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

NCT04718506 | Completed

• 1 other identifier: 3036/2020
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes in subject clinical status

  Post-COVID Functional Status (PCFS) on a 5-point ordinal scale (0 to 4 grades) and medical screening

  Baseline to 8 Weeks

Secondary Outcomes (17)

• Changes in cardiovascular fitness: Maximal oxygen consumption (VO2max)

  Baseline to 8 Weeks

• Changes in neuromuscular performance during resistance exercise: Barbell Mean Propulsive Velocity (MPV)

  Baseline to 8 Weeks

• Changes in balance: center of pressure (COP) sway

  Baseline to 8 Weeks

• Changes in pulmonary function: Forced Vital Capacity (FVC)

  Baseline to 8 Weeks

• Changes in pulmonary function: Forced expiratory volume (FEV)

  Baseline to 8 Weeks

Other Outcomes (1)

• Changes in Percent Body Fat

  Baseline to 8 Weeks

Study Arms (3)

Exercise

EXPERIMENTAL

Supervised exercise training

Behavioral: Exercise

Inspiratory muscle training

EXPERIMENTAL

Non-supervised inspiratory muscle training protocol

Behavioral: Controls

Controls

ACTIVE COMPARATOR

Non-supervised WHO exercise guidelines

Behavioral: Inspiratory muscle training

Interventions

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

Exercise

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

Controls BEHAVIORAL

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

Inspiratory muscle training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Faculty of Sport Sciences

Murcia, San Javier, 30720, Spain

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Javier Courel-Ibáñez, Ph.D

  Faculty of Sport Sciences, University of Murcia, Spain.

  PRINCIPAL INVESTIGATOR

• Amaya Jimeno-Almazán, Dr,

  University Hospital of Santa Lucía, Infectious Diseases Section,

  PRINCIPAL INVESTIGATOR

• Jesús García Pallarés, Ph.D

  Faculty of Sport Sciences, University of Murcia, Spain.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 22, 2021
• Study Start: January 12, 2021
• Primary Completion: February 6, 2022
• Study Completion: May 27, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

ES (1)