validity, measurement feasibility and reliability in geriatric outpatients

Phase 2

Recruiting

Conditions: Aandoeningen van de bloeddrukregulatie
Orthostatic hypotension
fainting

Registration Number: NL-OMON48198

Lead Sponsor: Radboud Universiteit Nijmegen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 69

Inclusion Criteria

* Age: between 70 and 90 years
* Cognitive score as clinically assessed using Mini Mental State Examination
(MMSE): > 21 points out of 30.

Exclusion Criteria

Patients with the following conditions preventing them from performing the test
conditions will be excluded:
* Body mass index (BMI) > 35
* Neurological diseases causing inability to walk unassisted
* Musculoskeletal
o immobilization for 1 week during the last 3 months
o orthopedic surgery during the last 6 months
* Muscle disorders causing leg muscle weakness
* Any disorder causing chronic pain or pain during walking with pain score > 6
on scale from 1-10
* Severe vision problems, causing inability to walk unassisted
* General
o Acute infections affecting general condition
o Recent hospitalization (<4 weeks)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Baroreflex sensitivity and cerebral autoregulation in patients with symptoms,<br /><br>compared between those with and without OH<br /><br>- Baroreflex sensitivity and cerebral autoregulation in patients with OH,<br /><br>compared between those with and without symptoms<br /><br>- Collinearity between individual BRS, CAR and orthostatic BP drop magnitude<br /><br>measurements, separate for the three patient groups</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Accuracy of PPG based OH classification, separate for the three patient<br /><br>groups.<br /><br>- The Pearson correlation of PPG based BP estimation with the gold standard<br /><br>Finapres BP measurement between 0-30 seconds after standing up.<br /><br>- Patient reported convenience, using 1-10 scale.<br /><br>- The intraclass correlation coefficient of repeats of the same postural change<br /><br>in the same individual.</p><br>