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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Cognitive Dysfunction; SARS-CoV-2 Infection; COVID-19 Recurrent
• Intervention / Treatment: Other: COPERIA-REHAB

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro García Caballero, MD; Phone Number: 988 38 55 00; Email: alejandro.alberto.garcia.caballero@sergas.es

Study Locations

• Spain
  • Ourense, Spain, 32002
    • Complexo Hospitalario Universitario de Ourense
    • Contact: Alejandro García Caballero, MD; Email: alejandro.alberto.garcia.caballero@sergas.es
    • Principal Investigator: Alejandro García Caballero, MD
    • Sub-Investigator: María Bustillo Casado, MD
    • Sub-Investigator: María Dolores Díaz López, MD
    • Sub-Investigator: Pablo López Mato, MD
    • Sub-Investigator: Luis Docasar Bertolo, MD
    • Sub-Investigator: Genoveva Naval Calviño, MD
    • Sub-Investigator: Xoán Miguens Vázquez, MD
    • Sub-Investigator: Coral González Fernández, MD
    • Sub-Investigator: Ana Belén Rodríguez Feijoo, SN
  • Ourense, Spain, 32004
    • S.S. Computer Engineering (University of Vigo)
    • Contact: Xose Antón Vila Sobrino, PhD
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36213
      • Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
      • Contact: Beatriz Calderón Cruz, PhD
    • Vigo, Pontevedra, Spain, 36310
      • School of Telecommunication Engineering (University of Vigo)
      • Contact: Carmen García Mateo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; This group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform.	Other: 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).
No Intervention: Control arm; This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mMRC dyspnea scale	The MRC shortness of breath scale consists of five statements that describe almost the entire range of respiratory disability, from none (Grade 1) to almost complete disability (Grade 5). It can be self-administered by asking subjects to choose the statement that best describes their condition, e.g., "'I am only short of breath with strenuous exertion" (Grade 1) or "I am so short of breath that I cannot leave the house" (Grade 5). Alternatively, it can be administered by an interviewer asking the questions, such as "Are you short of breath when rushing on level ground or when climbing a gentle slope?" (Grade 2). The score is the number that best matches the patient's activity level.	8 weeks
SF-36 Health Questionnaire	The SF-36 Health Questionnaire is composed of 36 items that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical Function, Physical Role, Bodily Pain, General Health, Vitality, Social Function, Emotional Role, and Mental Health. Additionally, the SF-36 includes a transition item that asks about the change in general health status from the previous year.	8 weeks
Maximal Handgrip Strenght	Handgrip strength (HGS) is measured by a handgrip dynamometer and is considered an indicator of overall muscle strength. Low muscle strength, also known as dynapenia is an important indicator of health status, as well as an indicator of sarcopenia. Maximal grip strength is determined by performing three grip attempts at maximum power.	8 weeks
1 Minute Sit to Stand test	Consists of sitting down and getting up from a chair without resting the hands as many times as possible for 1 minute with the patient connected to the saturator and monitored with a chest strap. The minute is timed, the number of repetitions performed is counted, the oxygen saturation value and heart rate are observed and the patient waits 1 minute after the exercise to record again the recovery of the basal parameters.	8 weeks
P maximal inspiratory and P maximal expiratory	These tests will be performed by the Pneumology Service. The measurement of maximal inspiratory and expiratory pressures are well tolerated and relatively easy to perform, they allow estimating the neuromuscular function of the diaphragm, as well as the abdominal, intercostal and accessory muscles. In general terms, the Pimax test estimates the strength of inspiratory muscles (diaphragm) and the Pemax test estimates the strength of abdominal and intercostal muscles. The tests consist of the patient having to generate maximum inspiratory and expiratory pressures against an occluded mouthpiece.	8 weeks
Insomnia Severity Index.	This instrument for the assessment of insomnia consists of 7 questions that are rated between 0 and 4 points. It evaluates both the insomnia of conciliation, maintenance and early awakening, as well as its functional repercussions during the day.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Years	8 weeks
Sex	Male, Female	8 weeks
Current treatment	Treatment taken by the patient at the time of the study.	8 weeks
Date of PCR + SARS-CoV-2	DD-MMM-YYYY	8 weeks
Epidemic wave	Of the 7 waves of COVID-19 that have occurred in Spain, a description will be given of the wave to which the infection of each patient included belonged. First, second, third, fourth, fifth, sixth, seventh, eighth, ninth or tenth wave.	8 weeks
FVC	Is the maximum volume of air exhaled, with the maximum possible effort, starting from a maximum inspiration in ml.	8 weeks
CO diffusion test	To evaluate the transfer of oxygen from the alveolar space to the hemoglobin of the erythrocytes contained in the pulmonary capillaries. Effective alveolar-capillary area available for gas transfer in the lung. (%)	8 weeks
Body mass index	kg/m^2	8 weeks
Vaccination status at the time of infection	Number of vaccine doses at the time of infection	8 weeks
FEV1	The volume of air expelled during the first second of forced expiration in ml	8 weeks
FEV1/FVC	Expressed as a percentage (%), it indicates the proportion of the FVC that is expelled during the first second of the forced expiratory maneuver.	8 weeks

Collaborators and Investigators

• Sponsor: Fundacin Biomedica Galicia Sur
• Collaborators: University of Vigo; Galician South Health Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): December 14, 2022
• Primary Completion (Anticipated): November 14, 2023
• Study Completion (Anticipated): November 14, 2023

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Cardiac rehabilitation; Respiratory rehabilitation; Persistent Covid; Physical rehabilitation
• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurocognitive Disorders; Cognition Disorders; COVID-19; Cognitive Dysfunction
• Other Study ID Numbers: COPERIA-REHAB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No