Long COVID-19 Rehabilitation & Recovery Research Program

NCT05398692 | Terminated DMC

• 1 other identifier: 032588-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Keywords

Long COVID, COVID-19

Outcome Measures

Primary Outcomes (1)

• Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.

  Cardopulmonary - Exercise Outcomes.

  10 weeks

Secondary Outcomes (7)

• Short Form (SF-36)

  10 weeks

• Fatigue Severity Scale (FSS)

  10 weeks

• General Anxiety Disorder Screener (GAD-7)

  10 weeks

• Pittsburg Sleep Quality Score (PSQI)

  10 weeks

• Modified Medical Research Council Dyspnea Scale (mMRC)

  10 weeks

Study Arms (1)

+/- PEM

EXPERIMENTAL

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

Interventions

On Site Exercise Rehabilitation OTHER

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.

+/- PEM

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Related Publications (2)

• 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.

  PMID: 39337079 RESULT

• Abbasi A, Hansen N, Palade J, Paredes D, Meechoovet B, Van Keuren-Jensen K, Pirrotte P, Stringer WW. Serum extracellular vesicle RNA profiles in long COVID: insights from exercise-induced gene modulation. Sci Rep. 2026 Jan 26;16(1):3469. doi: 10.1038/s41598-025-23760-y.

  PMID: 41588020 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William W Stringer, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants receive on site low to intermediate intensity exercise rehabilitation.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: June 1, 2022
• Study Start: February 2, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)