Long COVID-19 Rehabilitation & Recovery Research Program (LC Rehab)

Long COVID-19 Rehabilitation & Research Program

The purpose of the study is to assess the physiologic, immunologic, and mental health effects of an exercise and pulmonary rehabilitation program on patients with Long COVID-19 (LC).

Study Overview

• Status: Terminated
• Conditions: COVID-19; Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Other: On Site Exercise Rehabilitation

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 COVID-19 (LHC).

1.2 State the hypotheses to be tested.

Long COVID-19 Patients who enroll and complete a 10 week program of Physiologic and Psychological Rehabilitation will have reduced Long COVID-19 Symptoms, Improved Physical Status, Reduced Inflammatory Markers, and Augmented Psychological Well Being.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90509
      • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Long COVID-19 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-19 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: +/- PEM; Patients with and without Post Exertional Malaise (PEM) will receive 10 weeks of on site low to moderate intensity exercise rehabilitation.	Other: On Site Exercise Rehabilitation; The subject will receive on site standard pulmonary and exercise rehabilitation, educational instruction on balance and strength training, stretching, nutrition, hydration, pacing, proper breathing, small or mini-lectures, and information on relaxation techniques.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Investigators: Principal Investigator: William W Stringer, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Publications and helpful links

General Publications

• Abbasi A, Gattoni C, Iacovino M, Ferguson C, Tosolini J, Singh A, Soe KK, Porszasz J, Lanks C, Rossiter HB, Casaburi R, Stringer WW. A Pilot Study on the Effects of Exercise Training on Cardiorespiratory Performance, Quality of Life, and Immunologic Variables in Long COVID. J Clin Med. 2024 Sep 20;13(18):5590. doi: 10.3390/jcm13185590.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 28, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Long COVID, COVID-19
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 032588-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No