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
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
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
NCT ID
NCT05924568
First Posted
June 21, 2023
Last Updated
June 28, 2023
Sponsor
Brandon Hathorn
Collaborators
Baylor Heart and Vascular Institute Cardiovascular Research Review Committee
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
background
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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