Long COVID, Long Covid19, Long Covid-19
Conditions
Keywords
PASC, Exercise, PEM (post exertional malaise)
Brief summary
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.
Detailed description
Study interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix. Study intervention appendices may be added or removed according to adaptive design and/or emerging evidence. The platform protocol enrolls participants who meet study eligibility criteria. After completing initial screening assessments, eligible participants are assigned to one of the study intervention appendices that are actively enrolling. Participants must meet certain criteria within a specific appendix in order to be included in that appendix. Once assigned to an appendix, eligible participants are randomized to either the study intervention group or a control group.
Interventions
Participants in this group will complete 2-3 cardiopulmonary rehabilitation sessions per week, for 12 weeks, as tolerated. Rehabilitation sessions are provided by respiratory therapists, exercise physiologists, physical therapists, nurses, or others who have experience and training in either pulmonary or cardiac rehabilitation. Rehabilitation sessions (adjusted based on the participant's baseline assessment, symptoms, and progress) last about 1 hour and include education, aerobic exercise, strength, and flexibility training.
OTHEREducation
Participants in this group will receive two general education sessions at the start of the intervention with weekly phone/virtual follow-ups from site study staff.
Sponsors
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor of the primary outcome, Endurance Shuttle Walk Test (ESWT), is blinded.
Intervention model description
This platform protocol is designed to allocate participants into an appropriate intervention appendix based on their symptoms of exercise intolerance. Once assigned to an appendix, eligible participants are randomized in a 1:1 ratio to either the study intervention group or a control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and
Exclusion criteria
which applies to this appendix Additional Appendix A (Cardiopulmonary Rehabilitation (Exercise Intolerance)) Level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Endurance Shuttle Walk Test (ESWT) | Baseline, week 12 (End of Intervention (EOI)) | The ESWT consists of timed walking on a 10m course. The result is expressed as total walking time after an initial 2-minute warm-up. The ESWT is an outcome measure of exercise capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical function, as measured by the PROMIS SF-Physical Function (PROMIS-PF) | Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS) | The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. |
| Change in physical function, as measured by actigraphy | Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS) | — |
| Change in symptom frequency, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM) | Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS) | Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. |
| Change in symptom severity, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM) | Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS) | Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. |
| Change in symptom duration, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM) | Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS) | — |
Countries
United States
Contacts
STUDY_CHAIRGary M Felker, MD
Duke Clinical Research Institute
STUDY_CHAIRBarry Make, MD
National Jewish Health
STUDY_CHAIRLucinda Bateman, MD
Bateman Horne Center
STUDY_CHAIRJanna Friedly, MD, MPH
University of Washington
Outcome results
None listed