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

NCT ID: NCT04921059

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2024-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Active Stand

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.

Intervention Type: DIAGNOSTIC_TEST

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Caitríona Quinn

OTHER

Sponsor Role: lead

Responsible Party

Caitríona Quinn

Research Physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Gormley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

Clinical Research Facility, St James's Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

AS repeatability

Identifier Type: -

Identifier Source: org_study_id