Resistance Training and Clinical Status in Patients With Post Discharge Symptoms After Covid-19
- Conditions
- SARS-CoV2Covid19Stress, PsychologicalFatigue Syndrome, ChronicPain, Chronic
- Interventions
- Behavioral: Standard careBehavioral: Resistance training
- Registration Number
- NCT04797871
- Lead Sponsor
- Universidad Pública de Navarra
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard care Standard care Non-supervised ACSM exercise guidelines Exercise Resistance training Resistance training
- Primary Outcome Measures
Name Time Method Changes in Cardiorespiratory fitness Baseline, 6 Weeks and 12 Weeks Measured with an incremental VO2 protocol on exercise bike by COSMED Quark CPET plus OMNIA (COSMED®, Rome, Italy)
- Secondary Outcome Measures
Name Time Method Changes in cardio-ankle vascular index (CAVI) Baseline, 6 Weeks and 12 Weeks Measuring Cardio-Ankle Vascular Index (%) by VaSera VS 2000 (Fukuda Denshi, Japan)
Changes in Energy expenditure Baseline, 6 Weeks and 12 Weeks Measuring by COSMED Q-NRG+ plus OMNIA (COSMED®, Rome, Italy)
Changes in bone mineral density measured with DXA Baseline, 6 Weeks and 12 Weeks Measuring in bone mineral density (g)
Changes in total troponins levels (ng/mL) Baseline Total troponins levels (ng/mL)
Changes in liver function Baseline ALT in (U/L), AST and GGT in (U/L)
Changes in renal function Baseline Urea (mmol/L), sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), calcium (mmol/L), inorganic phosphorus (mmol/L) and uric acid (mmol/L)
Changes in haematology parameters Baseline White Blood Cells and Red Blood Cells (cell characterization)
Changes in Axial accelerometer-based physical activity monitors Baseline, 6 Weeks and 12 Weeks Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK)
Changes in blood samples analysed for markers related to oxidative stress Baseline, 6 Weeks and 12 Weeks Including catalase, glutathione peroxidase, peroxidase, glutathione reductase in arbitrary units.
Changes in serum metabolic profiles Baseline, 6 Weeks and 12 Weeks Utrahigh-performance liquid chromatography (UHPLC)-time of flight-MS based platforms analyzing methanol and chloroform/methanol serum extracts will be combined with the lipids measurement using an UHPLC-single quadrupole-MS based analysis in arbitrary units. Explained fraction of variance and the goodness of prediction will be calculated.
Changes in psychological stress Baseline, 6 Weeks and 12 Weeks The 1 Item Statistics Canada Stress Question (SCSQ) will be used. The SCSQ is a 1-item question with a possible scoring of 0 to 10, with higher scores indicating more stress.
Changes in physical health symptomology Baseline, 6 Weeks and 12 Weeks A Physical Health item will be used in the baseline. The scoring range is 0-13, with higher numbers indicating experiencing more negative physical health symptoms.
Changes in depressive symptomology Baseline, 6 Weeks and 12 Weeks The 10 Item Center for Epidemiologic Studies Depression Scale (CES-D) will be used in the baseline survey, and will be in each weekly survey to track changes in the CES-D over the study period. The possible range in scores is 0 to 30 depending on number of symptoms, with those symptoms weighted by frequency experienced in a week. Higher scores indicating more or more frequent symptoms.
Changes in Post-COVID manifestations Baseline, 6 Weeks and 12 Weeks Questionnaires that sought information about symptoms related to COVID-19 will be administrate. It is a dichotomous scale (Yes/No), that reflects symptoms, functional limitations, and clinical characteristics (i.e., nausea/vomiting, impaired visual acuity or blurry vision, anosmia, dizziness, depression, chills, weakness, musculoskeletal pain, palpitations/tachycardia, change of appetite, frustration, cognitive involvement, anxiety/irritability, dryness, impaired concentration, and headache)
Changes in Blood samples analysed for markers related to low grade inflammation Baseline, 6 Weeks and 12 Weeks Including ENA-78, GCSF, GM-CSF, GRO, GRO-alpha, I-309, IL-1alpha, IL-1beta, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 p40/p70, IL-13, IL-15, IFN-gamma, MCP-1, MCP-2, MCP-3, MCSF, MDC, MIG, MIP-1delta, RANTES, SCF, SDF-1, TARC, TGF-beta1, TNF-alpha, TNF-beta, EGF, IGF-I, Angiogenin, Oncostatin M, Thrombopoietin, VEGF-A, PDGF BB, Leptin in (arbitrary units).
