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.

Study Overview

• Status: Completed
• Conditions: Orthostatic Hypotension
• Intervention / Treatment: Behavioral: Water exercise; Behavioral: Land exercise

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Cardiovascular Aging Research Laboratory at UT Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water condition; 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.	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.
Active Comparator: Land condition; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (mmHg)	Blood pressure will be taken with an automated blood pressure device	<1 minute upon standing
Diastolic blood pressure (mmHg)	Blood pressure will be taken with an automated blood pressure device	<1 minute upon standing
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

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Hypotension; Hypotension, Orthostatic
• Other Study ID Numbers: STUDY00001869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make individual participant data available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No