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

F

Fundacin Biomedica Galicia Sur

Status

Not yet enrolling

Conditions

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

Treatments

Other: COPERIA-REHAB

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT05629884
COPERIA-REHAB

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

Experimental arm
Experimental group
Description:
This group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform.
Treatment:
Other: COPERIA-REHAB
Control arm
No Intervention group
Description:
This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service.

Trial contacts and locations

4

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Central trial contact

Alejandro García Caballero, MD

Data sourced from clinicaltrials.gov

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