Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924568
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2023-06-21
Brief Title:
Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting
Sponsor:
Brandon Hathorn
Organization:
Baylor Research Institute
Study Overview
Official Title:
Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects 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 240110 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 andor placing an object overhead Following the performance of the activities the patients will be asked to complete a post-activity confidence survey
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None