Cardiac SurgeryNCT06030115

Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes

An observational study of Cardiac Surgery and Coronary Artery Bypass Graft CABG, run by Good Shepherd Integrated Healthcare Systems at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Cardiac Surgery, Coronary Artery Bypass Graft CABG, Stent
What is being tested?: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2019to 31 Jul 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Good Shepherd Integrated Healthcare Systems
Las Vegas, Nevada, 89119

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Cardiac Surgery, Coronary Artery Bypass Graft CABG, Stent, Valve Replacement
Being tested: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)
Keywords: Physical Therapy, Cardiopulmonary Rehabilitation, Cardiac Surgery, Exercise, Heart Rate, Objective Outcome Assessments
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06030115
Study group	Role	What they receive
Cardiac Rehab Patients		All participants referred to the clinic meeting the inclusion and exclusion criteria who wanted to participate in the study. Receives: Other: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Six Minute Walk Test
Treadmill Six Minute Walk Test
Measured: 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.
Measured: 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.
Measured: One Minute
Timed Agility Square Test
Using agility ladder square to go in and out of designated two boxes
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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?
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201931 Jul 2021

First posted8 Sep 2023
Study start1 Jul 2019
Primary completion31 Jul 2021
Study completion31 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (70)Papers the sponsor has linked to this study.
Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06030115
Sponsor's protocol ID: GoodShepherdIHS
Status last verified: Sep 2023
First submitted: 24 Aug 2023
Last updated: 8 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD (decodified) will be stored in a password protected laptop in a locked room in a locked file cabinet at the clinic site. The statistical summarized analysis will be the main focus for the public and other researchers. The cardiac testing template in excel format will be available for other researchers looking to use the hybrid model explained in the study, however, this template will not contain individualized personal data.