Changes in creatinine kinase Baseline Creatinine kinase levels (units per liter)
Changes in D-dimer Baseline D-dimer (ng/mL)
Changes in cognitive status Baseline, 6 Weeks and 12 Weeks Montreal Cognitive Assessment (MOCA) will be used as an indicator of cognitive status. Scores range between 0 and 30. A score of 26 or over is considered to be normal
Changes in visual attention and task switching Baseline, 6 Weeks and 12 Weeks The Trail Making Test will be used as an indicator of visual scanning, graphomotor speed, and executive function. This test consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy
Changes in life satisfaction Baseline, 6 Weeks and 12 Weeks A Life Satisfaction item, consisting of three questions, will be used (scored 0-10). Higher scores indicate "the best possible life overall". In addition, 2-follow-up questions asking individuals to rate their physical and mental/emotional health on a five point scale from poor to excellent. Higher scores overall indicate more satisfaction with life.
Changes in pulse wave velocity Baseline, 6 Weeks and 12 Weeks Measuring pulse wave velocity (m/seg) by VaSera VS 2000 (Fukuda Denshi, Japan)
Changes in fat mass measured with DXA Baseline, 6 Weeks and 12 Weeks Measuring in fat mass (%)
Changes in lean mass measured with DXA Baseline, 6 Weeks and 12 Weeks Measuring in lean mass (kg)
Changes in Fat max oxidation rate Baseline, 6 Weeks and 12 Weeks Measured with an incremental VO2 protocol on exercise bike by COSMED k-5 plus OMNIA (COSMED®, Rome, Italy)
Changes in Dynamic and isometric strength Baseline, 6 Weeks and 12 Weeks Muscular fitness testing (legs, chest, arms, hip and grip)
Changes in thyroid function parameters Baseline T3 and T4 levels (μg/dL)
Changes in Quality of life Baseline, 6 Weeks and 12 Weeks Two summary scores are reported from the EuroQOL EQ-5D instrument
Changes in psychological distress Baseline, 6 Weeks and 12 Weeks The 10 Item Kessler Psychological Distress Scale will be used. Scores range from 10-50, with higher scores indicating more symptoms or more frequent experience of those symptoms.
Changes in resilience Baseline, 6 Weeks and 12 Weeks The Brief Resilience Scale will be used (scores from 1-5). Higher scores indicate the individual perceives they have a better ability to 'bounce back' and recover from stressful events and/or situations.
Change in pain score using numeric 0-10 rating scale Baseline, 6 Weeks and 12 Weeks The numeric rating scale is 0-10 where 0 is no pain, 5 is moderate pain and 10 is the worst pain
Changes in physical activity levels Baseline, 6 Weeks and 12 Weeks Metabolic Equivalents (METs) throughout a week, including activity for work, during transport and leisure time, using the self-reported general physical activity questionnaire (GPAQ).
Tracking the amount of exercise variety participants feel they engage in Baseline, 6 Weeks and 12 Weeks Using the Perceived Variety in Exercise questionnaire. There are 5 items asking about exercise variety, scored 1 (false) to 6 (true), with a possible score of 5-30; higher scores indicate greater perceived variety.
Including Changes in mononuclear cells of peripheral blood (sub-sample 40 participants) Baseline, 6 Weeks and 12 Weeks CD4, CD8, PD1, CD62L, LKRG1, CD28, CD57, CD163, CD119, CD56, CD116, CD66b, CD11b, and CD14 by flow cytometry
Trial Locations
- Locations (1)
Robinson Ramírez-Vélez, Ph.D
🇪🇸Pamplona, Spain