacement

Keywords

Physical Therapy; Cardiopulmonary Rehabilitation; Cardiac Surgery; Exercise; Heart Rate; Objective Outcome Assessments

Outcome Measures

Primary Outcomes (8)

• Six Minute Walk Test

  Treadmill Six Minute Walk Test

  Six Minutes

• 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

• 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

• Timed Agility Square Test

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

  One Minute

• 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

• 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

• 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

• 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.

Study Arms (1)

Cardiac Rehab Patients

All participants referred to the clinic meeting the inclusion and exclusion criteria who wanted to participate in the study.

Other: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)

Interventions

Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP) OTHER

Data collected on participants who completed the intensity recovery progression protocol program

Cardiac Rehab Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants analyzed (73 males, 27 females) had an average starting age of 66.1 years (SD=9.6; range 41-88 years). The admitting diagnoses were 50% stent, 37% CABG, 8% valve replacement and 5% a combination of the above.

You may qualify if:

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

You may not qualify if:

• Implantable cardioverter defibrillator (ICD)
• Pacemaker (PPM)
• Heart Transplant
• Left ventricular assist device (LVAD)
• Diagnosed a-fib
• Participants who attended cardiac rehabilitation before

Sponsors & Collaborators

• Good Shepherd Integrated Healthcare Systems: lead

Study Sites (1)

Good Shepherd Integrated Healthcare Systems

Las Vegas, Nevada, 89119, United States

Location

Related Publications (70)

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• Bennett H, Parfitt G, Davison K, Eston R. Validity of Submaximal Step Tests to Estimate Maximal Oxygen Uptake in Healthy Adults. Sports Med. 2016 May;46(5):737-50. doi: 10.1007/s40279-015-0445-1.

  PMID: 26670455 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kevin Minchin, DPT

  Good Shepherd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, Rehabilitation Director

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 8, 2023
• Study Start: July 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)