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

Completed

• Conditions: Heart Rate Response; Orthostasis

• Registration Number: NCT04921059
• Lead Sponsor: Caitríona Quinn

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 available

Study Timeline

• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-10
• Study Start: 2021-11-17
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline Heart Rate	60 seconds prior to standing assessment	R-R interval is recorded by portable ECG throughout assessment
Maximum heart rate	Within 3 minutes of standing assessment	R-R interval is recorded by portable ECG throughout assessment
Minimum heart rate	Within 3 minutes of standing assessment	R-R interval is recorded by portable ECG throughout assessment

Secondary Outcome Measures

Name	Time	Method
Weight	Day 1	Kilograms
Demographic data	Day 1	gender, age, relevant past medical history
Body Mass Index	Day 1	Kg/m\^2
Height	Day 1	Centimeters
Vascular Stiffness	Day 1	Pulse Wave Analysis conducted using the Mobil-O-Graph 24-hour Pulse Wave Analysis (PWA) system.
Body Fat Percentage	Day 1	Percentage
Blood Pressure	At baseline	Blood Pressure

Trial Locations

Locations (1)

Clinical Research Facility, St James's Hospital; 🇮🇪 Dublin, Ireland