Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Orthostatic Hypotension in Rehabilitation Patients

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: June 30, 2005
Last updated: March 18, 2016
Last verified: March 2016
The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical course of OH during their inpatient stay.

Condition Intervention
Hypotension, Orthostatic
Other: Treatment Phase 1
Drug: Treatment Phase 2
Other: Treatment Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Orthostatic Hypotension in Rehabilitation Patients

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Orthostatic Hypotension at Discharge [ Time Frame: Last three blood pressures prior to discharge ]
    Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension.

Enrollment: 341
Study Start Date: November 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment Phase 1
Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3)
Other: Treatment Phase 1
  • Patient Education
  • Physical Therapy Exercises
  • Increased Salt Intake
  • Elevation of head of bed with 2-4 inch wedge
  • Medication Review by MD, Pharma
Drug: Treatment Phase 2

Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1.

  • Fludrocortisone
  • Salt tablet
Other Name: Florinef
Other: Treatment Phase 3
Subjects still experiencing orthostatic hypotension after receiving Treatment Phases 1 and 2 move on to Treatment Phase 3. Individualized treatment is based on subspecialty or orthostatic hypotension consultation at the medical center. Subjects are followed for the duration of their hospital stay, on average 4 weeks.

Detailed Description:

This study is a prospective, quasi-experiment conducted in two consecutive phases. During the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. During the intervention phase, patients enrolled who have OH will receive the intervention. Patients will be enrolled over two research phases and the investigators expect to evaluate 459 subjects. This research program will occur over a three-year period.


During Phase I, baseline prevalence and natural history of OH will be determined by: enrolling consecutive appropriate subjects (able to stand, not end of life care) from a rehabilitation and nursing home unit and measuring OH 3 times weekly over their inpatient stay. In addition, chart review of diagnoses, medications, functional status, nutrition, and adverse events will be evaluated and correlated with clinical status. During Phase II, the investigators will implement a standardized, interdisciplinary (MD/RN/PT/Dietician) treatment plan for patients with OH. This will include chart review of diagnoses, medications, functional status, nutrition, adverse events, and correlation with clinical status. The goals of the interventions are to identify and treat the underlying causes of OH in rehabilitation patients. Based upon the comprehensive assessment, intervention participants will receive a standardized, interdisciplinary treatment regime.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admitted to Vancouver VA Nursing Home or Rehabilitation ward

Exclusion Criteria:

  • Unable to stand upon admission
  • Hospice admission
  • Respite admission
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00117585

United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA Office of Research and Development
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT00117585     History of Changes
Other Study ID Numbers: E3616-R
Study First Received: June 30, 2005
Results First Received: November 5, 2013
Last Updated: March 18, 2016

Keywords provided by VA Office of Research and Development:
Blood pressure

Additional relevant MeSH terms:
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases processed this record on May 22, 2017