EVALUATION AND IMPLEMENTATION OF A MULTIMODAL INTERVENTION TO REDUCE SYMPTOMS OF LONG COVID/PROLONGED COVID IN THE ADULT POPULATION OF PUNTA ARENAS, CHILE.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Long COVID-19 Syndrome
- Sponsor
- Universidad de Magallanes
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related adverse events assessed by Cardiorespiratory Capacity
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Due to the COVID-19 pandemic, the world has seen the need to identify groups of patients who experience various effects in the medium and long term after recovering from the initial illness. These medium- and long-term effects are collectively known as the post-COVID-19 condition, Long-COVID, or prolonged COVID. Current evidence indicates, with conservative estimates, that between 10% and 20% of the population could be affected. Its nature is varied and ranges from physical conditions such as chronic fatigue, dyspnea and muscle weakness, to neurocognitive (compromised memory, decreased concentration) and psychological (anxiety, depression, anguish, stress). Early recognition and treatment of this symptom burden is essential for physical recovery and mental health. Due to its multivariate nature, it has been suggested that optimal recovery of patients' quality of life would only be achieved to the extent that their main symptoms are addressed from an interdisciplinary perspective.
Investigators
Lidia M. Amarales Osorio
Principal Investigator
Universidad de Magallanes
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria will be: Adults between 40 and 80 years of age. Individuals will be included if they have had a positive polymerase chain reaction (PCR) test diagnosis of SARS-CoV-2 virus, presence of dyspnea and/or fatigue greater than 3 months after COVID-19 diagnosis, at least 1 point higher on the modified Medical Research Council Scale (mMRC) compared to the period before infection. All participants must have no contraindications to perform the exercise and training tests and must be able to read, understand and sign the information and consent form.
Exclusion Criteria
- •Individuals with one of the exclusion criteria will not be eligible for our research project these are: pulmonary embolism; absolute and relative contraindication to cardiopulmonary stress testing or physical training; severe exercise intolerance, significant cardiac arrhythmias or ischemia during low intensity exercise, severe pulmonary hypertension; severe pulmonary disease (e.g.: chronic obstructive pulmonary disease, severe COVID-19 related symptoms, severe asthma); recent cardiovascular event (cardiac decompensation, angioplasty or cardiac surgery less than 4 weeks old, valvular heart disease requiring surgical correction, pericarditis, ventricular rhythm disturbances and unstable despite treatment); renal failure requiring dialysis; Heart failure (NYHA III or IV).
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events assessed by Cardiorespiratory Capacity
Time Frame: 24 months
The primary outcome of the study will be measured by a maximal cardiopulmonary exercise test (CPET) on a cycloergometer. The protocol will be individualised and will include a 3-minute warm-up at 20 Watts, followed by an increasing workload of 10-20 W/min (depending on the participant's fitness level) until exhaustion, maintaining a cadence greater than 60 rpm. Electrocardiogram and oxygen saturation will be continuously monitored, while rating of perceived exertion and blood pressure will be measured every two minutes during the test. Continuously measured at rest, as well as during exercise and recovery: minute ventilation, oxygen consumption and carbon dioxide production. Gas exchange shall be collected on a breath-by-breath basis and expressed as a 15-second time average for analysis.
Secondary Outcomes
- Functional profiles(24 months)
- Quality of life indicators(24 months)
- Cardiorespiratory profiles(24 months)
- Psychological profiles(24 months)
- Neurocognitive profiles(24 months)
- Nutritional profile(24 months)