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Clinical Trials/NCT04921059
NCT04921059
Completed
Not Applicable

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

Caitríona Quinn1 site in 1 country80 target enrollmentNovember 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Rate Response
Sponsor
Caitríona Quinn
Enrollment
80
Locations
1
Primary Endpoint
Baseline Heart Rate
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 17, 2021
End Date
February 28, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Caitríona Quinn
Responsible Party
Sponsor Investigator
Principal Investigator

Caitríona Quinn

Research Physiotherapist

St. James's Hospital, Ireland

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Body Fat Percentage(Day 1)
  • Blood Pressure(At baseline)
  • Height(Day 1)
  • Weight(Day 1)
  • Demographic data(Day 1)
  • Body Mass Index(Day 1)
  • Vascular Stiffness(Day 1)

Study Sites (1)

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