Resistance Training and Clinical Status in Patients With Post Discharge Symptoms After Covid-19

NCT04797871 | Completed

• 1 other identifier: PI_2020/140
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 survivors commonly exhibit a marked extra-respiratory complication affecting the cardiac (arrhythmias and myocardial injury), renal (acute kidney injury), gastrointestinal, nervous (neuropathy, encephalopathy), endocrine and musculoskeletal (weakness, pain, and fatigue) systems. In this context, several studies have found that resistance training intervention promotes important health-related benefits, including cardiac function, compared to aerobic exercise training. Other exercise adaptations include increased skeletal muscle metabolism function, yet physio/psychological adaptations are known to be limited in COVID-19 survivors. Hence, given that resistance training intervention is implemented in a manner that is tolerable to the individual patient, it may be a potential beneficiary "personalized" rehabilitation treatment for patients with COVID-19 syndrome ambulatory. The "EXER-COVID Clinical Study" project aims at determining the role of personalized exercise intervention in the treatment of post-COVID-19 syndrome ambulatory patients.

Conditions

Covid19; SARS-CoV2; Fatigue Syndrome, Chronic; Stress, Psychological; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Changes in Cardiorespiratory fitness

  Measured with an incremental VO2 protocol on exercise bike by COSMED Quark CPET plus OMNIA (COSMED®, Rome, Italy)

  Baseline, 6 Weeks and 12 Weeks

Secondary Outcomes (33)

• Changes in Post-COVID manifestations

  Baseline, 6 Weeks and 12 Weeks

• Changes in Blood samples analysed for markers related to low grade inflammation

  Baseline, 6 Weeks and 12 Weeks

• Changes in pulse wave velocity

  Baseline, 6 Weeks and 12 Weeks

• Changes in cardio-ankle vascular index (CAVI)

  Baseline, 6 Weeks and 12 Weeks

• Changes in Energy expenditure

  Baseline, 6 Weeks and 12 Weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Resistance training

Behavioral: Resistance training

Standard care

ACTIVE COMPARATOR

Non-supervised ACSM exercise guidelines

Behavioral: Standard care

Interventions

Resistance training BEHAVIORAL

Participants will complete a 2-days-a-week training routine: Resistance training (RT, 50-75% 1RM (one-repetition maximum), 4 sets, 8-12 repetitions, 4 exercises). The warn up include Light Intensity Continuous Training (8-10 min, 65-70% HRR). Progressions will be individualized and consistent with patient tolerance. Sessions will be supervised by Physiotherapists and Graduated in Sports Sciences.

Exercise

Standard care BEHAVIORAL

This group will be allocated to standard care and therefore no supervised exercise regimen according to scientific guidelines for general physical activity and return to sport provided by the ACSM guidelines for Chronic Obstructive Pulmonary Disease and Cardiovascular Disease.

Standard care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years
• 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.
• Capable and willing to provide an informed consent.

You may not qualify if:

• Pregnancy or breast-feeding.
• Present atrial fibrillation.
• Diagnosed with acute myocarditis.
• Health conditions that prevent participating in the exercise intervention
• Patients who cannot undergo VO2max (e.g. acute heart attack or unstable angina, aortic stenosis, acute endocarditis / pericarditis, uncontrolled high blood pressure, acute thromboembolism, severe heart failure, respiratory failure and uncontrolled acute decompensated diabetes mellitus or low blood sugar).
• Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.

Sponsors & Collaborators

• Universidad Pública de Navarra: lead
• Fundacion Miguel Servet: collaborator
• Complejo Hospitalario de Navarra: collaborator

Study Sites (1)

Robinson Ramírez-Vélez, Ph.D

Pamplona, 31001, Spain

Location

Related Publications (1)

• Ramirez-Velez R, Oteiza J, de Tejerina JMCF, Garcia-Alonso N, Legarra-Gorgonon G, Oscoz-Ochandorena S, Arasanz H, Garcia-Alonso Y, Correa-Rodriguez M, Izquierdo M. Resistance training and clinical status in patients with postdischarge symptoms after COVID-19: protocol for a randomized controlled crossover trial "The EXER-COVID Crossover Study". Trials. 2022 Aug 9;23(1):643. doi: 10.1186/s13063-022-06608-y.

  PMID: 35945634 DERIVED

MeSH Terms

Conditions

COVID-19; Fatigue Syndrome, Chronic; Stress, Psychological; Chronic Pain

Interventions

Resistance Training; Standard of Care

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; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mikel Izquierdo, Ph.D

  Universidad Publica de Navarra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single (Investigator)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: March 8, 2021
• Primary Completion: September 18, 2022
• Study Completion: September 18, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)