Orthostatic HypotensionNCT05233865
Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension
A study testing Water exercise and Land exercise in people with Orthostatic Hypotension, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Water exercise and Land exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of dementia
- Contraindication for pool exercise (such as infected open wounds, fecal incontinence, diarrhea.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Aging Research Laboratory at UT Austin
Austin, Texas, 78712
About this study
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
- Being tested
- Water exercise, Land exercise
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water exerciseBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Land exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (mmHg)
Blood pressure will be taken with an automated blood pressure device
Measured: <1 minute upon standing
Diastolic blood pressure (mmHg)
Blood pressure will be taken with an automated blood pressure device
Measured: <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)
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start19 Oct 2021
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233865
- Sponsor's protocol ID
- STUDY00001869
- Status last verified
- Feb 2023
- First submitted
- 21 Oct 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make individual participant data available
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT05233865
- Acronym / sponsor ID
- STUDY00001869
- Conditions
- Orthostatic Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water condition | Experimental | Behavioral: Water exerciseParticipants 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. |
| Land condition | Active comparator | Behavioral: Land exerciseParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Diagnosis of dementia
- Contraindication for pool exercise (such as infected open wounds, fecal incontinence, diarrhea.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water exerciseParticipants 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. | Behavioural | Water condition |
| Land exerciseParticipants 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. | Behavioural | Land condition |
Primary outcome
Systolic blood pressure (mmHg)
Time frame: <1 minute upon standing
Blood pressure will be taken with an automated blood pressure device
Diastolic blood pressure (mmHg)
Time frame: <1 minute upon standing
Blood pressure will be taken with an automated blood pressure device
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make individual participant data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water exercise and Land exercise in people with Orthostatic Hypotension, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (mmHg) (time frame: <1 minute upon standing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.