Post-Acute COVID-19 SyndromeLC RehabNCT05398692
Long COVID-19 Rehabilitation & Recovery Research Program
A study testing On Site Exercise Rehabilitation in people with Post-Acute COVID-19 Syndrome and COVID-19, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, COVID-19
- What is being tested?
- On Site Exercise Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: 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).
Read the 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.
- Conditions
- Post-Acute COVID-19 Syndrome, COVID-19
- Being tested
- On Site Exercise Rehabilitation
- Keywords
- Long COVID, COVID-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On Site Exercise RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| +/- PEM | Experimental | Patients with and without Post Exertional Malaise (PEM) will receive 10 weeks of on site low to moderate intensity exercise rehabilitation. Receives: Other: On Site Exercise Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.
Cardopulmonary - Exercise Outcomes.
Measured: 10 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Modified Medical Research Council Dyspnea Scale (mMRC)
Score ranges from 0 to 4. Lower scores are better.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start2 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Funding exhausted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants receive on site low to intermediate intensity exercise rehabilitation.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Stringer, md, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- William W Stringer, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398692
- Sponsor's protocol ID
- 032588-01
- Acronym
- LC Rehab
- Status last verified
- Sep 2025
- First submitted
- 10 May 2022
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39337079Abbasi 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.
PubMed 41588020
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long COVID-19 Rehabilitation & Research Program
- ClinicalTrials.gov ID
- NCT05398692
- Acronym / sponsor ID
- LC Rehab / 032588-01
- Conditions
- Post-Acute COVID-19 Syndrome, COVID-19
- Keywords
- Long COVID, COVID-19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding exhausted.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants receive on site low to intermediate intensity exercise rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| +/- PEM | Experimental | Other: On Site Exercise RehabilitationPatients with and without Post Exertional Malaise (PEM) will receive 10 weeks of on site low to moderate intensity exercise rehabilitation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On Site Exercise RehabilitationThe 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. | Other | +/- PEM |
Primary outcome
Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.
Time frame: 10 weeks
Cardopulmonary - Exercise Outcomes.
7 secondary outcomes
Short Form (SF-36)
Time frame: 10 weeks
Fatigue Severity Scale (FSS)
Time frame: 10 weeks
General Anxiety Disorder Screener (GAD-7)
Time frame: 10 weeks
Pittsburg Sleep Quality Score (PSQI)
Time frame: 10 weeks
Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: 10 weeks
Modified DePaul Assessment for Post-Exertional Malaise (DSQ-PEM)
Time frame: 10 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: Funding exhausted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Results publication: PubMed 39337079Abbasi 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.
- Derived from this study: PubMed 41588020Abbasi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William W Stringer, MD principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On Site Exercise Rehabilitation in people with Post-Acute COVID-19 Syndrome and COVID-19, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding exhausted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398692, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.