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Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting

Primary Purpose

Coronary Artery Disease, Valve Disease, Heart

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational session with Keep Your Move in the Tube and PrimusRS
Sponsored by
Brandon Hathorn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery bypass graft, Valve replacement, Valve Repair, Median Sternotomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: CABG through median sternotomy Valve repair or replacement through median sternotomy Any ethic of socio-economic status Exclusion Criteria: Refusal to participate Sternal dehiscence Permanent pacemaker Permanent defibrillator Unstable angina History of heart transplant History of hernia History of aneurysm Physical disability that limits resistance training Uncontrolled hypertension (systolic 160 mmHg or diastolic > 100 mmHg) Symptomatic dysrhythmias History of aortic dissection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Median Sternotomy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Force pounds lifted post-median sternotomy
    Determining if performed force measurements yield a different recommended weight lifted during the sternotomy healing process than the traditional gold standard of 5 pounds.

    Secondary Outcome Measures

    Changes in confidence to perform ADLs
    Change in confidence for ADLs post-sternotomy with a questionnaire pre and post protocol (Scale: 1-5; with 1 being the least confident and 5 being the most confident)

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    June 28, 2023
    Sponsor
    Brandon Hathorn
    Collaborators
    Baylor Heart and Vascular Institute Cardiovascular Research Review Committee
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05924568
    Brief Title
    Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting
    Official Title
    Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 13, 2015 (Actual)
    Primary Completion Date
    November 1, 2022 (Actual)
    Study Completion Date
    November 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Brandon Hathorn
    Collaborators
    Baylor Heart and Vascular Institute Cardiovascular Research Review Committee

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if performed force measurements yield a different recommended weight lifted during the sternotomy healing process than the traditional gold standard of 5 pounds. A secondary endpoint data obtained will be scores from the pre and post-activity questionnaires.
    Detailed Description
    In a prospective study involving 130 cardiac rehabilitation patients muscular strength will be measured with a force dynamometer (PRIMUS) on six commonly performed activities. During the first session of cardiac rehabilitation, each subject's date of birth, height, and weight will be recorded. To ensure safety, cardiovascular nurse specialists and exercise physiologists will monitor the patients for hypertension (blood pressure >240/110 mm Hg), arrhythmias, angina, dizziness, pain, shortness of breath, and perceived exertion. The subjects will be asked to complete a pre-activity confidence survey. On the second day of cardiac rehabilitation, a clinical exercise specialist will the PRIMUS equipment to obtain force measurements on the six activities including: rising from a bed, rising from a chair, opening a door, lifting an object from the floor and/or placing an object overhead. Following the performance of the activities, the patients will be asked to complete a post-activity confidence survey.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Valve Disease, Heart
    Keywords
    Coronary artery bypass graft, Valve replacement, Valve Repair, Median Sternotomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Allocation
    N/A

    8. Arms, Groups, and Interventions

    Arm Title
    Median Sternotomy
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Educational session with Keep Your Move in the Tube and PrimusRS
    Primary Outcome Measure Information:
    Title
    Force pounds lifted post-median sternotomy
    Description
    Determining if performed force measurements yield a different recommended weight lifted during the sternotomy healing process than the traditional gold standard of 5 pounds.
    Time Frame
    Day 1 or 2 of protocol
    Secondary Outcome Measure Information:
    Title
    Changes in confidence to perform ADLs
    Description
    Change in confidence for ADLs post-sternotomy with a questionnaire pre and post protocol (Scale: 1-5; with 1 being the least confident and 5 being the most confident)
    Time Frame
    Day 1 or 2 of protocol

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Eligibility Criteria
    Inclusion Criteria: CABG through median sternotomy Valve repair or replacement through median sternotomy Any ethic of socio-economic status Exclusion Criteria: Refusal to participate Sternal dehiscence Permanent pacemaker Permanent defibrillator Unstable angina History of heart transplant History of hernia History of aneurysm Physical disability that limits resistance training Uncontrolled hypertension (systolic 160 mmHg or diastolic > 100 mmHg) Symptomatic dysrhythmias History of aortic dissection
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brandon Hathorn, B.S.
    Organizational Affiliation
    Baylor Scott and White Health Heart and Vascular Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24440333
    Citation
    Adams J, Schmid J, Parker RD, Coast JR, Cheng D, Killian AD, McCray S, Strauss D, McLeroy Dejong S, Berbarie R. Comparison of force exerted on the sternum during a sneeze versus during low-, moderate-, and high-intensity bench press resistance exercise with and without the valsalva maneuver in healthy volunteers. Am J Cardiol. 2014 Mar 15;113(6):1045-8. doi: 10.1016/j.amjcard.2013.11.064. Epub 2013 Dec 25.
    Results Reference
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    PubMed Identifier
    24982558
    Citation
    Adams J, Cheng D, Lee J, Shock T, Kennedy K, Pate S. Use of the bootstrap method to develop a physical fitness test for public safety officers who serve as both police officers and firefighters. Proc (Bayl Univ Med Cent). 2014 Jul;27(3):199-202. doi: 10.1080/08998280.2014.11929107.
    Results Reference
    background
    PubMed Identifier
    24982569
    Citation
    Adams J, DeJong S, Arnett JK, Kennedy K, Franklin JO, Berbarie RF. High-intensity cardiac rehabilitation training of a firefighter after placement of an implantable cardioverter-defibrillator. Proc (Bayl Univ Med Cent). 2014 Jul;27(3):226-8. doi: 10.1080/08998280.2014.11929118.
    Results Reference
    background
    PubMed Identifier
    23543963
    Citation
    Adams J, Cheng D, Berbarie RF. High-intensity, occupation-specific training in a series of firefighters during phase II cardiac rehabilitation. Proc (Bayl Univ Med Cent). 2013 Apr;26(2):106-8. doi: 10.1080/08998280.2013.11928931.
    Results Reference
    background
    PubMed Identifier
    23382610
    Citation
    Adams J, Berbarie RF. High-intensity cardiac rehabilitation training of a police officer for his return to work and sports after coronary artery bypass grafting. Proc (Bayl Univ Med Cent). 2013 Jan;26(1):39-41. doi: 10.1080/08998280.2013.11928911.
    Results Reference
    background
    PubMed Identifier
    23144121
    Citation
    Adams J, Jordan S, Spencer K, Belanger J, Cheng D, Shock T, Karcher J. Energy expenditure in US automotive technicians and occupation-specific cardiac rehabilitation. Occup Med (Lond). 2013 Mar;63(2):103-8. doi: 10.1093/occmed/kqs192. Epub 2012 Nov 8.
    Results Reference
    background
    PubMed Identifier
    20396420
    Citation
    Adams J, Hubbard M, McCullough-Shock T, Simms K, Cheng D, Hartman J, Strauss D, Anderson V, Lawrence A, Malorzo E. Myocardial work during endurance training and resistance training: a daily comparison, from workout session 1 through completion of cardiac rehabilitation. Proc (Bayl Univ Med Cent). 2010 Apr;23(2):126-9. doi: 10.1080/08998280.2010.11928599.
    Results Reference
    background
    PubMed Identifier
    20157495
    Citation
    Adams J, Schneider J, Hubbard M, McCullough-Shock T, Cheng D, Simms K, Hartman J, Hinton P, Strauss D. Measurement of functional capacity requirements of police officers to aid in development of an occupation-specific cardiac rehabilitation training program. Proc (Bayl Univ Med Cent). 2010 Jan;23(1):7-10. doi: 10.1080/08998280.2010.11928571.
    Results Reference
    background
    PubMed Identifier
    19268728
    Citation
    Adams J, Roberts J, Simms K, Cheng D, Hartman J, Bartlett C. Measurement of functional capacity requirements to aid in development of an occupation-specific rehabilitation training program to help firefighters with cardiac disease safely return to work. Am J Cardiol. 2009 Mar 15;103(6):762-5. doi: 10.1016/j.amjcard.2008.11.032. Epub 2009 Jan 24.
    Results Reference
    background
    PubMed Identifier
    19169389
    Citation
    Naffe A, Iype M, Easo M, McLeroy SD, Pinaga K, Vish N, Wheelan K, Franklin J, Adams J. Appropriateness of sling immobilization to prevent lead displacement after pacemaker/implantable cardioverter-defibrillator implantation. Proc (Bayl Univ Med Cent). 2009 Jan;22(1):3-6. doi: 10.1080/08998280.2009.11928456.
    Results Reference
    background
    PubMed Identifier
    19169393
    Citation
    Schmid J, Adams J, Cheng D. Cardiac rehabilitation of a 77-year-old male runner: consideration of the athlete, not the age. Proc (Bayl Univ Med Cent). 2009 Jan;22(1):16-8. doi: 10.1080/08998280.2009.11928460.
    Results Reference
    background
    PubMed Identifier
    18360188
    Citation
    Adams J, Pullum G, Stafford P, Hanners N, Hartman J, Strauss D, Hubbard M, Lawrence A, Anderson V, McCullough T. Challenging traditional activity limits after coronary artery bypass graft surgery: a simulated lawn-mowing activity. J Cardiopulm Rehabil Prev. 2008 Mar-Apr;28(2):118-21. doi: 10.1097/01.HCR.0000314206.94428.9f.
    Results Reference
    background
    PubMed Identifier
    18481235
    Citation
    Parker R, Adams JL, Ogola G, McBrayer D, Hubbard JM, McCullough TL, Hartman JM, Cleveland T. Current activity guidelines for CABG patients are too restrictive: comparison of the forces exerted on the median sternotomy during a cough vs. lifting activities combined with valsalva maneuver. Thorac Cardiovasc Surg. 2008 Jun;56(4):190-4. doi: 10.1055/s-2008-1038470.
    Results Reference
    background
    PubMed Identifier
    17252043
    Citation
    Adams J, Cline M, Reed M, Masters A, Ehlke K, Hartman J. Importance of resistance training for patients after a cardiac event. Proc (Bayl Univ Med Cent). 2006 Jul;19(3):246-8. doi: 10.1080/08998280.2006.11928172. No abstract available.
    Results Reference
    background
    PubMed Identifier
    16442380
    Citation
    Adams J, Cline MJ, Hubbard M, McCullough T, Hartman J. A new paradigm for post-cardiac event resistance exercise guidelines. Am J Cardiol. 2006 Jan 15;97(2):281-6. doi: 10.1016/j.amjcard.2005.08.035. Epub 2005 Nov 21.
    Results Reference
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    Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting

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