Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06063031
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2023-09-27
Brief Title:
Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition
Sponsor:
Instituto de Investigación Sanitaria Aragón
Organization:
Instituto de Investigación Sanitaria Aragón
Study Overview
Official Title:
Investigation of a Specialized Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition to Improve Their Quality of Life ARACOV-02
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARACOV-02
Brief Summary:
SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19 Once the acute phase of the disease has passed about 40 of the people who discharged continue to have symptoms and of these between 50 and 70 present them up to three months later These persistent symptoms include physical aspects such as fatigue and dyspnea but also cardiac such as palpitations cognitive such as mental confusion and psycho-emotional such as depression anxiety and stress SARS-CoV-2 infection is associated with a hyperinflammatory state including excessive inflammatory cell infiltration inflammasomes activation In this context omega-3 metabolites Special Pro-resolving Mediators-SPMs restore the balance in nutritional and molecular levels of eicosanoids A more direct and targeted way to increase SPMs levels is Omega3 Essential Nutrition with natural SPMs taken by mouth Today there are dietary supplements containing SPMs LIPINOVA made from fish oil through a fractionation process LIPINOVA is a nutritional supplement patented by Solutex GC SL obtained through several fractionation stages extraction purification separation concentration from rich-in-omega-3 fish oil without additives Each capsule contains 498 mg of fish oil and 2 mg of tocopherols This represents a variable quantity from 50 to 150 mg of EPA 20 a variable quantity from 100 to 225 mg of DHA 30 as well as the following quantities of EPA and DHA active metabolites obtained from a pool of natural lipid mediators contained in omega-3 oil 40-200 mcg of 17-HDHA 25-200 mcg of 18-HEPE and 20-100 mcg of 14-HDHA
In addition to this the appearance of this new health condition post-COVID condition has once again led physiotherapists to update themselves in search of the best evidence to guide the examination and necessary rehabilitation interventions in this type of patient Studies have shown how physiotherapy sessions that include a multimodal program could be the most indicated for this type of patients Patients with this condition present an increase in fatigue dyspnea and a decrease in their functional capacity and therefore a decrease in their quality of life due to various pathogenic mechanisms that include chronic hyperinflammation
These patients could obtain greater health improvements in terms of their quality of life if a therapeutical exercise and education program based on tele-rehabilitation is implemented together with a natural nutritional supplement that generates a systemic anti-inflammatory effect through SPMs omega- 3
In addition to this the appearance of this new health condition post-COVID condition has once again led physiotherapists to update themselves in search of the best evidence to guide the examination and necessary rehabilitation interventions in this type of patient Studies have shown how physiotherapy sessions that include a multimodal program could be the most indicated for this type of patients Patients with this condition present an increase in fatigue dyspnea and a decrease in their functional capacity and therefore a decrease in their quality of life due to various pathogenic mechanisms that include chronic hyperinflammation
These patients could obtain greater health improvements in terms of their quality of life if a therapeutical exercise and education program based on tele-rehabilitation is implemented together with a natural nutritional supplement that generates a systemic anti-inflammatory effect through SPMs omega- 3
Detailed Description:
Patients who have contracted COVID-19 usually show various symptoms during the infection Fever cough generalized pain gastrointestinal disturbances dyspnea and fatigue The latter two symptoms occur in about half of patients worldwide although they are even more common in Europe In addition to these respiratory symptoms the disease can also have effects at the muscular neurological and cardiovascular levels
After the acute phase of the disease approximately 40 of discharged patients still have symptoms and of these 50 to 70 have symptoms up to three months later These persistent symptoms include physical aspects such as fatigue and shortness of breath but also cardiac symptoms such as palpitations cognitive symptoms such as mental confusion and psychoemotional symptoms such as depression anxiety and stress
However it is also observed how this clinic can be maintained beyond three months It is known that there is a group of patients about 5-10 who have persistent symptoms over a period of up to 2 years and new symptoms may even appear leading to persistent COVID Although the terminology for designating patients with this persistent clinical condition is changing on October 6 2021 the WHO published a consensus document defining the post-COVID condition CPCOVID
The possible mechanisms contributing to the overall pathophysiology of CPCOVID are still unclear and numerous factors have been proposed to date A key element may be the presence of a state of chronic hyperinflammation In the lung context the virus activates innate immunity leading to a cascade of inflammatory cytokines including interleukin-6 IL -6 IL -1 tumor necrosis factor-alpha and reactive oxygen species Some studies have attempted to demonstrate the presence of T cells and NK lymphocytes in these patients making it appear that COVID is characterized by alterations in TCD4 cells and TCD8 cells
Other proposed mechanisms include autoimmune mechanisms through the presence of autoantibodies that act against modulatory proteins that alter immune function Also the hypercoagulable state thromboinflammatory state associated with SARS-CoV-2 infection is responsible for the disproportionately high rates 20-30 of thrombotic complications observed in patients with COVID-19 and autonomic nervous system involvement leading to autonomic dysfunction
Therefore controlling systemic inflammation and eliminating it in general is as important as eradicating the virus itself In particular omega-3 fatty acids EPA and DHA are substrates that modulate the immune system response by promoting the resolution of inflammation by producing pro-resolving mediators that actively modulate and resolve the immune system response Thus omega-6 ARA and omega-3 fatty acids EPA and DHA are structural lipids but the biological effects are carried out by their naturally produced metabolites SPMs In cases where the acute response of the immune system is chronic deficiency of SPMs in the affected tissues has been observed eg in metabolic diseases obesity metabolic syndrome diabetes type II fatty liver dry eye atherosclerosis autoimmune diseases etc These effects on the metabolic pathways of SPM production may reduce resolution and thus contribute to the chronicity of the inflammatory response
Recently severe COVID-19 was shown to be associated with an altered profile of SPMs compared with healthy individuals SPMs may have a new role in the essential nutritional management of deficiencies of these metabolites in COVID-19 disease
Several recent articles have suggested that the change in prostaglandin profile and the increase in arachidonic acid derivatives may be indicative of the severity of the disease and the chances of recovery in the patient with COVID-19
In addition the emergence of this new health condition CPCOVID has prompted physiotherapists to renew their search for the best evidence to guide the investigative and rehabilitative interventions required for this type of patient Evidence is currently sparse but it is known that cognitive function and emotional health are aspects that need to be considered in the patients treatment plan as well as the dynamics of general condition weakness fatigue concentration dizziness headaches sleep disturbances anxiety debilitating symptoms of decreased aerobic tolerance and subjective feelings of severity of asthenia fatigue physical and mental tiredness decreased motivation and activity Studies have shown that physical therapy sessions that include aerobic exercise resistance aerobic exercise strengthening exercises diaphragmatic breathing techniques and mindfulness training are most appropriate for this type of patient Moreover the use of new information and communication technologies digital health for rehabilitation treatment has also proven effective for other diseases such as cardiac neurological respiratory or musculoskeletal disorders
Objective To evaluate the improvement in quality of life in CPCOVID patients after a 12-week specialized nutritional intervention with natural and standardized SPMs nutritional supplement together with a therapeutic exercise and education program via telerehabilitation compared to a group that underwent the tele-rehabilitation program and no supplements placebo as measured by the Quality of Life Scale EQ-5D
After the acute phase of the disease approximately 40 of discharged patients still have symptoms and of these 50 to 70 have symptoms up to three months later These persistent symptoms include physical aspects such as fatigue and shortness of breath but also cardiac symptoms such as palpitations cognitive symptoms such as mental confusion and psychoemotional symptoms such as depression anxiety and stress
However it is also observed how this clinic can be maintained beyond three months It is known that there is a group of patients about 5-10 who have persistent symptoms over a period of up to 2 years and new symptoms may even appear leading to persistent COVID Although the terminology for designating patients with this persistent clinical condition is changing on October 6 2021 the WHO published a consensus document defining the post-COVID condition CPCOVID
The possible mechanisms contributing to the overall pathophysiology of CPCOVID are still unclear and numerous factors have been proposed to date A key element may be the presence of a state of chronic hyperinflammation In the lung context the virus activates innate immunity leading to a cascade of inflammatory cytokines including interleukin-6 IL -6 IL -1 tumor necrosis factor-alpha and reactive oxygen species Some studies have attempted to demonstrate the presence of T cells and NK lymphocytes in these patients making it appear that COVID is characterized by alterations in TCD4 cells and TCD8 cells
Other proposed mechanisms include autoimmune mechanisms through the presence of autoantibodies that act against modulatory proteins that alter immune function Also the hypercoagulable state thromboinflammatory state associated with SARS-CoV-2 infection is responsible for the disproportionately high rates 20-30 of thrombotic complications observed in patients with COVID-19 and autonomic nervous system involvement leading to autonomic dysfunction
Therefore controlling systemic inflammation and eliminating it in general is as important as eradicating the virus itself In particular omega-3 fatty acids EPA and DHA are substrates that modulate the immune system response by promoting the resolution of inflammation by producing pro-resolving mediators that actively modulate and resolve the immune system response Thus omega-6 ARA and omega-3 fatty acids EPA and DHA are structural lipids but the biological effects are carried out by their naturally produced metabolites SPMs In cases where the acute response of the immune system is chronic deficiency of SPMs in the affected tissues has been observed eg in metabolic diseases obesity metabolic syndrome diabetes type II fatty liver dry eye atherosclerosis autoimmune diseases etc These effects on the metabolic pathways of SPM production may reduce resolution and thus contribute to the chronicity of the inflammatory response
Recently severe COVID-19 was shown to be associated with an altered profile of SPMs compared with healthy individuals SPMs may have a new role in the essential nutritional management of deficiencies of these metabolites in COVID-19 disease
Several recent articles have suggested that the change in prostaglandin profile and the increase in arachidonic acid derivatives may be indicative of the severity of the disease and the chances of recovery in the patient with COVID-19
In addition the emergence of this new health condition CPCOVID has prompted physiotherapists to renew their search for the best evidence to guide the investigative and rehabilitative interventions required for this type of patient Evidence is currently sparse but it is known that cognitive function and emotional health are aspects that need to be considered in the patients treatment plan as well as the dynamics of general condition weakness fatigue concentration dizziness headaches sleep disturbances anxiety debilitating symptoms of decreased aerobic tolerance and subjective feelings of severity of asthenia fatigue physical and mental tiredness decreased motivation and activity Studies have shown that physical therapy sessions that include aerobic exercise resistance aerobic exercise strengthening exercises diaphragmatic breathing techniques and mindfulness training are most appropriate for this type of patient Moreover the use of new information and communication technologies digital health for rehabilitation treatment has also proven effective for other diseases such as cardiac neurological respiratory or musculoskeletal disorders
Objective To evaluate the improvement in quality of life in CPCOVID patients after a 12-week specialized nutritional intervention with natural and standardized SPMs nutritional supplement together with a therapeutic exercise and education program via telerehabilitation compared to a group that underwent the tele-rehabilitation program and no supplements placebo as measured by the Quality of Life Scale EQ-5D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None