Hemodynamic Effects of Aquatic vs. Land Exercise in Patients With Orthostatic Hypotension
Primary Purpose
Orthostatic Hypotension
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Orthostatic Hypotension focused on measuring aquatic therapy, aquatic exercise, orthostatic hypotension, blood pressure, heart rate, hemodynamics, land-based, inpatient rehabilitation,
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Central Texas Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aquatic Physical Therapy
Land-based Physical Therapy
Arm Description
Outcomes
Primary Outcome Measures
Hemodynamic variables - heart rate
heart rate
Hemodynamic variables - blood pressure
systolic blood pressure (SBP) and diastolic blood pressure (DBP) taken with a validated, automatic blood pressure recorder
Secondary Outcome Measures
Orthostatic Hypotension symptoms
Orthostatic Hypotension Questionnaire
Full Information
NCT ID
NCT04399486
First Posted
May 19, 2020
Last Updated
October 20, 2021
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT04399486
Brief Title
Hemodynamic Effects of Aquatic vs. Land Exercise in Patients With Orthostatic Hypotension
Official Title
Hemodynamic Effects of Aquatic vs. Land Exercise in Patients With Orthostatic Hypotension: a Randomized Controlled Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 and prolonged pool closure
Study Start Date
January 15, 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
Keywords
aquatic therapy, aquatic exercise, orthostatic hypotension, blood pressure, heart rate, hemodynamics, land-based, inpatient rehabilitation,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aquatic Physical Therapy
Arm Type
Experimental
Arm Title
Land-based Physical Therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemodynamic variables - heart rate
Description
heart rate
Time Frame
up to 3 hours
Title
Hemodynamic variables - blood pressure
Description
systolic blood pressure (SBP) and diastolic blood pressure (DBP) taken with a validated, automatic blood pressure recorder
Time Frame
up to 3 hours
Secondary Outcome Measure Information:
Title
Orthostatic Hypotension symptoms
Description
Orthostatic Hypotension Questionnaire
Time Frame
pre-post physical therapy intervention, 1 hour and 3 hours post physical therapy intervention
Other Pre-specified Outcome Measures:
Title
Characteristics of physical therapy session
Description
Evaluate percentage of time with sitting, standing, supine exercises vs resting.
Time Frame
during 60 min physical therapy session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Dunlap, PT
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Texas Rehabilitation Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Hemodynamic Effects of Aquatic vs. Land Exercise in Patients With Orthostatic Hypotension
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