Publications

National Vital Statistics System. Mortality Mulitple Cause-of-Death: Centers for Disease Control adn Prevention; 2021 [Available from:
Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PubMed 35078371
Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.
PubMed 22070836
Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; ACCF; AHA; SCAI. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):453-95. doi: 10.1002/ccd.23438. No abstract available.
PubMed 22328235
Wenger NK. Current status of cardiac rehabilitation. J Am Coll Cardiol. 2008 Apr 29;51(17):1619-31. doi: 10.1016/j.jacc.2008.01.030.
PubMed 18436113
Winzer EB, Woitek F, Linke A. Physical Activity in the Prevention and Treatment of Coronary Artery Disease. J Am Heart Assoc. 2018 Feb 8;7(4):e007725. doi: 10.1161/JAHA.117.007725. No abstract available.
PubMed 29437600
Origuchi H, Itoh H, Momomura SI, Nohara R, Daida H, Masuda T, Kohzuki M, Makita S, Ueshima K, Nagayama M, Omiya K, Adachi H, Goto Y. Active Participation in Outpatient Cardiac Rehabilitation Is Associated With Better Prognosis After Coronary Artery Bypass Graft Surgery - J-REHAB CABG Study. Circ J. 2020 Feb 25;84(3):427-435. doi: 10.1253/circj.CJ-19-0650. Epub 2020 Feb 8.
PubMed 32037378
Mampuya WM. Cardiac rehabilitation past, present and future: an overview. Cardiovasc Diagn Ther. 2012 Mar;2(1):38-49. doi: 10.3978/j.issn.2223-3652.2012.01.02.
PubMed 24282695
Keteyian SJ, Jackson SL, Chang A, Brawner CA, Wall HK, Forman DE, Sukul D, Ritchey MD, Sperling LS. Tracking Cardiac Rehabilitation Utilization in Medicare Beneficiaries: 2017 UPDATE. J Cardiopulm Rehabil Prev. 2022 Jul 1;42(4):235-245. doi: 10.1097/HCR.0000000000000675. Epub 2022 Feb 8.
PubMed 35135961
Ritchey MD, Maresh S, McNeely J, Shaffer T, Jackson SL, Keteyian SJ, Brawner CA, Whooley MA, Chang T, Stolp H, Schieb L, Wright J. Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a National Initiative. Circ Cardiovasc Qual Outcomes. 2020 Jan;13(1):e005902. doi: 10.1161/CIRCOUTCOMES.119.005902. Epub 2020 Jan 14.
PubMed 31931615
Thomas RJ, Balady G, Banka G, Beckie TM, Chiu J, Gokak S, Ho PM, Keteyian SJ, King M, Lui K, Pack Q, Sanderson BK, Wang TY. 2018 ACC/AHA Clinical Performance and Quality Measures for Cardiac Rehabilitation: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2018 Apr 24;71(16):1814-1837. doi: 10.1016/j.jacc.2018.01.004. Epub 2018 Mar 29. No abstract available.
PubMed 29606402
Beatty AL, Li S, Thomas L, Amsterdam EA, Alexander KP, Whooley MA. Trends in referral to cardiac rehabilitation after myocardial infarction: data from the National Cardiovascular Data Registry 2007 to 2012. J Am Coll Cardiol. 2014 Jun 17;63(23):2582-2583. doi: 10.1016/j.jacc.2014.03.030. Epub 2014 Apr 23. No abstract available.
PubMed 24768872
Peters AE, Keeley EC. Trends and Predictors of Participation in Cardiac Rehabilitation Following Acute Myocardial Infarction: Data From the Behavioral Risk Factor Surveillance System. J Am Heart Assoc. 2017 Dec 29;7(1):e007664. doi: 10.1161/JAHA.117.007664.
PubMed 29288154
Resurreccion DM, Motrico E, Rigabert A, Rubio-Valera M, Conejo-Ceron S, Pastor L, Moreno-Peral P. Barriers for Nonparticipation and Dropout of Women in Cardiac Rehabilitation Programs: A Systematic Review. J Womens Health (Larchmt). 2017 Aug;26(8):849-859. doi: 10.1089/jwh.2016.6249. Epub 2017 Apr 7.
PubMed 28388314
Lee M, Wood T, Chan S, Marziali E, Tang T, Banner D, Lear SA. Cardiac rehabilitation program: An exploration of patient experiences and perspectives on program dropout. Worldviews Evid Based Nurs. 2022 Feb;19(1):56-63. doi: 10.1111/wvn.12554. Epub 2022 Jan 17.
PubMed 35040245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06030115
Acronym / sponsor ID: GoodShepherdIHS
Conditions: Cardiac Surgery, Coronary Artery Bypass Graft CABG, Stent, Valve Replacement
Keywords: Physical Therapy, Cardiopulmonary Rehabilitation, Cardiac Surgery, Exercise, Heart Rate, Objective Outcome Assessments
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Good Shepherd Integrated Healthcare SystemsUniversity, hospital or other
Study start: 1 Jul 2019 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 31 Jul 2021 (actual)
First posted: 8 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cardiac Rehab Patients	–	Other: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)All participants referred to the clinic meeting the inclusion and exclusion criteria who wanted to participate in the study.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

Implantable cardioverter defibrillator (ICD)
Pacemaker (PPM)
Heart Transplant
Left ventricular assist device (LVAD)
All other cardiac procedures not listed within inclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)Data collected on participants who completed the intensity recovery progression protocol program	Other	Cardiac Rehab Patients

Primary outcome

Six Minute Walk Test
Time frame: Six Minutes
Treadmill Six Minute Walk Test
Timed Sit To Stand Test
Time frame: 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.
Timed Step Test
Time frame: 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
Time frame: One Minute
Using agility ladder square to go in and out of designated two boxes
Achieved Target Heart Rate (AHRI%)
Time frame: 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.
Heart Rate Recovery (HRR%)
Time frame: 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).
Intensity Recovery Total Score (IR%)
Time frame: 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
Time frame: 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?

