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Completed

NCT Number: NCT04718506

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

This is a randomized controlled trial of the efficacy of a tailored exercise program, based on multicomponent exercise training and/or inspiratory muscle training, compared to the WHO self-management leaflet commonly used in outpatient scenarios, on the recovery of persistent symptoms and functional limitations after COVID-19.

. 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.

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Key information

Conditions

Covid19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sport Sciences

Murcia, San Javier, 30720, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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. Participants will complete a 3-days-a-week concurrent training routine: two days of resistance training (50% 1RM (one-repetition maximum), 3 sets, 8 repetitions, 4 exercises [squat, bench press, deadlift and bench pull]) combined with Moderate Intensity Variable Training (MIVT: 4-6 x 3-5 min at 70-80% Heart Rate Reserve (HRR) / 2-3 min at 55-65% 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

Inspiratory Muscle Training

Behavioral

Participants enrolled in the inspiratory muscle training protocol will used the PowerBreath® Classic Heath Series mechanic threshold devices to perform 1 set of 30 repetitions, twice a day, every day of the week. This assumes a work intensity of approximately 62.5% ± 4.6% of the PIM (maximum inspiratory pressure). Increase in resistance will be made every two weeks by turning the load adjustment clockwise ¼ to 1 full turn, pending on participant tolerance to maintain a 12-15 RPE on modified Borg scale. The training will be preceded by a warm-up at 80% of the 30 RM load, with 2 min of rest between sets

Controls

Behavioral

Controls will be advised (non-supervised) to follow the WHO guidelines: Support for Rehabilitation: Self-Management after COVID-19 Related Illness

Primary outcomes

  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 outcomes

  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 outcomes

  1. Changes in Percent Body Fat

    Time frame: Baseline to 8 Weeks

    Body composition will be measured by bioelectrical impedance analysis

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Rehabilitation for Post-COVID-19 Syndrome Through a Multicomponent, Educational and Supervised Exercise Intervention [RECOVE]

Acronym: RECOVE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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