Long Haul COVID Rehabilitation & Recovery Research Program

Not Applicable

Recruiting

• Conditions: Post-Acute COVID-19 Syndrome

• Registration Number: NCT05398692
• Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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).

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 Timeline

• Study Start: 2022-02-02
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-28
• Study First Posted: 2022-06-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-02-02
• Study Completion: 2025-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.	10 weeks	Cardopulmonary - Exercise Outcomes.

Secondary Outcome Measures

Name	Time	Method
Pittsburg Sleep Quality Score (PSQI)	10 weeks	Change in Sleep Quality Index - Scores from 0 to 42. Lower scores are better. A score \> 5 indicates poor sleep quality.
Fatigue Severity Scale (FSS)	10 weeks	Change in a Fatigue Score - 9 questions -1 (strongly disagree) to 7 (strongly agree). Total score from 7 to 54. Lower numbers are better.
Patient Health Questionnaire (PHQ-9)	10 weeks	Change in Depression scores - 9 questions that are scored from 0-3. Total scores 0-27. Lower scores are better.
Modified Medical Research Council Dyspnea Scale (mMRC)	10 weeks	Score ranges from 0 to 4. Lower scores are better.
Modified DePaul Assessment for Post-Exertional Malaise (DSQ-PEM)	10 weeks	Questions 6-10 Specific to PEM. All questions are Yes/No, No is best.
Short Form (SF-36)	10 weeks	Quality of Life - 36 Item Short Form Survey. 8 subdomains - Potential scores 0 to 100 (100 being best) in each domain.
General Anxiety Disorder Screener (GAD-7)	10 weeks	Change in Anxiety scores - 7 questions. 0-Not at all to 3 Nearly Every Day - Scores from 0-21. Lower numbers are better.
C-Reactive Protein (CRP)	10 weeks	Normal Range \< 8 mg/L Lower numbers are better.

Trial Locations

Locations (1)

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States