NCT05629884

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

December 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

November 18, 2022

Last Update Submit

November 28, 2022

Conditions

SARS-CoV-2 InfectionCOVID-19 RecurrentCognitive DysfunctionFatigue

Keywords

COVID-19SARS-CoV-2Persistent CovidCardiac rehabilitationRespiratory rehabilitationPhysical rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Six Minutes Walking test

    The 6-min walk test is a standard in cardiac rehabilitation, serving both to ecologically determine the patient's functional status and to make recommendations regarding the intensity of rehabilitative exercise. The patient is asked to run the maximum distance he/she can in 6 minutes. The length of one of the hospital corridors has been previously measured so that by counting the number of times the patient walks the distance covered is determined. In addition to the number of meters, the heart rate is monitored by means of a pectoral band, and the saturation level by means of a pulse oximeter; the BP is evaluated before and after the test. In the context of functional assessment of Persistent COVID, it has been used for the evaluation of the impact of rehabilitation measures.

    8 weeks

Secondary Outcomes (6)

  • mMRC dyspnea scale

    8 weeks

  • SF-36 Health Questionnaire

    8 weeks

  • Maximal Handgrip Strenght

    8 weeks

  • 1 Minute Sit to Stand test

    8 weeks

  • P maximal inspiratory and P maximal expiratory

    8 weeks

  • +1 more secondary outcomes

Other Outcomes (11)

  • Age

    8 weeks

  • Sex

    8 weeks

  • Body mass index

    8 weeks

  • +8 more other outcomes

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Other: COPERIA-REHAB

Control arm

NO INTERVENTION

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

Interventions

COPERIA-REHABOTHER

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).

Experimental arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Patients who do not agree to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Vigo, Pontevedra, 36213, Spain

Location

School of Telecommunication Engineering (University of Vigo)

Vigo, Pontevedra, 36310, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, 32002, Spain

Location

S.S. Computer Engineering (University of Vigo)

Ourense, 32004, Spain

Location

MeSH Terms

Conditions

COVID-19Cognitive DysfunctionFatigue

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCognition DisordersNeurocognitive DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Alejandro García Caballero, MD

CONTACT

988 38 55 00alejandro.alberto.garcia.caballero@sergas.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 29, 2022

Study Start

December 14, 2022

Primary Completion

November 14, 2023

Study Completion

November 14, 2023

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations

ES(4)