Multimodal Long Covid19

NCT05932797 | Unknown DMC

• 1 other identifier: SA22I0135
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID-19 Syndrome

Keywords

Multimodal; Covid19

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events assessed by Cardiorespiratory Capacity

  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.

  24 months

Secondary Outcomes (9)

• Cardiorespiratory profiles

  24 months

• Cardiorespiratory profiles

  24 months

• Cardiorespiratory profiles

  24 months

• Psychological profiles

  24 months

• Psychological profiles

  24 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Other: Multimodal intervention in Long Covid19

Control group

NO INTERVENTION

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

Interventions

Multimodal intervention in Long Covid19 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.

Intervention group

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidad de Magallanes: lead
• Teaching Assistance and Research Center of the University of Magallanes CADI-UMAG: collaborator
• Clinical Hospital Dr. Lautaro Navarro Avaria: collaborator

Study Sites (1)

Universidad de Magallanes

Punta Arenas, Provincia De Magallanes, 6200000, Chile

Location

Related Publications (3)

• Sarmiento Varon L, Gonzalez-Puelma J, Medina-Ortiz D, Aldridge J, Alvarez-Saravia D, Uribe-Paredes R, Navarrete MA. The role of machine learning in health policies during the COVID-19 pandemic and in long COVID management. Front Public Health. 2023 Apr 11;11:1140353. doi: 10.3389/fpubh.2023.1140353. eCollection 2023.

  PMID: 37113165 BACKGROUND

• Alvarado-Aravena C, Arriaza K, Castillo-Aguilar M, Flores K, Dagnino-Subiabre A, Estrada-Goic C, Nunez-Espinosa C. Effect of Confinement on Anxiety Symptoms and Sleep Quality during the COVID-19 Pandemic. Behav Sci (Basel). 2022 Oct 17;12(10):398. doi: 10.3390/bs12100398.

  PMID: 36285967 BACKGROUND

• Gonzalez-Puelma J, Aldridge J, Montes de Oca M, Pinto M, Uribe-Paredes R, Fernandez-Goycoolea J, Alvarez-Saravia D, Alvarez H, Encina G, Weitzel T, Munoz R, Olivera-Nappa A, Pantano S, Navarrete MA. Mutation in a SARS-CoV-2 Haplotype from Sub-Antarctic Chile Reveals New Insights into the Spike's Dynamics. Viruses. 2021 May 11;13(5):883. doi: 10.3390/v13050883.

  PMID: 34064904 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

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

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 6, 2023
• Study Start: May 3, 2023
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately after finishing the process of treatment and follow-up, cleaning, quality control and analysis of our data, we will make them available to the research community in general. All data from data made available for public use will be de-identified data, i.e., stripped of private health information and devoid of private and protected health information that could be used to infer the identity of subjects. identity of individual subjects, in accordance with the Standard.
• Access Criteria: Multimodal LongCov-19 Study website to be determined.

Locations

CL (1)