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Coronary Artery DiseaseNCT05924568

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

A study testing Educational session with Keep Your Move in the Tube and PrimusRS in people with Coronary Artery Disease and Valve Disease, Heart, run by Brandon Hathorn.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease, Valve Disease, Heart
What is being tested?
Educational session with Keep Your Move in the Tube and PrimusRS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
Not given
Where
No sites listed yet
Study dates
13 May 2015to 1 Nov 2022
Phase
Interventional
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 18 to 80 years
  • All sexes
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Refusal to participate
  • Sternal dehiscence
  • Permanent pacemaker
  • Permanent defibrillator
  • Unstable angina
  • History of heart transplant
Show all 12Show fewer
  • 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

About this study

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.

Read the 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.

Being tested
Educational session with Keep Your Move in the Tube and PrimusRS
Keywords
Coronary artery bypass graft, Valve replacement, Valve Repair, Median Sternotomy
Medical subject headings
Coronary Artery Disease, Heart Valve Diseases

What participants receive

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

  • Educational session with Keep Your Move in the Tube and PrimusRSOther

Study groups in NCT05924568
Study groupRoleWhat they receive
Median SternotomyExperimentalNot described
Receives: Other: Educational session with Keep Your Move in the Tube and PrimusRS

What is being measured

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

  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.

    Measured: Day 1 or 2 of protocol

Secondary outcomes (1)

  1. 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)

    Measured: Day 1 or 2 of protocol

Timeline

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

  1. First posted29 Jun 2023
  2. Study start13 May 2015
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
IDs, dates and publications
ClinicalTrials.gov ID
NCT05924568
Sponsor's protocol ID
015-050
Status last verified
Jun 2023
First submitted
21 Jun 2023
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24440333

  • 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.

    PubMed 24982558

  • 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.

    PubMed 24982569

  • 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.

    PubMed 23543963

  • 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.

    PubMed 23382610

  • 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.

    PubMed 23144121

  • 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.

    PubMed 20396420

  • 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.

    PubMed 20157495

  • 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.

    PubMed 19268728

  • 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.

    PubMed 19169389

  • 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.

    PubMed 19169393

  • 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.

    PubMed 18360188

  • 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.

    PubMed 18481235

  • 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.

    PubMed 17252043

  • 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.

    PubMed 16442380

Questions about this trial

What is this clinical trial studying?

A study testing Educational session with Keep Your Move in the Tube and PrimusRS in people with Coronary Artery Disease and Valve Disease, Heart, run by Brandon Hathorn.

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 12 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Force pounds lifted post-median sternotomy (time frame: Day 1 or 2 of protocol). 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 NCT05924568, which also lists 15 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 3 Jul 2023.

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