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Rehabilitation for Post-COVID-19 Syndrome Through a Supervised Exercise Intervention (RECOVE)

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ClinicalTrials.gov Identifier: NCT04718506
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Javier Courel Ibáñez, Universidad de Murcia

Brief Summary:
This is a randomized controlled trial of the efficacy of a tailored, multicomponent exercise training with post-COVID-19 syndrome (i.e. patients who present symptoms >12 weeks once the acute phase of the disease is over). The primary objective of the study is to evaluate the clinical efficacy and safety of a tailored exercise-based treatment relative to the control arm in improving the subject clinical status in ambulatory patients.

Condition or disease Intervention/treatment Phase
Covid19 Post-COVID-19 Syndrome Behavioral: Exercise Behavioral: Controls Not Applicable

Detailed Description:

A fraction ~10% of the COVID-19 patients who undergo a variable acute symptomatic phase of the disease are coming forward with continuing effects of the disease over a month, with chronic complaints like mental fog, delayed latent periods in recalling events of recent past, tachycardia, extreme fatigue, inability to perform daily physical tasks and likely to develop stress, depression, irritability, insomnia, fear, confusion, anger and frustration. This condition is defined as post-COVID-19 syndrome and increasingly affecting a high number of people as the pandemic evolves.

The post-COVID-19 syndrome has become a usual situation in the evolutionary course of the disease with its own entity. The National Health Service (NHS) of UK has recently published a clinical guide for long-term management of the effects of COVID-19 with a comprehensive plan for the assessment and care of patients who present or develop symptoms from the fourth week after diagnosis.

The effective long-term management of the effects of COVID-19 is a challenge that requires awareness. The RECOVE project aims at determining the role of exercise in the treatment of post-COVID-19 syndrome ambulatory patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rehabilitation for Post-COVID-19 Syndrome Through a Multicomponent, Educational and Supervised Exercise Intervention [RECOVE]
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : June 12, 2021
Estimated Study Completion Date : December 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
Supervised exercise training
Behavioral: Exercise
Participants from the experimental group will complete 8 weeks of a tailored, educational and supervised multicomponent exercise program adapted from the ACSM guidelines for Chronic Obstructive Pulmonary Disease and Cardiovascular Disease. Concurrent training (i.e., develop both aerobic capacity and strength within the same training session) will be adopted since its greater adherence and proven adaptations in 6 weeks. Participants will complete a 3-days-a-week training routine: two days of resistance training (RT, 50-75% 1RM (one-repetition maximum), 2-4 sets, 6-12 repetitions, 5 exercises) combined with Moderate Intensity Variable Training (MIVT: 4-6 x 3-5 min at 65-80% Heart Rate Reserve (HRR) / 2-3 min at 50-70% HRR), and one day of Light Intensity Continuous Training (LICT: 30-60 min, 65-70% HRR). Progressions will be individualized and consistent with patient tolerance. Sessions will be supervised by certified strength and conditioning coaches, Graduated in Sports Sciences

Active Comparator: Controls
Non-supervised SEPAR exercise guidelines
Behavioral: Controls
Controls will follow the general physical activity and return to sport guidelines provided by the SEPAR




Primary Outcome Measures :
  1. Changes in subject clinical status [ Time Frame: Baseline to 8 Weeks ]
    Post-COVID Functional Status (PCFS) on a 5-point ordinal scale (0 to 4 grades) and medical screening


Secondary Outcome Measures :
  1. Changes in cardiovascular fitness: Maximal oxygen consumption (VO2max) [ Time Frame: Baseline to 8 Weeks ]
    VO2max estimated from standard algorithms using a submaximal multistage and individualized cardiopulmonary exercise test on cycloergometer. Heart rate (HR), rate of perceive effort (RPE) and load (W) will be combined to report VO2max in mml/kg/min.

  2. Changes in neuromuscular performance during resistance exercise: Barbell Mean Propulsive Velocity (MPV) [ Time Frame: Baseline to 8 Weeks ]
    Barbell displacement and velocity will be monitored in real time using a linear transductor during a progressive resistance training exercise tests. Displacement and velocity will be combined to report MPV

  3. Changes in balance: center of pressure (COP) sway [ Time Frame: Baseline to 8 Weeks ]
    COP sway during a balance test will be measured using a high resolution force plate

  4. Changes in pulmonary function: Forced Vital Capacity (FVC) [ Time Frame: Baseline to 8 Weeks ]
    The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry.

