Clinical trial NCT05398692: Long Haul COVID Rehabilitation & Recovery Research Program
Official title: Long Haul COVID Rehabilitation & Research Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.
timeFrame: 10 weeks
Secondary outcomes:
measure: Short Form (SF-36)
timeFrame: 10 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 10 weeks
measure: General Anxiety Disorder Screener (GAD-7)
timeFrame: 10 weeks
measure: C-Reactive Protein (CRP)
timeFrame: 10 weeks
measure: Pittsburg Sleep Quality Score (PSQI)
timeFrame: 10 weeks
measure: Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: 10 weeks
measure: Modified DePaul Assessment for Post-Exertional Malaise (DSQ-PEM)
timeFrame: 10 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
Study officials:
References: