Orthostatic HypotensionNCT04399486
Hemodynamic Effects of Aquatic vs. Land Exercise in Patients With Orthostatic Hypotension
A study testing Physical Therapy in people with Orthostatic Hypotension, run by University of Texas at Austin at 1 site in United States.
Trial summary
Orthostatic hypotension is a highly prevalent deficit in the aging population especially when coupled with stroke, frailty, diabetes, Parkinson's disease or spinal cord injuries. This population has difficulty with the autonomic regulation of blood pressure and experiences elevated risks of falls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at Central Texas Rehabilitation Hospital in Austin, Texas
- Age 18 years or older
- Patient presents with orthostatic hypotension defined as transitions from sit to stand using a threshold of drop of at least 15 mmHg for SBP or at least 7 mmHg for DBP.
- Aquatic therapeutic exercise is included in patients plan of care.
- Signed informed consent
Who cannot join
- Contraindication for aquatic physical therapy including but not limited to open wound that cannot be safely covered with a waterproof dressing, diarrhea, fever or know contagious infection.
- Unable to safely maintain standing position for 2 min with or without assistance to measure vitals in pool and land.
- Change in blood pressure medication or medical status between pool and land data collection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Texas Rehabilitation Hospital
Austin, Texas, 78751
About this study
Official title: Hemodynamic Effects of Aquatic vs. Land Exercise in Patients With Orthostatic Hypotension: a Randomized Controlled Crossover Trial
Orthostatic hypotension is a highly prevalent deficit in the aging population especially when coupled with stroke, frailty, diabetes, Parkinson's disease or spinal cord injuries. This population has difficulty with the autonomic regulation of blood pressure and experiences elevated risks of falls. The fall risk is greatest when the person transitions from supine or sitting to standing as this is when blood has a tendency to pool in the legs preventing adequate blood circulation to vital organs. This is a safety concern and limiting factor for rehabilitation of patients with orthostatic hypotension in the inpatient rehabilitation setting. There is low-quality evidence that compression garments such as abdominal binders and compression stockings can be helpful to manage orthostatic hypotension and the associated fall risk. However, many people with orthostatic hypotension perceive the treatment approach with compression stockings to be largely unacceptable.
Aquatic immersion may provide better advantages to compression garments because hydrostatic pressure exerts a little over 22 mmHg pressure for every foot of water. Therefore, an individual standing in 4 ft depth water will have roughly 90 mmHg pressure on their feet and about 56 mmHg at their knees. These amounts of pressure are more than those induced by typical compression stockings, which provide 30-40 mm Hg pressure. In addition, immersion at level of xiphoid process or higher is known to translocate blood from the lower to the center of the body and act to increase cerebral blood flow which may be beneficial for preventing orthostatic hypotension symptoms.
Read more
No studies have looked at the physiologic response to immersion and aquatic exercise for people with orthostatic hypotension. Since this population is known to have difficulty with autonomic regulation of blood pressure, it is unclear if they will experience a similar hemodynamic response during immersion than the healthy population during or after aquatic therapy due to orthostatic hypotension.
Anecdotal evidence suggests that patients with orthostatic hypotension do not exhibit adverse effects due to orthostatic hypotension when standing in water or participating in aquatic exercise independent of compression garments use. They often have improved standing tolerance in the pool compared with prolonged standing on land. Steps to manage orthostatic hypotension when out of the pool, such as hydration during pool session, placing compressive garments prior to exit of pool and slow transitions out of pool setting has been adequate to prevent symptoms of orthostatic hypotension in the post exercise period in this population.
The primary aim of this study is to look at heart rate and blood pressure response when going from sit to stand during physical therapy sessions on land compared to in the pool for people who have orthostatic hypotension (defined as a drop in systolic blood pressure of at least 15 mmHg or 7 mmHg drop in diastolic blood pressure from sitting to standing). The secondary aim of this study is to evaluate tolerance for physical activity during physical therapy sessions in the pool compared to on land for people with orthostatic hypotension. The third aim of the study is to investigate heart rate and blood pressure response for 3 hours following the physical therapy sessions.
We hypothesize that orthostatic hypotension will be reduced and standing exercise tolerance will be increased when in the pool compared to on land. In addition, we hypothesized that there will not be a significant difference in heart rate or blood pressure response in the 3-hour post exercise period of aquatic vs. land exercise.
- Conditions
- Orthostatic Hypotension
- Being tested
- Physical Therapy
- Keywords
- aquatic therapy, aquatic exercise, orthostatic hypotension, blood pressure, heart rate, hemodynamics, land-based, inpatient rehabilitation,
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Physical Therapy is a therapeutic exercise, education and functional activities provided on a one to one basis with a licensed Physical Therapist to meet functional goals.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Physical Therapy | Experimental | Not described Receives: Other: Physical Therapy |
| Land-based Physical Therapy | Active comparator | Not described Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic variables - heart rate
heart rate
Measured: up to 3 hours
Hemodynamic variables - blood pressure
systolic blood pressure (SBP) and diastolic blood pressure (DBP) taken with a validated, automatic blood pressure recorder
Measured: up to 3 hours
Secondary outcomes (1)
Orthostatic Hypotension symptoms
Orthostatic Hypotension Questionnaire
Measured: pre-post physical therapy intervention, 1 hour and 3 hours post physical therapy intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start15 Jan 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: COVID-19 and prolonged pool closure
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Dunlap, University of Texas at Austin
- Investigators
- Emily Dunlap, PT, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399486
- Sponsor's protocol ID
- 2019-11-0112
- Status last verified
- Oct 2021
- First submitted
- 19 May 2020
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Aquatic vs. Land Exercise in Patients With Orthostatic Hypotension: a Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT04399486
- Acronym / sponsor ID
- 2019-11-0112
- Conditions
- Orthostatic Hypotension
- Keywords
- aquatic therapy, aquatic exercise, orthostatic hypotension, blood pressure, heart rate, hemodynamics, land-based, inpatient rehabilitation,
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 and prolonged pool closure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 May 2020 (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.