  5. Changes in pulmonary function: Forced expiratory volume (FEV) [ Time Frame: Baseline to 8 Weeks ]
    The amount of air exhaled (mL) during the first (FEV1), second (FEV2), and third seconds (FEV3) of the forced breath will be measured by spirometry.

  6. Changes in high sensitivity C-reactive protein (hsCPR) [ Time Frame: Baseline to 8 Weeks ]
    hsCPR (mg/L) determined by blood-based biochemistry analysis

  7. Changes in D-dimer [ Time Frame: Baseline to 8 Weeks ]
    D-dimer (mg/L) determined by blood-based biochemistry analysis

  8. Changes in Troponin [ Time Frame: Baseline to 8 Weeks ]
    Troponin (ng/mL) determined by blood-based biochemistry analysis

  9. Changes in glutamic-pyruvic transaminase (GPT) [ Time Frame: Baseline to 8 Weeks ]
    GPT(IU/L) determined by blood-based biochemistry analysis

  10. Changes in serum creatine kinase (CK) [ Time Frame: Baseline to 8 Weeks ]
    CK (U/L) determined by blood-based biochemistry analysis lactate dehydrogenase (LDH)

  11. Changes in lactate dehydrogenase (LDH) [ Time Frame: Baseline to 8 Weeks ]
    LDH (U/L) determined by blood-based biochemistry analysis

  12. Changes in physical activity levels [ Time Frame: Baseline to 8 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)

  13. Changes in tolerance to exercise: DePaul Symptom Questionnaire for Post-exertional malaise (DSQ-PEM) scores [ Time Frame: Baseline to 8 Weeks ]
    DSQ-PEM will be administrate to obtain a score of tolerance to exercise (DSQ-PEM Scoring depends on the 10-item mixed questionnaire including scale and yes/no questions)

  14. Changes in fatigue: Chalder Fatigue Scale scale (CFQ-11) [ Time Frame: Baseline to 8 Weeks ]
    CFQ-11 will be administrate to obtain a score of fatigue (Each of the 11 items are answered on a 4-point scale ranging from the asymptomatic to maximum symptomology)

  15. Changes in anxiety: Generalized Anxiety Disorder scale (GAD7) [ Time Frame: Baseline to 8 Weeks ]
    GAD7 will be administrate to obtain a score of anxiety status (total score for the seven items ranges from 0 to 21)

  16. Changes in depression: Patient Health Questionnaire (PHQ9) [ Time Frame: Baseline to 8 Weeks ]
    PHQ9 will be administrate to obtain a score of depression status (total score for the nine items ranges from 0 to 27)

  17. Changes in health related quality of life: 12-item Short Form Survey (SF12) [ Time Frame: Baseline to 8 Weeks ]
    Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores will be reported as Z-scores (difference compared to the population average, measured in standard deviations).


Other Outcome Measures:
  1. Changes in Percent Body Fat [ Time Frame: Baseline to 8 Weeks ]
    Body composition will be measured by bioelectrical impedance analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Non-coincident participation in any intervention trial
  • Capable and willing to provide an informed consent

Exclusion Criteria:

  • Refusal to participate expressed by patient or legally authorized representative if they are present
  • Pregnancy or breast-feeding.
  • Acute heart attack (recent 3-6 months) or unstable angina
  • Uncontrolled atrial or ventricular arrhythmias
  • Aortic dissecting aneurysm
  • Severe aortic stenosis
  • Acute endocarditis / pericarditis
  • Uncontrolled high blood pressure (>180/100 mmHg)
  • Acute thromboembolism
  • Acute or severe heart failure
  • Acute or severe respiratory failure
  • Uncontrolled acute decompensated diabetes mellitus or low blood sugar
  • A recent fracture in the last month.
  • Conditions preventing cooperation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718506


Contacts
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Contact: Javier Courel-Ibáñez, Ph.D 868-88-88-11 courel@um.es

Locations
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Spain
Faculty of Sport Sciences Recruiting
Murcia, San Javier, Spain, 30720
Contact: Javier Courel-Ibáñez, Ph.D    +34 868 88 88 11    courel@um.es   
Sponsors and Collaborators
Universidad de Murcia
Investigators
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Principal Investigator: Javier Courel-Ibáñez, Ph.D Faculty of Sport Sciences, University of Murcia, Spain.
Principal Investigator: Amaya Jimeno-Almazán, Dr, University Hospital of Santa Lucía, Infectious Diseases Section,
Study Director: Jesús García Pallarés, Ph.D Faculty of Sport Sciences, University of Murcia, Spain.
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Responsible Party: Javier Courel Ibáñez, Principal Investigator, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT04718506    
Other Study ID Numbers: 3036/2020
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes