Back to resultsMultimodal Long Covid19 (MLongCovid)
Primary Purpose
Long COVID-19 Syndrome
Status
Active
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Multimodal intervention in Long Covid19
Sponsored by
About this trial
This is an interventional treatment trial for Long COVID-19 Syndrome focused on measuring Multimodal, Covid19
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).
Sites / Locations
- Universidad de Magallanes
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Multimodal rehabilitation: physical, psychological and cognitive training and treatment program at the Teaching and Research Assistance Center of the University of Magellanus.
Individuals who must maintain their daily habits and/or usual care at their health center.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cardiorespiratory profiles
Fatigue Assessment Scale (FAS) - The FAS questionnaire consists of 10 questions and its objective is to investigate the presence of fatigue in a patient, its response is by means of a likert-type scale in which higher scores imply a greater degree of fatigue, its measurement parameters are based on two categories whose maximum score is 50 points. FAS scores 10 - 21: no fatigue (normal) FAS scores 22 - 50: substantial fatigue
Cardiorespiratory profiles
Test Time Up and GO - Its objective is to evaluate the dynamic balance, as well as the functional capacity and mobility of a person to perform activities of daily living. establishing mobility parameters in such a way that the more time used, the lower the mobility capacity. Less than 10 seconds: independent mobility. Between 10 and 20 seconds: mostly independent mobility. More than 20 seconds: reduced mobility.
Cardiorespiratory profiles
Six-minute walk test - The 6-minute walk test is a submaximal exercise test used to assess aerobic capacity and endurance. The distance walked for a time of 6 minutes is used as a result to compare changes in performance capacity. The more meters the patient runs, the better his cardiorespiratory functional capacity. If a patient reaches 304 meters in the 6 minutes, he achieves cardiorespiratory functional independence category, if he achieves less than that distance, a decrease in cardiorespiratory functional capacity is established.
Psychological profiles
Beck Anxiety Scale - consists of a 21-item self-administered instrument in which the patient is asked to report the extent to which he or she has been affected by each of the 21 symptoms described in the scale. Each item has four possible response options: not at all, mildly, moderately and severely. Values from 0 to 3 are assigned to each of the items. The values for each item are summed to obtain a total score that can range from 0 to 63 points. A total between 0 and 7 points is interpreted as a minimum level of anxiety, between 8 to 15 points corresponds to a mild level of anxiety, from 16 to 25 points is moderate anxiety and from 26 to 63 points is considered severe anxiety.
Psychological profiles
Beck Depression Scale - It consists of a 21-item self-administered instrument designed to assess the severity of depressive symptomatology in adults. In each of the items, the person has to choose, from a set of four alternatives ordered from least to most severe, the statement that best describes his or her state during the last two weeks, including the day on which he or she completes the instrument. As for the correction, each item is valued from 0 to 3 points depending on the alternative chosen and, after directly adding the score of each item, a total score can be obtained that varies from 0 to 63 points; thus, its categories range from minimal depression (0-13); mild depression (14-19), moderate depression (20-28) and severe depression (29-63).
Neurocognitive profiles
Montreal Cognitive Assessment - This instrument examines cognitive dysfunctions associated with attention, concentration, executive functions (including abstraction capacity), memory, language, visuoconstructive abilities, calculation and orientation. The maximum score is 30 points and its score is proportional to the level of cognitive functionality, so that the lower the score, the greater the cognitive impairment. A score equal to or higher than 26 points is considered normal; a score lower than 10 points implies incipient cognitive impairment; from 20 to 23 points: Mild cognitive impairment and if the patient achieves 26 points or more, there is no alteration of cognitive functions.
Functional profiles
Barthel Index - It is a test that provides ranges with scores between 0 and 100, regarding the level of functional behavioral independence for a patient. The closer a subject's score is to 0, the more dependent he/she is; the closer to 100, the more independent he/she is. Based on the results obtained in the evaluation with the Barthel Index or Scale, the classification will be: Total Dependent (less than 20 points), Severe Dependence (20 - 35 points), Moderate Dependence (40 - 55 points), Mild Dependence (greater than or equal to 60 points) and Independence (100 points).
Quality of life indicators
Short Form 12 Health Survey - Health related quality of life questionnaire. The response options of the SF-12 form Likert-type scales that evaluate intensity or frequency of quality of life indicators associated with health. The number of response options ranges from three to six, depending on the item, and each question is given a value that is then transformed into a scale from 0 to 100. The scores have a mean of 50 with a standard deviation of 10, so that values above 50 indicate better health-related quality of life or below 50 indicate a worse state of health-related quality of life.
Nutritional profile
Body composition analyzer - This instrument establishes the level of body fat in people, establishing frames of reference with scores differentiated by sex, classifying as low range in men when their score is less than 9.9%, and women less than 17.9%; normal level: Men between 10 to 19.9%, women between 18 to 27.9%; High: Men between 20 to 58%, women between 28.0 to 58%. Therefore, the higher the percentage, the higher the degree of health risks associated with overweight.
Full Information
NCT ID
NCT05932797
First Posted
June 22, 2023
Last Updated
July 5, 2023
Sponsor
Universidad de Magallanes
Collaborators
Teaching Assistance and Research Center of the University of Magallanes CADI-UMAG, Clinical Hospital Dr. Lautaro Navarro Avaria
1. Study Identification
Unique Protocol Identification Number
NCT05932797
Brief Title
Multimodal Long Covid19
Acronym
MLongCovid
Official Title
EVALUATION AND IMPLEMENTATION OF A MULTIMODAL INTERVENTION TO REDUCE SYMPTOMS OF LONG COVID/PROLONGED COVID IN THE ADULT POPULATION OF PUNTA ARENAS, CHILE.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
November 18, 2024 (Anticipated)
Study Completion Date
November 18, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Magallanes
Collaborators
Teaching Assistance and Research Center of the University of Magallanes CADI-UMAG, Clinical Hospital Dr. Lautaro Navarro Avaria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID-19 Syndrome
Keywords
Multimodal, Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Multimodal rehabilitation: physical, psychological and cognitive training and treatment program at the Teaching and Research Assistance Center of the University of Magellanus.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Individuals who must maintain their daily habits and/or usual care at their health center.
Intervention Type
Other
Intervention Name(s)
Multimodal intervention in Long Covid19
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events assessed by Cardiorespiratory Capacity
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Cardiorespiratory profiles
Description
Fatigue Assessment Scale (FAS) - The FAS questionnaire consists of 10 questions and its objective is to investigate the presence of fatigue in a patient, its response is by means of a likert-type scale in which higher scores imply a greater degree of fatigue, its measurement parameters are based on two categories whose maximum score is 50 points. FAS scores 10 - 21: no fatigue (normal) FAS scores 22 - 50: substantial fatigue
Time Frame
24 months
Title
Cardiorespiratory profiles
Description
Test Time Up and GO - Its objective is to evaluate the dynamic balance, as well as the functional capacity and mobility of a person to perform activities of daily living. establishing mobility parameters in such a way that the more time used, the lower the mobility capacity. Less than 10 seconds: independent mobility. Between 10 and 20 seconds: mostly independent mobility. More than 20 seconds: reduced mobility.
Time Frame
24 months
Title
Cardiorespiratory profiles
Description
Six-minute walk test - The 6-minute walk test is a submaximal exercise test used to assess aerobic capacity and endurance. The distance walked for a time of 6 minutes is used as a result to compare changes in performance capacity. The more meters the patient runs, the better his cardiorespiratory functional capacity. If a patient reaches 304 meters in the 6 minutes, he achieves cardiorespiratory functional independence category, if he achieves less than that distance, a decrease in cardiorespiratory functional capacity is established.
