- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04797871
Resistance Training and Clinical Status in Patients With Post Discharge Symptoms After Covid-19 (EXER-COVID)
Resistance Training Intervention on the Clinical Status in Patients With Post Discharge Symptoms After Covid-19: The "EXER-COVID Study"
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pamplona, Spain, 31001
- Robinson Ramírez-Vélez, Ph.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
Resistance training
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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.
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Active Comparator: Standard care
Non-supervised ACSM exercise guidelines
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Cardiorespiratory fitness
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Measured with an incremental VO2 protocol on exercise bike by COSMED Quark CPET plus OMNIA (COSMED®, Rome, Italy)
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Baseline, 6 Weeks and 12 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Post-COVID manifestations
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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)
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Baseline, 6 Weeks and 12 Weeks
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Changes in Blood samples analysed for markers related to low grade inflammation
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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).
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Baseline, 6 Weeks and 12 Weeks
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Changes in pulse wave velocity
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Measuring pulse wave velocity (m/seg) by VaSera VS 2000 (Fukuda Denshi, Japan)
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Baseline, 6 Weeks and 12 Weeks
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Changes in cardio-ankle vascular index (CAVI)
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Measuring Cardio-Ankle Vascular Index (%) by VaSera VS 2000 (Fukuda Denshi, Japan)
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Baseline, 6 Weeks and 12 Weeks
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Changes in Energy expenditure
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Measuring by COSMED Q-NRG+ plus OMNIA (COSMED®, Rome, Italy)
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Baseline, 6 Weeks and 12 Weeks
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Changes in bone mineral density measured with DXA
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Measuring in bone mineral density (g)
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Baseline, 6 Weeks and 12 Weeks
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Changes in fat mass measured with DXA
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Measuring in fat mass (%)
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Baseline, 6 Weeks and 12 Weeks
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Changes in lean mass measured with DXA
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Measuring in lean mass (kg)
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Baseline, 6 Weeks and 12 Weeks
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Changes in Fat max oxidation rate
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Measured with an incremental VO2 protocol on exercise bike by COSMED k-5 plus OMNIA (COSMED®, Rome, Italy)
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Baseline, 6 Weeks and 12 Weeks
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Changes in Dynamic and isometric strength
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Muscular fitness testing (legs, chest, arms, hip and grip)
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Baseline, 6 Weeks and 12 Weeks
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Changes in Axial accelerometer-based physical activity monitors
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK)
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Baseline, 6 Weeks and 12 Weeks
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Changes in blood samples analysed for markers related to oxidative stress
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Including catalase, glutathione peroxidase, peroxidase, glutathione reductase in arbitrary units.
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Baseline, 6 Weeks and 12 Weeks
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Changes in serum metabolic profiles
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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.
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Baseline, 6 Weeks and 12 Weeks
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Changes in creatinine kinase
Time Frame: Baseline
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Creatinine kinase levels (units per liter)
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Baseline
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Changes in total troponins levels (ng/mL)
Time Frame: Baseline
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Total troponins levels (ng/mL)
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Baseline
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Changes in D-dimer
Time Frame: Baseline
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D-dimer (ng/mL)
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Baseline
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Changes in thyroid function parameters
Time Frame: Baseline
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T3 and T4 levels (μg/dL)
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Baseline
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Changes in liver function
Time Frame: Baseline
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ALT in (U/L), AST and GGT in (U/L)
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Baseline
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Changes in renal function
Time Frame: Baseline
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Urea (mmol/L), sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), calcium (mmol/L), inorganic phosphorus (mmol/L) and uric acid (mmol/L)
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Baseline
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Changes in haematology parameters
Time Frame: Baseline
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White Blood Cells and Red Blood Cells (cell characterization)
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Baseline
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Changes in cognitive status
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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
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Baseline, 6 Weeks and 12 Weeks
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Changes in visual attention and task switching
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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
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Baseline, 6 Weeks and 12 Weeks
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Changes in Quality of life
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Two summary scores are reported from the EuroQOL EQ-5D instrument
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Baseline, 6 Weeks and 12 Weeks
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Changes in psychological stress
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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.
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Baseline, 6 Weeks and 12 Weeks
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Changes in physical health symptomology
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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.
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Baseline, 6 Weeks and 12 Weeks
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Changes in psychological distress
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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.
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Baseline, 6 Weeks and 12 Weeks
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Changes in depressive symptomology
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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.
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Baseline, 6 Weeks and 12 Weeks
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Changes in life satisfaction
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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.
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Baseline, 6 Weeks and 12 Weeks
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Changes in resilience
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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.
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Baseline, 6 Weeks and 12 Weeks
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Change in pain score using numeric 0-10 rating scale
Time Frame: Baseline, 6 Weeks and 12 Weeks
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The numeric rating scale is 0-10 where 0 is no pain, 5 is moderate pain and 10 is the worst pain
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Baseline, 6 Weeks and 12 Weeks
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Tracking the amount of exercise variety participants feel they engage in
Time Frame: Baseline, 6 Weeks and 12 Weeks
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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.
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Baseline, 6 Weeks and 12 Weeks
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Changes in physical activity levels
Time Frame: Baseline, 6 Weeks and 12 Weeks
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Metabolic Equivalents (METs) throughout a week, including activity for work, during transport and leisure time, using the self-reported general physical activity questionnaire (GPAQ).
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Baseline, 6 Weeks and 12 Weeks
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Including Changes in mononuclear cells of peripheral blood (sub-sample 40 participants)
Time Frame: Baseline, 6 Weeks and 12 Weeks
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CD4, CD8, PD1, CD62L, LKRG1, CD28, CD57, CD163, CD119, CD56, CD116, CD66b, CD11b, and CD14 by flow cytometry
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Baseline, 6 Weeks and 12 Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mikel Izquierdo, Ph.D, Universidad Pública de Navarra
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Central Nervous System Diseases
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Encephalomyelitis
- COVID-19
- Chronic Pain
- Stress, Psychological
- Fatigue Syndrome, Chronic
Other Study ID Numbers
- PI_2020/140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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