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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
100
Participants will complete a 2-days-a-week training routine: Resistance training (RT, 50-75% 1RM (one-repetition maximum), 4 sets, 8-12 repetitions, 4 exercises). The warn up include Light Intensity Continuous Training (8-10 min, 65-70% HRR). Progressions will be individualized and consistent with patient tolerance. Sessions will be supervised by Physiotherapists and Graduated in Sports Sciences.
This group will be allocated to standard care and therefore no supervised exercise regimen according to scientific guidelines for general physical activity and return to sport provided by the ACSM guidelines for Chronic Obstructive Pulmonary Disease and Cardiovascular Disease.
Robinson Ramírez-Vélez, Ph.D
Pamplona, Spain
Changes in Cardiorespiratory fitness
Measured with an incremental VO2 protocol on exercise bike by COSMED Quark CPET plus OMNIA (COSMED®, Rome, Italy)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in Post-COVID manifestations
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)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in Blood samples analysed for markers related to low grade inflammation
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).
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in pulse wave velocity
Measuring pulse wave velocity (m/seg) by VaSera VS 2000 (Fukuda Denshi, Japan)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in cardio-ankle vascular index (CAVI)
Measuring Cardio-Ankle Vascular Index (%) by VaSera VS 2000 (Fukuda Denshi, Japan)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in Energy expenditure
Measuring by COSMED Q-NRG+ plus OMNIA (COSMED®, Rome, Italy)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in bone mineral density measured with DXA
Measuring in bone mineral density (g)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in fat mass measured with DXA
Measuring in fat mass (%)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in lean mass measured with DXA
Measuring in lean mass (kg)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in Fat max oxidation rate
Measured with an incremental VO2 protocol on exercise bike by COSMED k-5 plus OMNIA (COSMED®, Rome, Italy)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in Dynamic and isometric strength
Muscular fitness testing (legs, chest, arms, hip and grip)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in Axial accelerometer-based physical activity monitors
Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK)
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in blood samples analysed for markers related to oxidative stress
Including catalase, glutathione peroxidase, peroxidase, glutathione reductase in arbitrary units.
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in serum metabolic profiles
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.
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in creatinine kinase
Creatinine kinase levels (units per liter)
Time frame: Baseline
Changes in total troponins levels (ng/mL)
Total troponins levels (ng/mL)
Time frame: Baseline
Changes in D-dimer
D-dimer (ng/mL)
Time frame: Baseline
Changes in thyroid function parameters
T3 and T4 levels (μg/dL)
Time frame: Baseline
Changes in liver function
ALT in (U/L), AST and GGT in (U/L)
Time frame: Baseline
Changes in renal function
Urea (mmol/L), sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), calcium (mmol/L), inorganic phosphorus (mmol/L) and uric acid (mmol/L)
Time frame: Baseline
Changes in haematology parameters
White Blood Cells and Red Blood Cells (cell characterization)
Time frame: Baseline
Changes in cognitive status
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
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in visual attention and task switching
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
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in Quality of life
Two summary scores are reported from the EuroQOL EQ-5D instrument
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in psychological stress
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.
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in physical health symptomology
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.
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in psychological distress
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.
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in depressive symptomology
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.
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in life satisfaction
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.
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in resilience
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.
Time frame: Baseline, 6 Weeks and 12 Weeks
Change in pain score using numeric 0-10 rating scale
The numeric rating scale is 0-10 where 0 is no pain, 5 is moderate pain and 10 is the worst pain
Time frame: Baseline, 6 Weeks and 12 Weeks
Tracking the amount of exercise variety participants feel they engage in
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.
Time frame: Baseline, 6 Weeks and 12 Weeks
Changes in physical activity levels
Metabolic Equivalents (METs) throughout a week, including activity for work, during transport and leisure time, using the self-reported general physical activity questionnaire (GPAQ).
Time frame: Baseline, 6 Weeks and 12 Weeks
Including Changes in mononuclear cells of peripheral blood (sub-sample 40 participants)
CD4, CD8, PD1, CD62L, LKRG1, CD28, CD57, CD163, CD119, CD56, CD116, CD66b, CD11b, and CD14 by flow cytometry
Time frame: Baseline, 6 Weeks and 12 Weeks
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