Time Frame
24 months
Title
Psychological profiles
Description
Beck Anxiety Scale - consists of a 21-item self-administered instrument in which the patient is asked to report the extent to which he or she has been affected by each of the 21 symptoms described in the scale. Each item has four possible response options: not at all, mildly, moderately and severely. Values from 0 to 3 are assigned to each of the items. The values for each item are summed to obtain a total score that can range from 0 to 63 points. A total between 0 and 7 points is interpreted as a minimum level of anxiety, between 8 to 15 points corresponds to a mild level of anxiety, from 16 to 25 points is moderate anxiety and from 26 to 63 points is considered severe anxiety.
Time Frame
24 months
Title
Psychological profiles
Description
Beck Depression Scale - It consists of a 21-item self-administered instrument designed to assess the severity of depressive symptomatology in adults. In each of the items, the person has to choose, from a set of four alternatives ordered from least to most severe, the statement that best describes his or her state during the last two weeks, including the day on which he or she completes the instrument. As for the correction, each item is valued from 0 to 3 points depending on the alternative chosen and, after directly adding the score of each item, a total score can be obtained that varies from 0 to 63 points; thus, its categories range from minimal depression (0-13); mild depression (14-19), moderate depression (20-28) and severe depression (29-63).
Time Frame
24 months
Title
Neurocognitive profiles
Description
Montreal Cognitive Assessment - This instrument examines cognitive dysfunctions associated with attention, concentration, executive functions (including abstraction capacity), memory, language, visuoconstructive abilities, calculation and orientation. The maximum score is 30 points and its score is proportional to the level of cognitive functionality, so that the lower the score, the greater the cognitive impairment. A score equal to or higher than 26 points is considered normal; a score lower than 10 points implies incipient cognitive impairment; from 20 to 23 points: Mild cognitive impairment and if the patient achieves 26 points or more, there is no alteration of cognitive functions.
Time Frame
24 months
Title
Functional profiles
Description
Barthel Index - It is a test that provides ranges with scores between 0 and 100, regarding the level of functional behavioral independence for a patient. The closer a subject's score is to 0, the more dependent he/she is; the closer to 100, the more independent he/she is. Based on the results obtained in the evaluation with the Barthel Index or Scale, the classification will be: Total Dependent (less than 20 points), Severe Dependence (20 - 35 points), Moderate Dependence (40 - 55 points), Mild Dependence (greater than or equal to 60 points) and Independence (100 points).
Time Frame
24 months
Title
Quality of life indicators
Description
Short Form 12 Health Survey - Health related quality of life questionnaire. The response options of the SF-12 form Likert-type scales that evaluate intensity or frequency of quality of life indicators associated with health. The number of response options ranges from three to six, depending on the item, and each question is given a value that is then transformed into a scale from 0 to 100. The scores have a mean of 50 with a standard deviation of 10, so that values above 50 indicate better health-related quality of life or below 50 indicate a worse state of health-related quality of life.
Time Frame
24 months
Title
Nutritional profile
Description
Body composition analyzer - This instrument establishes the level of body fat in people, establishing frames of reference with scores differentiated by sex, classifying as low range in men when their score is less than 9.9%, and women less than 17.9%; normal level: Men between 10 to 19.9%, women between 18 to 27.9%; High: Men between 20 to 58%, women between 28.0 to 58%. Therefore, the higher the percentage, the higher the degree of health risks associated with overweight.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Universidad de Magallanes
City
Punta Arenas
State/Province
Provincia De Magallanes
ZIP/Postal Code
6200000
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data Will be Shared is all the individual participant data collected during the trial, after deidentification.
Supporting information:
IPD Sharing 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.
IPD Sharing Access Criteria
Multimodal LongCov-19 Study website to be determined.
Citations:
PubMed Identifier
37113165
Citation
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.
Results Reference
background
PubMed Identifier
36285967
Citation
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.
Results Reference
background
PubMed Identifier
34064904
Citation
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.
Results Reference
background
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Multimodal Long Covid19
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