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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05924568
Enrollment
Unknown
Registered
2023-06-29
Start date
2015-05-13
Completion date
2022-11-01
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Valve Disease, Heart

Keywords

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

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.

Interventions

OTHEREducational session with Keep Your Move in the Tube and PrimusRS

Sponsors

Baylor Heart and Vascular Institute Cardiovascular Research Review Committee
CollaboratorUNKNOWN
Brandon Hathorn
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Force pounds lifted post-median sternotomyDay 1 or 2 of protocolDetermining if performed force measurements yield a different recommended weight lifted during the sternotomy healing process than the traditional gold standard of 5 pounds.

Secondary

MeasureTime frameDescription
Changes in confidence to perform ADLsDay 1 or 2 of protocolChange 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026