LHC Rehab: Long Haul COVID Rehabilitation & Recovery Research Program
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: + PEM Patients who experience Post Exertional Malaise (PEM) will receive 10 weeks of virtual rehabilitation. |
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.
|
| Experimental: No PEM Patients who do not experience Post Exertional Malaise (PEM) will receive 10 weeks of traditional pulmonary rehabilitation. |
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.
|
Outcome Measures
Primary Outcome Measures
- Change in aerobic capacity (Peak Oxygen Uptake, Anaerobic Threshold and Maximum Work rate) at 10 weeks after a comprehensive (normal intensity) pulmonary rehabilitation program. [10 weeks]
Exercise, Immunologic, and Neuropsychiatric Outcomes.
Secondary Outcome Measures
- Change in General Quality of Life [10 weeks]
SF-36
- Change in a Fatigue Score [10 weeks]
Fatigue Severity Score questionnaire
- Change in Anxiety scores [10 weeks]
General Anxiety Disorder Screener (GAD-7)
- Change in the Inflammatory Cytokines . [10 weeks]
CRP, Ferritin, D-Dimer, IL-6, IL-10, IL2, TNF-alpha, and INF-gamma
- Change in Sleep Quality Index [10 weeks]
Pittsburg Sleep Quality Score (PSQI)
- Change in a Dyspnea score. [10 weeks]
Modified Medical Research Council Dyspnea Scale (mMRC)
- Change in a Post Exertional Malaise score. [10 weeks]
Modified DePaul Assessment for Post-Exertional Malaise
- Change in Depression scores [10 weeks]
Patient Health Questionnaire (PHQ-9)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Long Haul COVID Infection (Documented by PCR or patient report)
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Age >= 18 years old.
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At least 12 weeks since the initial COVID Infection.
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One or more of the following symptom/signs: Fatigue, Dyspnea, Exercise Intolerance, Post Exertional Malaise and/or Difficulty Breathing.
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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.
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Patients who desaturate to SpO2 <80% on screening incremental exercise testing.
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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.
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Patients who have taken an investigational drug within one month or six half-lives (whichever is greater) prior to screening visit (Visit 1).
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Pregnant or nursing women.
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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.
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Patients who are currently participating in another interventional study.
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Malignancy for which the patient has undergone resection, radiation therapy, or chemotherapy within the last 2 years
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | United States | 90509 |
Sponsors and Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 032588-01