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
BackgroundNational Vital Statistics System. Mortality Mulitple Cause-of-Death: Centers for Disease Control adn Prevention; 2021 [Available from:
Background: PubMed 35078371Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
Background: PubMed 22070836Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.
Background: PubMed 22328235Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; ACCF; AHA; SCAI. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):453-95. doi: 10.1002/ccd.23438. No abstract available.
Background: PubMed 18436113Wenger NK. Current status of cardiac rehabilitation. J Am Coll Cardiol. 2008 Apr 29;51(17):1619-31. doi: 10.1016/j.jacc.2008.01.030.
Background: PubMed 29437600Winzer EB, Woitek F, Linke A. Physical Activity in the Prevention and Treatment of Coronary Artery Disease. J Am Heart Assoc. 2018 Feb 8;7(4):e007725. doi: 10.1161/JAHA.117.007725. No abstract available.
Background: PubMed 32037378Origuchi H, Itoh H, Momomura SI, Nohara R, Daida H, Masuda T, Kohzuki M, Makita S, Ueshima K, Nagayama M, Omiya K, Adachi H, Goto Y. Active Participation in Outpatient Cardiac Rehabilitation Is Associated With Better Prognosis After Coronary Artery Bypass Graft Surgery - J-REHAB CABG Study. Circ J. 2020 Feb 25;84(3):427-435. doi: 10.1253/circj.CJ-19-0650. Epub 2020 Feb 8.
Background: PubMed 24282695Mampuya WM. Cardiac rehabilitation past, present and future: an overview. Cardiovasc Diagn Ther. 2012 Mar;2(1):38-49. doi: 10.3978/j.issn.2223-3652.2012.01.02.
Background: PubMed 35135961Keteyian SJ, Jackson SL, Chang A, Brawner CA, Wall HK, Forman DE, Sukul D, Ritchey MD, Sperling LS. Tracking Cardiac Rehabilitation Utilization in Medicare Beneficiaries: 2017 UPDATE. J Cardiopulm Rehabil Prev. 2022 Jul 1;42(4):235-245. doi: 10.1097/HCR.0000000000000675. Epub 2022 Feb 8.
Background: PubMed 31931615Ritchey MD, Maresh S, McNeely J, Shaffer T, Jackson SL, Keteyian SJ, Brawner CA, Whooley MA, Chang T, Stolp H, Schieb L, Wright J. Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a National Initiative. Circ Cardiovasc Qual Outcomes. 2020 Jan;13(1):e005902. doi: 10.1161/CIRCOUTCOMES.119.005902. Epub 2020 Jan 14.
Background: PubMed 29606402Thomas RJ, Balady G, Banka G, Beckie TM, Chiu J, Gokak S, Ho PM, Keteyian SJ, King M, Lui K, Pack Q, Sanderson BK, Wang TY. 2018 ACC/AHA Clinical Performance and Quality Measures for Cardiac Rehabilitation: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2018 Apr 24;71(16):1814-1837. doi: 10.1016/j.jacc.2018.01.004. Epub 2018 Mar 29. No abstract available.
Background: PubMed 24768872Beatty AL, Li S, Thomas L, Amsterdam EA, Alexander KP, Whooley MA. Trends in referral to cardiac rehabilitation after myocardial infarction: data from the National Cardiovascular Data Registry 2007 to 2012. J Am Coll Cardiol. 2014 Jun 17;63(23):2582-2583. doi: 10.1016/j.jacc.2014.03.030. Epub 2014 Apr 23. No abstract available.
Individual participant dataSharing planned: No. IPD (decodified) will be stored in a password protected laptop in a locked room in a locked file cabinet at the clinic site. The statistical summarized analysis will be the main focus for the public and other researchers. The cardiac testing template in excel format will be available for other researchers looking to use the hybrid model explained in the study, however, this template will not contain individualized personal data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kevin Minchin, DPT principal investigator

Good Shepherd

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Surgery and Coronary Artery Bypass Graft CABG, run by Good Shepherd Integrated Healthcare Systems at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six Minute Walk Test (time frame: Six Minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06030115, which also lists 70 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.