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

Not Applicable

Completed

• Conditions: Post-COVID-19 Syndrome; Covid19
• Interventions: Behavioral: Exercise; Behavioral: Inspiratory muscle training; Behavioral: Controls

• Registration Number: NCT04718506
• Lead Sponsor: Universidad de Murcia

Brief Summary

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.

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.

Study Timeline

• Study Start: 2021-01-12
• Study First Submitted: 2021-01-16
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Primary Completion: 2022-02-06
• Study Completion: 2022-05-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Supervised exercise training
Controls	Inspiratory muscle training	Non-supervised WHO exercise guidelines
Inspiratory muscle training	Controls	Non-supervised inspiratory muscle training protocol

Primary Outcome Measures

Name	Time	Method
Changes in subject clinical status	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

Name	Time	Method
Changes in high sensitivity C-reactive protein (hsCPR)	Baseline to 8 Weeks	hsCPR (mg/L) determined by blood-based biochemistry analysis
Changes in serum creatine kinase (CK)	Baseline to 8 Weeks	CK (U/L) determined by blood-based biochemistry analysis lactate dehydrogenase (LDH)
Changes in tolerance to exercise: DePaul Symptom Questionnaire for Post-exertional malaise (DSQ-PEM) scores	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)
Changes in pulmonary function: Forced expiratory volume (FEV)	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.
Changes in lactate dehydrogenase (LDH)	Baseline to 8 Weeks	LDH (U/L) determined by blood-based biochemistry analysis
Changes in anxiety: Generalized Anxiety Disorder scale (GAD7)	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)
Changes in neuromuscular performance during resistance exercise: Barbell Mean Propulsive Velocity (MPV)	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
Changes in D-dimer	Baseline to 8 Weeks	D-dimer (mg/L) determined by blood-based biochemistry analysis
Changes in depression: Patient Health Questionnaire (PHQ9)	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)
Changes in balance: center of pressure (COP) sway	Baseline to 8 Weeks	COP sway during a balance test will be measured using a high resolution force plate
Changes in health related quality of life: 12-item Short Form Survey (SF12)	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).
Changes in cardiovascular fitness: Maximal oxygen consumption (VO2max)	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.
Changes in pulmonary function: Forced Vital Capacity (FVC)	Baseline to 8 Weeks	The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry.
Changes in Troponin	Baseline to 8 Weeks	Troponin (ng/mL) determined by blood-based biochemistry analysis
Changes in glutamic-pyruvic transaminase (GPT)	Baseline to 8 Weeks	GPT(IU/L) determined by blood-based biochemistry analysis
Changes in physical activity levels	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)
Changes in fatigue: Chalder Fatigue Scale scale (CFQ-11)	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)

Trial Locations

Locations (1)

Faculty of Sport Sciences; 🇪🇸 Murcia, San Javier, Spain