Evaluating non drug therapies in older people with orthostatic hypotensio

Not Applicable

Completed

• Conditions: Orthostatic hypotension (OH); Circulatory System

• Registration Number: ISRCTN15084870
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30558552 qualitative results (added 15/07/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30006412 quantitative results (added 15/07/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35286620/ quantitative results (added 15/03/2022) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31868889/ (added 04/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-20
• Study Completion: 2018-10-31
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Aged 60 years or above
2. Clinical diagnosis of orthostatic hypotension (confirmed with a postural drop in systolic/diastolic blood pressure of at least 20/10 mmHg within 3 minutes of standing upright from a supine position).
3. Able to stand upright

Exclusion Criteria

1. Age below 60 years
2. Dysphagia or previous episode of aspiration
3. Peripheral vascular disease or lower limb ulceration
4. Any contra-indication to bolus water drinking (such as a fluid restriction, cardiac/renal/liver failure)
5. Unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postural systolic blood pressure drop is measured using non-invasive, beat-to-beat monitoring (Taskforce Monitor, CNSystems) at baseline (before intervention) and then during each intervention (visit 1 and visit 2).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Postural diastolic blood pressure drop is measured using non-invasive, beat-to-beat monitoring (Taskforce Monitor, CNSystems) at baseline (before intervention) and then during each intervention (visit 1 and visit 2)<br> 2. Symptoms are measured using the Orthostatic Hypotension Questionnaire Symptom score at baseline and then immediately after orthostatic challenge with each intervention (visit 1 and 2)<br> 3. Acceptability of and barriers to therapy are measured using data from qualitative interviews at visit 3<br>