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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 : Not yet recruiting
First Posted : June 10, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Caitríona Quinn, St. James's Hospital, Ireland

Brief Summary:

Study background:

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.

Research aims:

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.

Study design:

This will be a repeatability study with between group comparison.

Study setting:

This study will take place in the Clinical Research Facility in St James's Hospital.

Participants:

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

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Baseline Heart Rate [ Time Frame: 60 seconds prior to standing assessment ]
    R-R interval is recorded by portable ECG throughout assessment

  2. Maximum heart rate [ Time Frame: Within 3 minutes of standing assessment ]
    R-R interval is recorded by portable ECG throughout assessment

  3. Minimum heart rate [ Time Frame: Within 3 minutes of standing assessment ]
    R-R interval is recorded by portable ECG throughout assessment


Secondary Outcome Measures :
  1. Demographic data [ Time Frame: Day 1 ]
    gender, age, relevant past medical history

  2. Height [ Time Frame: Day 1 ]
    Centimeters

  3. Weight [ Time Frame: Day 1 ]
    Kilograms

  4. Body Mass Index [ Time Frame: Day 1 ]
    Kg/m^2

  5. Body Fat Percentage [ Time Frame: Day 1 ]
    Percentage

  6. Blood Pressure [ Time Frame: At baseline ]
    Blood Pressure

  7. Vascular Stiffness [ Time Frame: Day 1 ]
    Pulse Wave Analysis conducted using the Mobil-O-Graph 24-hour Pulse Wave Analysis (PWA) system.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults aged 18+ from the staff and students of Trinity College Dublin and St James's Hospital, from the Trinity Retirement Association and from the community in the SJH catchment area.
Criteria

Inclusion Criteria:

  • Healthy adults aged ≥18 (considering 18 is the age of legal consent).
  • Fluent in English.
  • Free of intellectual disability or cognitive impairment that would impair or impede the ability to give informed, explicit consent.
  • Free of all exclusion criteria below.

Exclusion Criteria:

  • Unstable or un-managed cardiac/respiratory/metabolic conditions (i.e. condition must be diagnosed and being managed as per medical input to be classified as stable and managed).
  • Neuro- musculoskeletal disorders.
  • Acute musculoskeletal injury or impairment (including acute pain).
  • Malignancy.
  • Mental illness.
  • Chronic infectious disease (Hep C/ HIV/ AIDS).
  • Acute systemic infection or illness.
  • Taking medication that affects cardiovascular function.
  • Exclusion for any other reason deemed appropriate by the research team.

Information from the National Library of Medicine

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


Contacts
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Contact: Caitríona Quinn, BSc (01) 8963613 quinnc18@tcd.ie

Sponsors and Collaborators
Caitríona Quinn
Investigators
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Principal Investigator: John Gormley, PhD University of Dublin, Trinity College
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Responsible Party: Caitríona Quinn, Research Physiotherapist, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT04921059    
Other Study ID Numbers: AS repeatability
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be shared with outside parties.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caitríona Quinn, St. James's Hospital, Ireland:
Heart rate response
Active Stand
Additional relevant MeSH terms:
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Dizziness
Sensation Disorders
Neurologic Manifestations