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Covid19EXER-COVIDNCT04797871

Resistance Training and Clinical Status in Patients With Post Discharge Symptoms After Covid-19

A study testing Resistance training in people with Covid19 and SARS-CoV2, run by Universidad Pública de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Covid19, SARS-CoV2, Fatigue Syndrome, Chronic
What is being tested?
Resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
8 Mar 2021to 18 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Robinson Ramírez-Vélez, Ph.D

    Pamplona, 31001

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Resistance training, Standard care
Medical subject headings
COVID-19, Fatigue Syndrome, Chronic, Stress, Psychological, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance trainingBehavioural

    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.

  • Standard careBehavioural

    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.

Study groups in NCT04797871
Study groupRoleWhat they receive
ExerciseExperimentalResistance training
Receives: Behavioral: Resistance training
Standard careActive comparatorNon-supervised ACSM exercise guidelines
Receives: Behavioral: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Cardiorespiratory fitness

    Measured with an incremental VO2 protocol on exercise bike by COSMED Quark CPET plus OMNIA (COSMED®, Rome, Italy)

    Measured: Baseline, 6 Weeks and 12 Weeks

Secondary outcomes (33)
  1. 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)

    Measured: Baseline, 6 Weeks and 12 Weeks

  2. 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).

    Measured: Baseline, 6 Weeks and 12 Weeks

  3. Changes in pulse wave velocity

    Measuring pulse wave velocity (m/seg) by VaSera VS 2000 (Fukuda Denshi, Japan)

    Measured: Baseline, 6 Weeks and 12 Weeks

  4. Changes in cardio-ankle vascular index (CAVI)

    Measuring Cardio-Ankle Vascular Index (%) by VaSera VS 2000 (Fukuda Denshi, Japan)

    Measured: Baseline, 6 Weeks and 12 Weeks

  5. Changes in Energy expenditure

    Measuring by COSMED Q-NRG+ plus OMNIA (COSMED®, Rome, Italy)

    Measured: Baseline, 6 Weeks and 12 Weeks

  6. Changes in bone mineral density measured with DXA

    Measuring in bone mineral density (g)

    Measured: Baseline, 6 Weeks and 12 Weeks

  7. Changes in fat mass measured with DXA

    Measuring in fat mass (%)

    Measured: Baseline, 6 Weeks and 12 Weeks

  8. Changes in lean mass measured with DXA

    Measuring in lean mass (kg)

    Measured: Baseline, 6 Weeks and 12 Weeks

  9. Changes in Fat max oxidation rate

    Measured with an incremental VO2 protocol on exercise bike by COSMED k-5 plus OMNIA (COSMED®, Rome, Italy)

    Measured: Baseline, 6 Weeks and 12 Weeks

  10. Changes in Dynamic and isometric strength

    Muscular fitness testing (legs, chest, arms, hip and grip)

    Measured: Baseline, 6 Weeks and 12 Weeks

  11. 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)

    Measured: Baseline, 6 Weeks and 12 Weeks

  12. Changes in blood samples analysed for markers related to oxidative stress

    Including catalase, glutathione peroxidase, peroxidase, glutathione reductase in arbitrary units.

    Measured: Baseline, 6 Weeks and 12 Weeks

  13. 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.

    Measured: Baseline, 6 Weeks and 12 Weeks

  14. Changes in creatinine kinase

    Creatinine kinase levels (units per liter)

    Measured: Baseline

  15. Changes in total troponins levels (ng/mL)

    Total troponins levels (ng/mL)

    Measured: Baseline

  16. Changes in D-dimer

    D-dimer (ng/mL)

    Measured: Baseline

  17. Changes in thyroid function parameters

    T3 and T4 levels (μg/dL)

    Measured: Baseline

  18. Changes in liver function

    ALT in (U/L), AST and GGT in (U/L)

    Measured: Baseline

  19. 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)

    Measured: Baseline

  20. Changes in haematology parameters

    White Blood Cells and Red Blood Cells (cell characterization)

    Measured: Baseline

  21. 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

    Measured: Baseline, 6 Weeks and 12 Weeks

  22. 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

    Measured: Baseline, 6 Weeks and 12 Weeks

  23. Changes in Quality of life

    Two summary scores are reported from the EuroQOL EQ-5D instrument

    Measured: Baseline, 6 Weeks and 12 Weeks

  24. 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.

    Measured: Baseline, 6 Weeks and 12 Weeks

  25. 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.

    Measured: Baseline, 6 Weeks and 12 Weeks

  26. 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.

    Measured: Baseline, 6 Weeks and 12 Weeks

  27. 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.

    Measured: Baseline, 6 Weeks and 12 Weeks

  28. 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.

    Measured: Baseline, 6 Weeks and 12 Weeks

  29. 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.

    Measured: Baseline, 6 Weeks and 12 Weeks

  30. 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

    Measured: Baseline, 6 Weeks and 12 Weeks

  31. 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.

    Measured: Baseline, 6 Weeks and 12 Weeks

  32. 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).

    Measured: Baseline, 6 Weeks and 12 Weeks

  33. 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

    Measured: Baseline, 6 Weeks and 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start8 Mar 2021
  3. Primary completion18 Sep 2022
  4. Study completion18 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04797871
Sponsor's protocol ID
PI_2020/140
Acronym
EXER-COVID
Status last verified
Jul 2022
First submitted
8 Mar 2021
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garcia-Alonso N, Izquierdo M, Arasanz H, Ramirez-Velez R. Immunological effects of supervised exercise in long COVID in adults: A secondary analysis of a randomized crossover trial. Physiol Rep. 2026 Sep;14(17):e71031. doi: 10.14814/phy2.71031.

    PubMed 42665974
  • 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.

    PubMed 35945634

Questions about this trial

What is this clinical trial studying?

A study testing Resistance training in people with Covid19 and SARS-CoV2, run by Universidad Pública de Navarra at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Cardiorespiratory fitness (time frame: Baseline, 6 Weeks and 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04797871, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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