Long Haul COVID Rehabilitation & Recovery Research Program
Purpose
The purpose of the study is to assess the physiologic, immunologic, and mental health effects of a rehabilitation program on patients with Long Haul COVID (LHC).
Condition
- Post-Acute COVID-19 Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Two groups: 1. Post exertional Malaise (PEM) present who will receive virtual low intensity rehabilitation. 2. No Post Exertional Malaise group (no PEM) who will receive 10 weeks of traditional pulmonary rehabiltiation.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator + PEM |
Patients who experience Post Exertional Malaise (PEM) will receive 10 weeks of virtual rehabilitation. |
|
|
Experimental No PEM |
Patients who do not experience Post Exertional Malaise (PEM) will receive 10 weeks of traditional pulmonary rehabilitation. |
|
Recruiting Locations
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90509
Torrance, California 90509
More Details
- NCT ID
- NCT05398692
- Status
- Recruiting
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Detailed Description
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.