Orthostatic hypotension is a highly prevalent deficit in the aging population especially when coupled with stroke, frailty, diabetes, Parkinson's disease or spinal cord injuries. This population has difficulty with the autonomic regulation of blood pressure and experiences elevated risks of falls. The fall risk is greatest when the person transitions from supine or sitting to standing as this is when blood has a tendency to pool in the legs preventing adequate blood circulation to vital organs. This is a safety concern and limiting factor for rehabilitation of patients with orthostatic hypotension in the inpatient rehabilitation setting. There is low-quality evidence that compression garments such as abdominal binders and compression stockings can be helpful to manage orthostatic hypotension and the associated fall risk. However, many people with orthostatic hypotension perceive the treatment approach with compression stockings to be largely unacceptable.
Aquatic immersion may provide better advantages to compression garments because hydrostatic pressure exerts a little over 22 mmHg pressure for every foot of water. Therefore, an individual standing in 4 ft depth water will have roughly 90 mmHg pressure on their feet and about 56 mmHg at their knees. These amounts of pressure are more than those induced by typical compression stockings, which provide 30-40 mm Hg pressure. In addition, immersion at level of xiphoid process or higher is known to translocate blood from the lower to the center of the body and act to increase cerebral blood flow which may be beneficial for preventing orthostatic hypotension symptoms.
No studies have looked at the physiologic response to immersion and aquatic exercise for people with orthostatic hypotension. Since this population is known to have difficulty with autonomic regulation of blood pressure, it is unclear if they will experience a similar hemodynamic response during immersion than the healthy population during or after aquatic therapy due to orthostatic hypotension.
Anecdotal evidence suggests that patients with orthostatic hypotension do not exhibit adverse effects due to orthostatic hypotension when standing in water or participating in aquatic exercise independent of compression garments use. They often have improved standing tolerance in the pool compared with prolonged standing on land. Steps to manage orthostatic hypotension when out of the pool, such as hydration during pool session, placing compressive garments prior to exit of pool and slow transitions out of pool setting has been adequate to prevent symptoms of orthostatic hypotension in the post exercise period in this population.
The primary aim of this study is to look at heart rate and blood pressure response when going from sit to stand during physical therapy sessions on land compared to in the pool for people who have orthostatic hypotension (defined as a drop in systolic blood pressure of at least 15 mmHg or 7 mmHg drop in diastolic blood pressure from sitting to standing). The secondary aim of this study is to evaluate tolerance for physical activity during physical therapy sessions in the pool compared to on land for people with orthostatic hypotension. The third aim of the study is to investigate heart rate and blood pressure response for 3 hours following the physical therapy sessions.
We hypothesize that orthostatic hypotension will be reduced and standing exercise tolerance will be increased when in the pool compared to on land. In addition, we hypothesized that there will not be a significant difference in heart rate or blood pressure response in the 3-hour post exercise period of aquatic vs. land exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic Physical Therapy | Experimental | Other: Physical Therapy |
| Land-based Physical Therapy | Active comparator | Other: Physical Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient at Central Texas Rehabilitation Hospital in Austin, Texas
- Age 18 years or older
- Patient presents with orthostatic hypotension defined as transitions from sit to stand using a threshold of drop of at least 15 mmHg for SBP or at least 7 mmHg for DBP.
- Aquatic therapeutic exercise is included in patients plan of care.
- Signed informed consent
Key exclusion criteria (3 listed)
- Contraindication for aquatic physical therapy including but not limited to open wound that cannot be safely covered with a waterproof dressing, diarrhea, fever or know contagious infection.
- Unable to safely maintain standing position for 2 min with or without assistance to measure vitals in pool and land.
- Change in blood pressure medication or medical status between pool and land data collection.
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 |
|---|---|---|
| Physical TherapyPhysical Therapy is a therapeutic exercise, education and functional activities provided on a one to one basis with a licensed Physical Therapist to meet functional goals. | Other | Aquatic Physical Therapy, Land-based Physical Therapy |
Primary outcome
Hemodynamic variables - heart rate
Time frame: up to 3 hours
heart rate
Hemodynamic variables - blood pressure
Time frame: up to 3 hours
systolic blood pressure (SBP) and diastolic blood pressure (DBP) taken with a validated, automatic blood pressure recorder
1 secondary outcome
Orthostatic Hypotension symptoms
Time frame: pre-post physical therapy intervention, 1 hour and 3 hours post physical therapy intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Orthostatic Hypotension
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Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
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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.
Emily Dunlap, PT principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 Oct 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hemodynamic variables - heart rate (time frame: up to 3 hours). The study lists 2 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 28 Oct 2021.