Clinical trial NCT04797871: Resistance Training and Clinical Status in Patients With Post Discharge Symptoms After Covid-19
Official title: Resistance Training Intervention on the Clinical Status in Patients With Post Discharge Symptoms After Covid-19: The "EXER-COVID Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
SARS-CoV2
Fatigue Syndrome, Chronic
Stress, Psychological
Pain, Chronic
Lead sponsor: Universidad Pública de Navarra
Sponsor class: OTHER
Collaborators: name: Fundacion Miguel Servet
name: Complejo Hospitalario de Navarra
First posted: 2021-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: COVID-19 survivors commonly exhibit a marked extra-respiratory complication affecting the cardiac (arrhythmias and myocardial injury), renal (acute kidney injury), gastrointestinal, nervous (neuropathy, encephalopathy), endocrine and musculoskeletal (weakness, pain, and fatigue) systems. In this context, several studies have found that resistance training intervention promotes important health-related benefits, including cardiac function, compared to aerobic exercise training. Other exercise adaptations include increased skeletal muscle metabolism function, yet physio/psychological adaptations are known to be limited in COVID-19 survivors. Hence, given that resistance training intervention is implemented in a manner that is tolerable to the individual patient, it may be a potential beneficiary "personalized" rehabilitation treatment for patients with COVID-19 syndrome ambulatory.

The "EXER-COVID Clinical Study" project aims at determining the role of personalized exercise intervention in the treatment of post-COVID-19 syndrome ambulatory patients.

Detailed description: 100 patients will be recruited and undergo baseline testing, including examination, immune systems, biochemistry markers, ECG, DXA, metabolic/respiratory function, VO2max, muscular fitness, lipidomic/inflammatory/oxidative markers and psychological outcomes.

After baseline testing, participants will be randomly allocated into one group receiving standard of care (control group) or a group performing personalized resistance training intervention two times a week over a period of 6 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by an independent person. Following the 8-week intervention period (with a 1-week washout period), both groups will complete a series of follow-up tests (as baseline testing). A 12-week follow-up experimental day is also planned in order to evaluate physio/psychological changes.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* SARS-CoV-2 diagnosed using real-time reverse transcriptase polymerase chain reaction (PCR) tests or positive for SARS-CoV-2 virus antigen \>90 days before randomization.
* Still present a chronic symptomatic phase lasting \>90 days since debut of symptoms.
* Have not been hospitalized.
* There is no evidence on clinical records of pneumonia or any other organ failure related to SARS-CoV-2.
* Capable and willing to provide an informed consent.

Exclusion Criteria:

* Pregnancy or breast-feeding.
* Present atrial fibrillation.
* Diagnosed with acute myocarditis.
* Health conditions that prevent participating in the exercise intervention
* Patients who cannot undergo VO2max (e.g. acute heart attack or unstable angina, aortic stenosis, acute endocarditis / pericarditis, uncontrolled high blood pressure, acute thromboembolism, severe heart failure, respiratory failure and uncontrolled acute decompensated diabetes mellitus or low blood sugar).
* Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.

Primary outcomes:
measure: Changes in Cardiorespiratory fitness
timeFrame: Baseline, 6 Weeks and 12 Weeks
Secondary outcomes:
measure: Changes in Post-COVID manifestations
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in Blood samples analysed for markers related to low grade inflammation
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in pulse wave velocity
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in cardio-ankle vascular index (CAVI)
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in Energy expenditure
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in bone mineral density measured with DXA
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in fat mass measured with DXA
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in lean mass measured with DXA
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in Fat max oxidation rate
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in Dynamic and isometric strength
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in Axial accelerometer-based physical activity monitors
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in blood samples analysed for markers related to oxidative stress
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in serum metabolic profiles
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in creatinine kinase
timeFrame: Baseline
measure: Changes in total troponins levels (ng/mL)
timeFrame: Baseline
measure: Changes in D-dimer
timeFrame: Baseline
measure: Changes in thyroid function parameters
timeFrame: Baseline
measure: Changes in liver function
timeFrame: Baseline
measure: Changes in renal function
timeFrame: Baseline
measure: Changes in haematology parameters
timeFrame: Baseline
measure: Changes in cognitive status
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in visual attention and task switching
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in Quality of life
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in psychological stress
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in physical health symptomology
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in psychological distress
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in depressive symptomology
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in life satisfaction
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in resilience
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Change in pain score using numeric 0-10 rating scale
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Tracking the amount of exercise variety participants feel they engage in
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Changes in physical activity levels
timeFrame: Baseline, 6 Weeks and 12 Weeks
measure: Including Changes in mononuclear cells of peripheral blood (sub-sample 40 participants)
timeFrame: Baseline, 6 Weeks and 12 Weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Robinson Ramírez-Vélez, Ph.D
Study officials:
affiliation: Universidad Publica de Navarra
name: Mikel Izquierdo, Ph.D
role: STUDY_CHAIR
References:
citation: Ramirez-Velez R, Oteiza J, de Tejerina JMCF, Garcia-Alonso N, Legarra-Gorgonon G, Oscoz-Ochandorena S, Arasanz H, Garcia-Alonso Y, Correa-Rodriguez M, Izquierdo M. Resistance training and clinical status in patients with postdischarge symptoms after COVID-19: protocol for a randomized controlled crossover trial "The EXER-COVID Crossover Study". Trials. 2022 Aug 9;23(1):643. doi: 10.1186/s13063-022-06608-y.