Clinical trial NCT04718506: Rehabilitation for Post-COVID-19 Syndrome Through a Supervised Exercise Intervention
Official title: Rehabilitation for Post-COVID-19 Syndrome Through a Multicomponent, Educational and Supervised Exercise Intervention [RECOVE]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Post-COVID-19 Syndrome
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes in subject clinical status
timeFrame: Baseline to 8 Weeks
Secondary outcomes:
measure: Changes in cardiovascular fitness: Maximal oxygen consumption (VO2max)
timeFrame: Baseline to 8 Weeks
measure: Changes in neuromuscular performance during resistance exercise: Barbell Mean Propulsive Velocity (MPV)
timeFrame: Baseline to 8 Weeks
measure: Changes in balance: center of pressure (COP) sway
timeFrame: Baseline to 8 Weeks
measure: Changes in pulmonary function: Forced Vital Capacity (FVC)
timeFrame: Baseline to 8 Weeks
measure: Changes in pulmonary function: Forced expiratory volume (FEV)
timeFrame: Baseline to 8 Weeks
measure: Changes in high sensitivity C-reactive protein (hsCPR)
timeFrame: Baseline to 8 Weeks
measure: Changes in D-dimer
timeFrame: Baseline to 8 Weeks
measure: Changes in Troponin
timeFrame: Baseline to 8 Weeks
measure: Changes in glutamic-pyruvic transaminase (GPT)
timeFrame: Baseline to 8 Weeks
measure: Changes in serum creatine kinase (CK)
timeFrame: Baseline to 8 Weeks
measure: Changes in lactate dehydrogenase (LDH)
timeFrame: Baseline to 8 Weeks
measure: Changes in physical activity levels
timeFrame: Baseline to 8 Weeks
measure: Changes in tolerance to exercise: DePaul Symptom Questionnaire for Post-exertional malaise (DSQ-PEM) scores
timeFrame: Baseline to 8 Weeks
measure: Changes in fatigue: Chalder Fatigue Scale scale (CFQ-11)
timeFrame: Baseline to 8 Weeks
measure: Changes in anxiety: Generalized Anxiety Disorder scale (GAD7)
timeFrame: Baseline to 8 Weeks
measure: Changes in depression: Patient Health Questionnaire (PHQ9)
timeFrame: Baseline to 8 Weeks
measure: Changes in health related quality of life: 12-item Short Form Survey (SF12)
timeFrame: Baseline to 8 Weeks
Other outcomes:
measure: Changes in Percent Body Fat
timeFrame: Baseline to 8 Weeks
Locations:
city: Murcia
country: Spain
facility: Faculty of Sport Sciences
state: San Javier
Study officials:
affiliation: Faculty of Sport Sciences, University of Murcia, Spain.
name: Javier Courel-Ibáñez, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Santa Lucía, Infectious Diseases Section,
name: Amaya Jimeno-Almazán, Dr,
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Sport Sciences, University of Murcia, Spain.
name: Jesús García Pallarés, Ph.D
role: STUDY_DIRECTOR
References: