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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05233865
Other study ID # STUDY00001869
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2021
Est. completion date February 10, 2023

Study information

Verified date February 2023
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to understand how blood pressure, heart rate, and symptoms of low blood pressure (such as dizziness or nausea) are affected by positional changes and exercise when on land or in the water for people who tend to experience orthostatic hypotension.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 10, 2023
Est. primary completion date February 10, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Self-report of dizziness upon standing (from sit or supine position) or known diagnosis of orthostatic hypotension - Able to stand independently for 3-5 consecutive minutes - Able to walk independently (with or without an assistive devise) - Medically stable for last month - Score of 3 or greater on Mini-Cog (standardized outcome measure to detect dementia) - Full coronavirus vaccination Exclusion Criteria: - Diagnosis of dementia - Contraindication for pool exercise (such as infected open wounds, fecal incontinence, diarrhea.)

Study Design


Intervention

Behavioral:
Water exercise
Participants will be asked to sit and stand multiple times (before, immediately after, and 2 hours after a 15-minute walking session). The walking session will consist of 3 minutes of walking at a light intensity followed by 9 min of walking at a moderate intensity and a 3-minute cool down walking at a light intensity. This walking session will occur in a pool.
Land exercise
Participants will be asked to sit and stand multiple times (before, immediately after, and 2 hours after a 15-minute walking session). The walking session will consist of 3 minutes of walking at a light intensity followed by 9 min of walking at a moderate intensity and a 3-minute cool down walking at a light intensity. This walking session will occur on land.

Locations

Country Name City State
United States Cardiovascular Aging Research Laboratory at UT Austin Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systolic blood pressure (mmHg) Blood pressure will be taken with an automated blood pressure device <1 minute upon standing
Primary Diastolic blood pressure (mmHg) Blood pressure will be taken with an automated blood pressure device <1 minute upon standing
Primary Self-reported orthostatic hypotension symptoms A self-reported instrument assessing symptoms from low blood pressure experienced upon standing or after prolonged upright activities. Possible scores range from 0 (no symptoms) to 10 (worse possible symptoms) 2 minutes
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