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Long Haul COVID Rehabilitation & Recovery Research Program (LHC Rehab)

Primary Purpose

Long Haul COVID or Post Acute Sequella of COVID - PASC (U09.9)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual vs On Site Pulmonary Rehabilitation
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long Haul COVID or Post Acute Sequella of COVID - PASC (U09.9)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

+ PEM

No PEM

Arm Description

Patients who experience Post Exertional Malaise (PEM) will receive 10 weeks of virtual rehabilitation.

Patients who do not experience Post Exertional Malaise (PEM) will receive 10 weeks of traditional pulmonary rehabilitation.

Outcomes

Primary Outcome Measures

Change in aerobic capacity (Peak Oxygen Uptake, Anaerobic Threshold and Maximum Work rate) at 10 weeks after a comprehensive (normal intensity) pulmonary rehabilitation program.
Exercise, Immunologic, and Neuropsychiatric Outcomes.

Secondary Outcome Measures

Change in General Quality of Life
SF-36
Change in a Fatigue Score
Fatigue Severity Score questionnaire
Change in Anxiety scores
General Anxiety Disorder Screener (GAD-7)
Change in the Inflammatory Cytokines .
CRP, Ferritin, D-Dimer, IL-6, IL-10, IL2, TNF-alpha, and INF-gamma
Change in Sleep Quality Index
Pittsburg Sleep Quality Score (PSQI)
Change in a Dyspnea score.
Modified Medical Research Council Dyspnea Scale (mMRC)
Change in a Post Exertional Malaise score.
Modified DePaul Assessment for Post-Exertional Malaise
Change in Depression scores
Patient Health Questionnaire (PHQ-9)

Full Information

First Posted
May 10, 2022
Last Updated
May 28, 2022
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05398692
Brief Title
Long Haul COVID Rehabilitation & Recovery Research Program
Acronym
LHC Rehab
Official Title
Long Haul COVID Rehabilitation Research Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
February 2, 2025 (Anticipated)
Study Completion Date
February 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Haul COVID or Post Acute Sequella of COVID - PASC (U09.9)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: Post exertional Malaise (PEM) present who will receive virtual low intensity rehabilitation. No Post Exertional Malaise group (no PEM) who will receive 10 weeks of traditional pulmonary rehabiltiation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
+ PEM
Arm Type
Active Comparator
Arm Description
Patients who experience Post Exertional Malaise (PEM) will receive 10 weeks of virtual rehabilitation.
Arm Title
No PEM
Arm Type
Experimental
Arm Description
Patients who do not experience Post Exertional Malaise (PEM) will receive 10 weeks of traditional pulmonary rehabilitation.
Intervention Type
Other
Intervention Name(s)
Virtual vs On Site Pulmonary Rehabilitation
Intervention Description
As part of the on site or virtual visits, the subject will receive standard pulmonary rehabilitation educational instruction on balance and strength training, stretching, nutrition, hydration, pacing, proper breathing, small or mini-lectures, and information on relaxation techniques. If post exertional malaise is present, the patient will only receive the educational sessions, no aerobic training.
Primary Outcome Measure Information:
Title
Change in aerobic capacity (Peak Oxygen Uptake, Anaerobic Threshold and Maximum Work rate) at 10 weeks after a comprehensive (normal intensity) pulmonary rehabilitation program.
Description
Exercise, Immunologic, and Neuropsychiatric Outcomes.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in General Quality of Life
Description
SF-36
Time Frame
10 weeks
Title
Change in a Fatigue Score
Description
Fatigue Severity Score questionnaire
Time Frame
10 weeks
Title
Change in Anxiety scores
Description
General Anxiety Disorder Screener (GAD-7)
Time Frame
10 weeks
Title
Change in the Inflammatory Cytokines .
Description
CRP, Ferritin, D-Dimer, IL-6, IL-10, IL2, TNF-alpha, and INF-gamma
Time Frame
10 weeks
Title
Change in Sleep Quality Index
Description
Pittsburg Sleep Quality Score (PSQI)
Time Frame
10 weeks
Title
Change in a Dyspnea score.
Description
Modified Medical Research Council Dyspnea Scale (mMRC)
Time Frame
10 weeks
Title
Change in a Post Exertional Malaise score.
Description
Modified DePaul Assessment for Post-Exertional Malaise
Time Frame
10 weeks
Title
Change in Depression scores
Description
Patient Health Questionnaire (PHQ-9)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William W Stringer, MD
Phone
424-571-7626
Email
wstringer@lundquist.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leticia Diaz, MA
Phone
424-571-7258
Email
ldiaz@lundquist.org
Facility Information:
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Stringer, MD
Phone
424-571-7626
Email
wstringer@labiomed.org
First Name & Middle Initial & Last Name & Degree
Leticia Diaz, RN
Phone
310-222-8022
Ext
7258
Email
ldiaz@labiomed.org
First Name & Middle Initial & Last Name & Degree
William W Stringer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Long Haul COVID Rehabilitation & Recovery Research Program

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