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

Primary Purpose

Orthostatic Hypotension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water exercise
Land exercise
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Orthostatic Hypotension

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Cardiovascular Aging Research Laboratory at UT Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Water condition

Land condition

Arm Description

Participants blood pressure, heart rate and self-reported symptoms (such as dizziness) will be collected multiple times during sitting, standing and walking conditions when in a pool.

Participants blood pressure, heart rate and self-reported symptoms (such as dizziness) will be collected multiple times during sitting, standing, and walking conditions when on land.

Outcomes

Primary Outcome Measures

Systolic blood pressure (mmHg)
Blood pressure will be taken with an automated blood pressure device
Diastolic blood pressure (mmHg)
Blood pressure will be taken with an automated blood pressure device
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)

Secondary Outcome Measures

Full Information

First Posted
October 21, 2021
Last Updated
February 27, 2023
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05233865
Brief Title
Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension
Official Title
Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water condition
Arm Type
Experimental
Arm Description
Participants blood pressure, heart rate and self-reported symptoms (such as dizziness) will be collected multiple times during sitting, standing and walking conditions when in a pool.
Arm Title
Land condition
Arm Type
Active Comparator
Arm Description
Participants blood pressure, heart rate and self-reported symptoms (such as dizziness) will be collected multiple times during sitting, standing, and walking conditions when on land.
Intervention Type
Behavioral
Intervention Name(s)
Water exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Land exercise
Intervention Description
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 Outcome Measure Information:
Title
Systolic blood pressure (mmHg)
Description
Blood pressure will be taken with an automated blood pressure device
Time Frame
<1 minute upon standing
Title
Diastolic blood pressure (mmHg)
Description
Blood pressure will be taken with an automated blood pressure device
Time Frame
<1 minute upon standing
Title
Self-reported orthostatic hypotension symptoms
Description
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)
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Cardiovascular Aging Research Laboratory at UT Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make individual participant data available

Learn more about this trial

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

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