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

NCT05924568 | Completed

• 1 other identifier: 015-050
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Valve Disease, Heart

Keywords

Coronary artery bypass graft; Valve replacement; Valve Repair; Median Sternotomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 or 2 of protocol

Secondary Outcomes (1)

• Changes in confidence to perform ADLs

  Day 1 or 2 of protocol

Study Arms (1)

Median Sternotomy

EXPERIMENTAL

Other: Educational session with Keep Your Move in the Tube and PrimusRS

Interventions

Educational session with Keep Your Move in the Tube and PrimusRS OTHER

Median Sternotomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CABG through median sternotomy
• Valve repair or replacement through median sternotomy
• Any ethic of socio-economic status

You may not qualify if:

• 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

Sponsors & Collaborators

• Brandon Hathorn: lead
• Baylor Heart and Vascular Institute Cardiovascular Research Review Committee: collaborator

Related Publications (15)

• 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.

  PMID: 24440333 BACKGROUND

• 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.

  PMID: 24982558 BACKGROUND

• 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.

  PMID: 24982569 BACKGROUND

• 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.

  PMID: 23543963 BACKGROUND

• 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.

  PMID: 23382610 BACKGROUND

• 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.

  PMID: 23144121 BACKGROUND

• 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.

  PMID: 20396420 BACKGROUND

• 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.

  PMID: 20157495 BACKGROUND

• 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.

  PMID: 19268728 BACKGROUND

• 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.

  PMID: 19169389 BACKGROUND

• 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.

  PMID: 19169393 BACKGROUND

• 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.

  PMID: 18360188 BACKGROUND

• 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.

  PMID: 18481235 BACKGROUND

• 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.

  PMID: 17252043 BACKGROUND

• 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.

  PMID: 16442380 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Brandon Hathorn, B.S.

  Baylor Scott and White Health Heart and Vascular Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Exercise Physiologist

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: May 13, 2015
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share