Clinical trial NCT04921059: An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols
Official title: An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate Response
Orthostasis
Keywords: Heart rate response
Active Stand
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: Baseline Heart Rate
timeFrame: 60 seconds prior to standing assessment
measure: Maximum heart rate
timeFrame: Within 3 minutes of standing assessment
measure: Minimum heart rate
timeFrame: Within 3 minutes of standing assessment
Secondary outcomes:
measure: Demographic data
timeFrame: Day 1
measure: Height
timeFrame: Day 1
measure: Weight
timeFrame: Day 1
measure: Body Mass Index
timeFrame: Day 1
measure: Body Fat Percentage
timeFrame: Day 1
measure: Blood Pressure
timeFrame: At baseline
measure: Vascular Stiffness
timeFrame: Day 1
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Clinical Research Facility, St James's Hospital
Study officials:
affiliation: University of Dublin, Trinity College
name: John Gormley, PhD
role: PRINCIPAL_INVESTIGATOR
References: