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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Valve Disease, Heart
• Interventions: Other: Educational session with Keep Your Move in the Tube and PrimusRS

• Registration Number: NCT05924568
• Lead Sponsor: Brandon Hathorn

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.

Study Timeline

• Study Start: 2015-05-13
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-21
• Last Update Submitted: 2023-06-28
• Study First Posted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Median Sternotomy	Educational session with Keep Your Move in the Tube and PrimusRS	-

Primary Outcome Measures

Name	Time	Method
Force pounds lifted post-median sternotomy	Day 1 or 2 of protocol	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

Name	Time	Method
Changes in confidence to perform ADLs	Day 1 or 2 of protocol	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)