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OpenTrials
Completed

NCT Number: NCT05233865

Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension

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.

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Key information

Conditions

Orthostatic Hypotension Autonomic Nervous System Diseases Cardiovascular Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Aging Research Laboratory at UT Austin

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Water exercise

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Systolic blood pressure (mmHg)

    Time frame: <1 minute upon standing

    Blood pressure will be taken with an automated blood pressure device

  2. Diastolic blood pressure (mmHg)

    Time frame: <1 minute upon standing

    Blood pressure will be taken with an automated blood pressure device

  3. Self-reported orthostatic hypotension symptoms

    Time frame: 2 minutes

    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)

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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