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Completed

NCT Number: NCT04921059

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Facility, St James's Hospital

Dublin, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Caitríona Quinn

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2021
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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