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

June 28, 2023 updated by: Brandon Hathorn
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Median Sternotomy
Other: Educational session with Keep Your Move in the Tube and PrimusRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force pounds lifted post-median sternotomy
Time Frame: 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.
Day 1 or 2 of protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in confidence to perform ADLs
Time Frame: 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)
Day 1 or 2 of protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brandon Hathorn

Collaborators

Baylor Heart and Vascular Institute Cardiovascular Research Review Committee

Investigators

  • Principal Investigator: Brandon Hathorn, B.S., Baylor Scott and White Health Heart and Vascular Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2015

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 015-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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