Heart Rate ResponseNCT04921059
An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols
An observational study of Heart Rate Response and Orthostasis, run by Caitríona Quinn at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Response, Orthostasis
- What is being tested?
- Active Stand
- How many people
- 80 participants
- Where
- 1 siteIreland
- Study dates
- 17 Nov 2021to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
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- Acute systemic infection or illness.
- Taking medication that affects cardiovascular function.
- Exclusion for any other reason deemed appropriate by the research team.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Heart Rate Response, Orthostasis
- Being tested
- Active Stand
- Keywords
- Heart rate response, Active Stand
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active StandDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Heart Rate
R-R interval is recorded by portable ECG throughout assessment
Measured: 60 seconds prior to standing assessment
Maximum heart rate
R-R interval is recorded by portable ECG throughout assessment
Measured: Within 3 minutes of standing assessment
Minimum heart rate
R-R interval is recorded by portable ECG throughout assessment
Measured: Within 3 minutes of standing assessment
Secondary outcomes (7)
Demographic data
gender, age, relevant past medical history
Measured: Day 1
Height
Centimeters
Measured: Day 1
Weight
Kilograms
Measured: Day 1
Body Mass Index
Kg/m^2
Measured: Day 1
Body Fat Percentage
Percentage
Measured: Day 1
Blood Pressure
Blood Pressure
Measured: At baseline
Vascular Stiffness
Pulse Wave Analysis conducted using the Mobil-O-Graph 24-hour Pulse Wave Analysis (PWA) system.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start17 Nov 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caitríona Quinn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caitríona Quinn, St. James's Hospital, Ireland
- Investigators
- John Gormley, PhD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921059
- Sponsor's protocol ID
- AS repeatability
- Status last verified
- May 2024
- First submitted
- 31 May 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared with outside parties.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols
- ClinicalTrials.gov ID
- NCT04921059
- Acronym / sponsor ID
- AS repeatability
- Conditions
- Heart Rate Response, Orthostasis
- Keywords
- Heart rate response, Active Stand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Caitríona QuinnUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active StandThe 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. | Diagnostic test | – |
Primary outcome
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
7 secondary outcomes
Demographic data
Time frame: Day 1
Height
Time frame: Day 1
Weight
Time frame: Day 1
Body Mass Index
Time frame: Day 1
Body Fat Percentage
Time frame: Day 1
Blood Pressure
Time frame: At baseline
Vascular Stiffness
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. Individual patient data will not be shared with outside parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gormley, PhD principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Response and Orthostasis, run by Caitríona Quinn at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Heart Rate (time frame: 60 seconds prior to standing assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.