NCT Number: NCT05924568
Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting
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.
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
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)
Sponsors and collaborators
Lead sponsor
Brandon Hathorn
Other
Collaborators
- Baylor Heart and Vascular Institute Cardiovascular Research Review Committee
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Jun 29, 2023
- Registry last updated
- Jul 3, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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