An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04921059|
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : May 9, 2022
Impaired heart rate recovery following active stand is associated with morbidity and mortality. Evidence for the repeatability of this measure is limited. This study seeks to determine the repeatability of the active stand procedure in eliciting heart rate recovery in healthy adults of all ages.
The aims of this study are to determine the repeatability of heart rate recovery in response to the active stand procedure among different age groups.
This will be a repeatability study with between group comparison.
This study will take place in the Clinical Research Facility in St James's Hospital.
Participants will be recruited from the staff and student population of Trinity College Dublin and St James's Hospital, from the Trinity Retirement Association and from the community in the St. James's Hospital catchment area. Participants will be healthy adults (over 18 years old). They will be invited to participate via an email and poster campaign. Participation will be fully voluntary. Participants who meet inclusion criteria will be selected. Informed, explicit voluntary consent will be obtained from each participant.
Data collection and processing:
Data collection and processing will be carried out by the Research Physiotherapist. A clinical visit for the participant will be arranged at a time most convenient for them. Participants will conduct the active stand assessment on three occasions.
|Condition or disease||Intervention/treatment|
|Heart Rate Response Orthostasis||Diagnostic Test: Active Stand|
|Study Type :||Observational|
|Estimated Enrollment :||125 participants|
|Official Title:||An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols|
|Actual Study Start Date :||November 17, 2021|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||December 2022|
- Diagnostic Test: Active Stand
The participant is asked to lie down for 10 mins without moving or speaking. A heart rate monitor is attached while the participant is lying down. They are then asked to stand up as quickly as possible and to remain standing unassisted for 3 minutes. The participant will be asked to describe any symptoms at 1 and 3 minutes after standing. Blood pressure and heart rate will be monitored constantly throughout the test.
- Baseline Heart Rate [ Time Frame: 60 seconds prior to standing assessment ]R-R interval is recorded by portable ECG throughout assessment
- Maximum heart rate [ Time Frame: Within 3 minutes of standing assessment ]R-R interval is recorded by portable ECG throughout assessment
- Minimum heart rate [ Time Frame: Within 3 minutes of standing assessment ]R-R interval is recorded by portable ECG throughout assessment
- Demographic data [ Time Frame: Day 1 ]gender, age, relevant past medical history
- Height [ Time Frame: Day 1 ]Centimeters
- Weight [ Time Frame: Day 1 ]Kilograms
- Body Mass Index [ Time Frame: Day 1 ]Kg/m^2
- Body Fat Percentage [ Time Frame: Day 1 ]Percentage
- Blood Pressure [ Time Frame: At baseline ]Blood Pressure
- Vascular Stiffness [ Time Frame: Day 1 ]Pulse Wave Analysis conducted using the Mobil-O-Graph 24-hour Pulse Wave Analysis (PWA) system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921059
|Contact: Caitríona Quinn, BSc||(01) firstname.lastname@example.org|
|Clinical Research Facility, St James's Hospital||Recruiting|
|Contact: Caitríona Quinn (01) 8963613 email@example.com|
|Principal Investigator:||John Gormley, PhD||University of Dublin, Trinity College|