Multimodal Long Covid19

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2024-11-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Long COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention model based on a clinical trial, in which the effectiveness of multimodal treatment will be evaluated in a research group through an ex ante, ex post measurement and then another follow-up measurement compared to a control group. In the first stage, focused on diagnosis, physical, neurological and mental health evaluations will be carried out, to then begin an interdisciplinary treatment process for 6 months, the second stage will be a retest evaluation using the same parameters used at the beginning, applied at the end of the intervention, and finally in the third stage, to evaluate the results with respect to a follow-up carried out 3 months after the end of the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

Multimodal rehabilitation: physical, psychological and cognitive training and treatment program at the Teaching and Research Assistance Center of the University of Magellanus.

Group Type ACTIVE_COMPARATOR

Multimodal intervention in Long Covid19

Intervention Type OTHER

The intervention will consist of physical, psychological, cognitive and nutritional training and treatment to be carried out at the Teaching and Research Assistance Center of the University of Magellanus (CADI UMAG), program includes 12 sessions of cognitive behavioral therapy sessions, 12 kinesic rehabilitation sessions, 12 treatment sessions per nutrition professional, 12 rehabilitation sessions with occupational therapy professional and 12 rehabilitation sessions with a speech therapist.

Control group

Individuals who must maintain their daily habits and/or usual care at their health center.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multimodal intervention in Long Covid19

The intervention will consist of physical, psychological, cognitive and nutritional training and treatment to be carried out at the Teaching and Research Assistance Center of the University of Magellanus (CADI UMAG), program includes 12 sessions of cognitive behavioral therapy sessions, 12 kinesic rehabilitation sessions, 12 treatment sessions per nutrition professional, 12 rehabilitation sessions with occupational therapy professional and 12 rehabilitation sessions with a speech therapist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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).

Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No