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

NCT05233865 | Completed

• 1 other identifier: STUDY00001869
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Hypotension

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Water condition

EXPERIMENTAL

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

Land condition

ACTIVE COMPARATOR

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

Interventions

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.

Water condition

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.

Land condition

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of dementia
• Contraindication for pool exercise (such as infected open wounds, fecal incontinence, diarrhea.)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Cardiovascular Aging Research Laboratory at UT Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: February 10, 2022
• Study Start: October 19, 2021
• Primary Completion: February 10, 2023
• Study Completion: February 10, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

US (1)