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

NCT04921059 | Completed

• 1 other identifier: AS repeatability
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rate Response; Orthostasis

Keywords

Heart rate response; Active Stand

Outcome Measures

Primary Outcomes (3)

• 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 (7)

• Demographic data

  Day 1

• Height

  Day 1

• Weight

  Day 1

• Body Mass Index

  Day 1

• Body Fat Percentage

  Day 1

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Caitríona Quinn: lead

Study Sites (1)

Clinical Research Facility, St James's Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Gormley, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Physiotherapist

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 10, 2021
• Study Start: November 17, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: February 10, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)