Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition

NCT06063031 | Unknown

• 1 other identifier: C.I. PI22/335
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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 S.L., 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).

Conditions

Post-COVID Condition

Keywords

Fatigue; Telerehabilitation; Functional Status; Physical Therapy; Nutrition Supplement; Multimodal Program; Quality of Life; Psychosocial factors; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Changes in the Quality of life (EQ-5D)

  The EQ-5D is a generic instrument for measuring health-related quality of life that can be used in relatively healthy individuals (general population) as well as in patient groups with various medical conditions. Individuals rate their own health status, first in severity by dimension (descriptive system) and then on a more general visual analog scale (VAS). A third element of the EQ-5D is the index of social values, which is determined for each health status identified by the instrument. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression), each with five severity levels (no problems, mild problems, some problems or moderate problems, and severe problems, cannot occur). In each dimension of the EQ -5D, the severity levels are each coded from 1 to 5.

  Pre-intervention (day 1); after intervention (12 weeks)

Secondary Outcomes (11)

• Changes in the Biomarkers

  Pre-intervention (day 1); after intervention (12 weeks)

• Changes in the Fatigue Severity Scale (FSS)

  Pre-intervention (day 1); after intervention (12 weeks)

• Changes in the Modified Medical Research Council Scale (mMRC)

  Pre-intervention (day 1); after intervention (12 weeks)

• Changes in the Measurements of peak inspiratory pressure and peak expiratory pressure

  Pre-intervention (day 1); after intervention (12 weeks)

• Changes in the Functional capacity as measured by the 6-minute walk

  Pre-intervention (day 1); after intervention (12 weeks)

Other Outcomes (1)

• Clinical parameters and Socio-demographic data

  Pre-intervention (day 1)

Study Arms (2)

Active nutritional supplement plus telerehabilitation

EXPERIMENTAL

Active nutritional supplement plus telerehabilitation

Dietary Supplement: Active

Placebo nutritional supplement plus telerehabilitation

PLACEBO COMPARATOR

Placebo nutritional supplement plus telerehabilitation

Other: Placebo

Interventions

Active DIETARY_SUPPLEMENT

Active nutritional supplement plus telerehabilitation

Active nutritional supplement plus telerehabilitation

Placebo OTHER

Placebo nutritional supplement plus telerehabilitation

Placebo nutritional supplement plus telerehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To have signed the informed consent form.
• Age between 18 and 70 years with access to and knowledge of basic use of technological applications.
• Patients with clinical criteria of having suffered from COVID-19 with diagnosis confirmed by diagnostic techniques and systems in health centers (PCR, rapid antigen test, and/or serology (positive anti-N antibodies).
• Patients who remain symptomatic for more than 12 weeks after the onset of symptoms.
• Patients who manifest symptoms compatible with CPCOVID since the end of the acute phase\*.
• Patients with fatigue greater than or equal to an average of 4 points on the FSS.
• Independent ambulation, even with the use of technical aids.

You may not qualify if:

• Patients with severe neurological diseases at the central and/or peripheral level that prevent them from following the program.
• Patients with respiratory insufficiency: SaO2 \< 90% or respiratory rate ≧30.
• Patients with rheumatic diseases or acute musculoskeletal injuries that do not allow exercise.
• Patients who do not have access to the Internet or are unable to use the Internet on a daily basis.
• Patients with clinical symptoms consistent with chronic fatigue syndrome.
• Presence of symptoms consistent with CPCOVID prior to SARS Cov-2 infection.
• Pregnant or lactating women or women of childbearing age who are trying to become pregnant.
• Patients unable to follow oral and written instructions in Spanish.
• Patients with an allergy to fish, shellfish, or any of the ingredients of the preparation.
• Patients enrolled in another clinical trial for the treatment of symptomatology derived from COVID -19.
• Patients who have completed another clinical trial in the 4 weeks prior to enrollment.
• Patients who have received immunosuppressive medications and/or corticosteroids in the last 2 weeks prior to enrollment. Patients who have received nonsteroidal anti-inflammatory drugs (NSAIDs) continuously or on a fixed regimen in the 2 weeks prior to treatment initiation. Patients who have been taking NSAIDs may have a 7-day withdrawal period.
• Women of childbearing age who are not willing to take NSAIDs should not be treated.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Solutex GC S.L.: collaborator

Study Sites (1)

IIS Aragón

Zaragoza, Spain

Location

Related Publications (1)

• Carpallo-Porcar B, Jimenez-Sanchez C, Calvo S, Irun P, Kolesnyk-Sumskaya E, Aller-Blanco AI, Beamonte EDC. ARACOV-02. Specialized nutritional intervention and telerehabilitation in patients with long COVID: Protocol of a randomized controlled trial. PLoS One. 2025 Apr 29;20(4):e0321811. doi: 10.1371/journal.pone.0321811. eCollection 2025.

  PMID: 40299883 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue; Anxiety Disorders; Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

COVID-19; 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; Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jorge Alamillo Salas, Dr

  SALUD

  PRINCIPAL INVESTIGATOR

• Sandra Calvo Carrión., Dr

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

• Beatriz Carpallo Porcar, MSc

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

• Carolina Jiménez Sánchez, Dr

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

• Ana Isabel Aller Blanco, Dr

  SALUD

  PRINCIPAL INVESTIGATOR

• Elena Kolesnyk Sumskaya, Dr

  SALUD

  PRINCIPAL INVESTIGATOR

• Esther del Corral Beamonte, Dr

  SALUD

  STUDY CHAIR

• Pablo Herrero Gallego, Dr

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicentric, double-blind randomized clinical trial

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 2, 2023
• Study Start: September 26, 2022
• Primary Completion: January 15, 2025
• Study Completion: April 30, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-01

Locations

ES (1)