An Investigation of Heart Rate Recovery Responses to Repe... | NCT04921059

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

NCT04921059

Sponsor

Caitríona Quinn

Status

Completed

Last Update Posted

Feb 10, 2025Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Heart Rate Response
Orthostasis

Interventions

Active Stand

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2021Actual

Primary Completion Date

Feb 28, 2024Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

May 31, 2021

First Submission Date that Met QC Criteria

Jun 4, 2021

First Posted Date

Jun 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2025

Last Update Posted Date

Feb 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active Stand	Diagnostic 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.

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Demographic data	gender, age, relevant past medical history	Day 1
Height	Centimeters	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Gormley, PhD	University of Dublin, Trinity College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Facility, St James's Hospital		Dublin			Ireland

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual patient data will not be shared with outside parties.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004244	Dizziness

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided