Efficacy of a Physical and Respiratory Rehabilitation Program for Patients With Persistent COVID-19 (SARS-CoV-2).

NCT ID: NCT05629884

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2023-11-14

Brief Summary

The pandemic caused by SARS-CoV-2 infection has resulted, in addition to the well-known acute symptoms, in the emergence of a plethora of persistent, diffuse and heterogeneous symptoms such as fatigue, shortness of breath and cognitive dysfunction among others, that have come to be called persistent COVID. Patients have reported that physical activity, stress and sleep disturbances often trigger exacerbations of their symptoms related by some authors to the so-called Post Exertional Malaise (PEM) characteristic of Myalgic Encephalomyelitis. Similarly, by analogy with other pathologies, it has been hypothesized that optimal exercise prescription would benefit these people with persistent COVID-19 symptoms but in practice, the rehabilitation of these patients runs the risk of collapsing respiratory and physical rehabilitation services.

This is why COPERIA proposes the construction of a platform for respiratory, cardiac and muscular telerehabilitation, to compare with face-to-face rehabilitation treatment and to try to predict the influence of physical activity in the prediction of PEM.

Conditions

SARS-CoV-2 Infection; COVID-19 Recurrent; Cognitive Dysfunction; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental arm

This group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform.

Group Type: EXPERIMENTAL

COPERIA-REHAB

Intervention Type: OTHER

After the randomization of the patient there will be some preliminary sessions where the means of self-monitoring training and the Borg 1/10 effort scale will be explained and training videos will be shown. Doubts will also be answered.

Afterwards, training will start through the COPERIA-REHAB platform, which will last 8 weeks (6 days per week).

Control arm

This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

COPERIA-REHAB

After the randomization of the patient there will be some preliminary sessions where the means of self-monitoring training and the Borg 1/10 effort scale will be explained and training videos will be shown. Doubts will also be answered.

Afterwards, training will start through the COPERIA-REHAB platform, which will last 8 weeks (6 days per week).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥18 and ≤70 years of age.
• Patients with a diagnosis according to WHO criteria of persistent COVID-19 until 03/28/2022
• Patients with a Post Covid Functional Status (PCFS) ≥ 2.
• Patients who present a need for physical rehabilitation and agree to perform it.
• Patients with capacity to consent and who agree to participate in the study.
• Patients who know how to use Smartphone and/or Tablet and have at least one of these devices.
• Patients who have access to the rehabilitation tools at home or are willing to go to the gyms proposed in the study to perform the rehabilitation exercises.

Exclusion Criteria

• Minors or persons judicially incapacitated.
• Previous neurological or psychiatric pathology involving neuropsychological compromise.
• Active Covid19 infection.
• Home oxygen therapy > 16 hours or home Cpap- Bipap.
• Previous diagnosis of arrhythmia or blockage.
• Previous coronary pathology.
• Decompensated renal or metabolic disease.
• Signs or symptoms of unknown cardiac disease.
• Undergoing another physical or cognitive rehabilitation process at the time of inclusion.
• Patients who do not agree to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vigo

OTHER

Sponsor Role: collaborator

Galician South Health Research Institute

NETWORK

Sponsor Role: collaborator

Fundacin Biomedica Galicia Sur

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

School of Telecommunication Engineering (University of Vigo)

Vigo, Pontevedra, Spain

Complexo Hospitalario Universitario de Ourense

Ourense, , Spain

S.S. Computer Engineering (University of Vigo)

Ourense, , Spain

Countries

Spain

Central Contacts

Alejandro García Caballero, MD

Role: CONTACT

alejandro.alberto.garcia.caballero@sergas.es

988 38 55 00

Facility Contacts

Beatriz Calderón Cruz, PhD

Role: primary

Carmen García Mateo, PhD

Role: primary

Alejandro García Caballero, MD

Role: primary

alejandro.alberto.garcia.caballero@sergas.es

Xose Antón Vila Sobrino, PhD

Role: primary

Other Identifiers

COPERIA-REHAB

Identifier Type: -

Identifier Source: org_study_id