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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Respiratory Muscle Training in Individuals With Long-term Post-COVID-19 Symptoms

NCT05597774

Covid19 Post-acute COVID-19 Syndrome

COMPLETED NA

Effects of IMT on Functional Capacity in Patients With Chronic COVID After Hospital Discharge

NCT05279430

COVID-19 Pneumonia

COMPLETED NA

Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease

NCT04734561

Covid19 Respiratory Muscle Training Respiratory Function Test +2 more

COMPLETED NA

Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

NCT05307562

COVID-19 Respiratory Infection Rehabilitation Physical Therapists

ACTIVE_NOT_RECRUITING NA

Inspiratory Muscle Training in Post COVID-19 Infection Subjects

NCT05282199

COVID-19

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

100 patients will be recruited and undergo baseline testing, including examination, immune systems, biochemistry markers, ECG, DXA, metabolic/respiratory function, VO2max, muscular fitness, lipidomic/inflammatory/oxidative markers and psychological outcomes.

After baseline testing, participants will be randomly allocated into one group receiving standard of care (control group) or a group performing personalized resistance training intervention two times a week over a period of 6 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by an independent person. Following the 8-week intervention period (with a 1-week washout period), both groups will complete a series of follow-up tests (as baseline testing). A 12-week follow-up experimental day is also planned in order to evaluate physio/psychological changes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Single (Investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise

Resistance training

Group Type EXPERIMENTAL

Resistance training

Intervention Type 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.

Standard care

Non-supervised ACSM exercise guidelines

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resistance training

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.

Intervention Type BEHAVIORAL

Standard care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No