An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Rate Response; Orthostasis
• Intervention / Treatment: Diagnostic test: Active Stand

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: Caitríona Quinn, BSc; Phone Number: (01) 8963613; Email: quinnc18@tcd.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • Clinical Research Facility, St James's Hospital
    • Contact: Caitríona Quinn; Phone Number: (01) 8963613; Email: quinnc18@tcd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Heart Rate	R-R interval is recorded by portable ECG throughout assessment	60 seconds prior to standing assessment
Maximum heart rate	R-R interval is recorded by portable ECG throughout assessment	Within 3 minutes of standing assessment
Minimum heart rate	R-R interval is recorded by portable ECG throughout assessment	Within 3 minutes of standing assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	gender, age, relevant past medical history	Day 1
Height	Centimeters	Day 1
Weight	Kilograms	Day 1
Body Mass Index	Kg/m^2	Day 1
Body Fat Percentage	Percentage	Day 1
Blood Pressure	Blood Pressure	At baseline
Vascular Stiffness	Pulse Wave Analysis conducted using the Mobil-O-Graph 24-hour Pulse Wave Analysis (PWA) system.	Day 1

Collaborators and Investigators

• Sponsor: Caitríona Quinn
• Investigators: Principal Investigator: John Gormley, PhD, University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Active Stand; Heart rate response
• Additional Relevant MeSH Terms: Neurologic Manifestations; Sensation Disorders; Dizziness
• Other Study ID Numbers: AS repeatability

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will not be shared with outside parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No