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

Universidad de Murcia

Status: Completed

Conditions: Post-COVID-19 Syndrome; Covid19

Treatments: Behavioral: Inspiratory muscle training; Behavioral: Controls; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04718506

3036/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 3 patient groups

Exercise

Experimental group

Description:

Supervised exercise training

Treatment:

Behavioral: Exercise

Inspiratory muscle training

Experimental group

Description:

Non-supervised inspiratory muscle training protocol

Treatment:

Behavioral: Controls

Controls

Active Comparator group

Description:

Non-supervised WHO exercise guidelines

Treatment:

Behavioral: Inspiratory muscle training