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

NCT ID: NCT04718506

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2022-05-27

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.

Conditions

Covid19; Post-COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise

Supervised exercise training

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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

Non-supervised inspiratory muscle training protocol

Group Type: EXPERIMENTAL

Controls

Intervention Type: BEHAVIORAL

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

Controls

Non-supervised WHO exercise guidelines

Group Type: ACTIVE_COMPARATOR

Inspiratory muscle training

Intervention Type: 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

Interventions

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. 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

Intervention Type: BEHAVIORAL

Inspiratory muscle training

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

Intervention Type: BEHAVIORAL

Controls

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Javier Courel Ibáñez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Javier Courel-Ibáñez, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Sport Sciences, University of Murcia, Spain.

Amaya Jimeno-Almazán, Dr,

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Santa Lucía, Infectious Diseases Section,

Jesús García Pallarés, Ph.D

Role: STUDY_DIRECTOR

Faculty of Sport Sciences, University of Murcia, Spain.

Locations

Faculty of Sport Sciences

Murcia, San Javier, Spain

Countries

Spain

Other Identifiers

3036/2020

Identifier Type: -

Identifier Source: org_study_id