The purpose of the study is to assess the physiologic, immunologic, and mental healtheffects of a rehabilitation program on patients with Long Haul COVID (LHC).
1.0 Objectives 1.1 Describe the purpose, specific aims, or objectives.
The purpose is to assess the physiologic, immunologic, and mental health effects of a
rehabilitation program on patients with Long Haul COVID (LHC).
1.2 State the hypotheses to be tested.
Long Haul COVID Patients who enroll and complete a 10 week program of Physiologic and
Psychological Rehabilitation will have reduced Long Haul COVID Symptoms, Improved
Physical Status, Reduced Inflammatory Markers, and Augmented Psychological Well Being.
Other: Virtual vs On Site Pulmonary Rehabilitation
As part of the on site or virtual visits, the subject will receive standard pulmonary
rehabilitation educational instruction on balance and strength training, stretching,
nutrition, hydration, pacing, proper breathing, small or mini-lectures, and information
on relaxation techniques. If post exertional malaise is present, the patient will only
receive the educational sessions, no aerobic training.
Inclusion Criteria:
- Long Haul COVID Infection (Documented by PCR or patient report)
- Age >= 18 years old.
- At least 12 weeks since the initial COVID Infection.
- One or more of the following symptom/signs: Fatigue, Dyspnea, Exercise Intolerance,
Post Exertional Malaise and/or Difficulty Breathing.
- Able to perform a cardiopulmonary exercise test.
Exclusion Criteria:
- Patients is not able to perform technically acceptable pulmonary function tests and
symptom-limited cardiopulmonary cycle ergometry tests.
- Patients who desaturate to SpO2 <80% on screening incremental exercise testing.
- Patients who have completed a pulmonary rehabilitation program in the six weeks
prior to the screening visit or patients who are currently in a pulmonary
rehabilitation program.
- Patients who have taken an investigational drug within one month or six half-lives
(whichever is greater) prior to screening visit (Visit 1).
- Pregnant or nursing women.
- Women of childbearing potential who are not using a highly effective method of birth
control. Female patients will be considered of childbearing potential unless
surgically sterilized by hysterectomy or bilateral tubal ligation, or
post-menopausal for at least two years.
- Patients who are currently participating in another interventional study.
- Malignancy for which the patient has undergone resection, radiation therapy, or
chemotherapy within the last 2 years
- Any other significant disease than COVID which, in the opinion of the investigator,
may i) put the patient at risk because of participation in the study, ii) influence
the results of the study (e.g. Insulin or testosterone therapy, systemic
corticosteroids, HIV, etc), iii) cause concern regarding the patient's ability to
participate in the study.
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Investigator: William Stringer, MD
Contact: 424-571-7626
wstringer@labiomed.org
Investigator: William W Stringer, MD
William W Stringer, MD
424-571-7626
wstringer@lundquist.org
Leticia Diaz, MA
424-571-7258
ldiaz@lundquist.org
Not Provided