Clinical trial NCT05629884: Efficacy of a Physical and Respiratory Rehabilitation Program for Patients With Persistent COVID-19 (SARS-CoV-2).
Official title: Efficacy of a Physical and Respiratory Rehabilitation Program (COPERIA-REHAB) for Patients With Persistent COVID-19 (SARS-CoV-2).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV-2 Infection
COVID-19 Recurrent
Cognitive Dysfunction
Fatigue
Keywords: COVID-19
SARS-CoV-2
Persistent Covid
Cardiac rehabilitation
Respiratory rehabilitation
Physical rehabilitation
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
Collaborators: name: University of Vigo
name: Galician South Health Research Institute
First posted: 2022-11-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Six Minutes Walking test
timeFrame: 8 weeks
Secondary outcomes:
measure: mMRC dyspnea scale
timeFrame: 8 weeks
measure: SF-36 Health Questionnaire
timeFrame: 8 weeks
measure: Maximal Handgrip Strenght
timeFrame: 8 weeks
measure: 1 Minute Sit to Stand test
timeFrame: 8 weeks
measure: P maximal inspiratory and P maximal expiratory
timeFrame: 8 weeks
measure: Insomnia Severity Index.
timeFrame: 8 weeks
Other outcomes:
measure: Age
timeFrame: 8 weeks
measure: Sex
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
measure: Current treatment
timeFrame: 8 weeks
measure: Date of PCR + SARS-CoV-2
timeFrame: 8 weeks
measure: Epidemic wave
timeFrame: 8 weeks
measure: Vaccination status at the time of infection
timeFrame: 8 weeks
measure: FVC
timeFrame: 8 weeks
measure: FEV1
timeFrame: 8 weeks
measure: FEV1/FVC
timeFrame: 8 weeks
measure: CO diffusion test
timeFrame: 8 weeks
Locations:
city: Vigo
country: Spain
facility: Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
state: Pontevedra
city: Vigo
country: Spain
facility: School of Telecommunication Engineering (University of Vigo)
state: Pontevedra
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Ourense
country: Spain
facility: S.S. Computer Engineering (University of Vigo)
Study officials:
References: