Back to resultsEfficacy of a Physical and Respiratory Rehabilitation Program for Patients With Persistent COVID-19 (SARS-CoV-2). (COPERIA-REHAB)
Primary Purpose
SARS-CoV-2 Infection, COVID-19 Recurrent, Cognitive Dysfunction
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
COPERIA-REHAB
Sponsored by
About this trial
This is an interventional other trial for SARS-CoV-2 Infection focused on measuring COVID-19, SARS-CoV-2, Persistent Covid, Cardiac rehabilitation, Respiratory rehabilitation, Physical rehabilitation
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.
Sites / Locations
- Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
- School of Telecommunication Engineering (University of Vigo)
- Complexo Hospitalario Universitario de Ourense
- S.S. Computer Engineering (University of Vigo)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental arm
Control arm
Arm Description
This group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform.
This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05629884
First Posted
November 18, 2022
Last Updated
November 28, 2022
Sponsor
Fundacin Biomedica Galicia Sur
Collaborators
University of Vigo, Galician South Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05629884
Brief Title
Efficacy of a Physical and Respiratory Rehabilitation Program for Patients With Persistent COVID-19 (SARS-CoV-2).
Acronym
COPERIA-REHAB
Official Title
Efficacy of a Physical and Respiratory Rehabilitation Program (COPERIA-REHAB) for Patients With Persistent COVID-19 (SARS-CoV-2).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 14, 2022 (Anticipated)
Primary Completion Date
November 14, 2023 (Anticipated)
Study Completion Date
November 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacin Biomedica Galicia Sur
Collaborators
University of Vigo, Galician South Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, COVID-19 Recurrent, Cognitive Dysfunction, Fatigue
Keywords
COVID-19, SARS-CoV-2, Persistent Covid, Cardiac rehabilitation, Respiratory rehabilitation, Physical rehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
This group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service.
Intervention Type
Other
Intervention Name(s)
COPERIA-REHAB
Intervention Description
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).
Primary Outcome Measure Information:
Title
Six Minutes Walking test
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
mMRC dyspnea scale
Description
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.
Time Frame
8 weeks
Title
SF-36 Health Questionnaire
Description
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.
Time Frame
8 weeks
Title
Maximal Handgrip Strenght
Description
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.
Time Frame
8 weeks
Title
1 Minute Sit to Stand test
Description
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.
Time Frame
8 weeks
Title
P maximal inspiratory and P maximal expiratory
Description
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.
Time Frame
8 weeks
Title
Insomnia Severity Index.
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Age
Description
Years
Time Frame
8 weeks
Title
Sex
Description
Male, Female
Time Frame
8 weeks
Title
Body mass index
Description
kg/m^2
Time Frame
8 weeks
Title
Current treatment
Description
Treatment taken by the patient at the time of the study.
Time Frame
8 weeks
Title
Date of PCR + SARS-CoV-2
Description
DD-MMM-YYYY
Time Frame
8 weeks
Title
Epidemic wave
Description
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.
Time Frame
8 weeks
Title
Vaccination status at the time of infection
Description
Number of vaccine doses at the time of infection
Time Frame
8 weeks
Title
FVC
Description
Is the maximum volume of air exhaled, with the maximum possible effort, starting from a maximum inspiration in ml.
Time Frame
8 weeks
Title
FEV1
Description
The volume of air expelled during the first second of forced expiration in ml
Time Frame
8 weeks
Title
FEV1/FVC
Description
Expressed as a percentage (%), it indicates the proportion of the FVC that is expelled during the first second of the forced expiratory maneuver.
Time Frame
8 weeks
Title
CO diffusion test
Description
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. (%)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro García Caballero, MD
Phone
988 38 55 00
Email
alejandro.alberto.garcia.caballero@sergas.es
Facility Information:
Facility Name
Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36213
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Calderón Cruz, PhD
Facility Name
School of Telecommunication Engineering (University of Vigo)
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36310
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen García Mateo, PhD
Facility Name
Complexo Hospitalario Universitario de Ourense
City
Ourense
ZIP/Postal Code
32002
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro García Caballero, MD
Email
alejandro.alberto.garcia.caballero@sergas.es
First Name & Middle Initial & Last Name & Degree
Alejandro García Caballero, MD
First Name & Middle Initial & Last Name & Degree
María Bustillo Casado, MD
First Name & Middle Initial & Last Name & Degree
María Dolores Díaz López, MD
First Name & Middle Initial & Last Name & Degree
Genoveva Naval Calviño, MD
First Name & Middle Initial & Last Name & Degree
Pablo López Mato, MD
First Name & Middle Initial & Last Name & Degree
Xoán Miguens Vázquez, MD
First Name & Middle Initial & Last Name & Degree
Coral González Fernández, MD
First Name & Middle Initial & Last Name & Degree
Luis Docasar Bertolo, MD
First Name & Middle Initial & Last Name & Degree
Ana Belén Rodríguez Feijoo, SN
Facility Name
S.S. Computer Engineering (University of Vigo)
City
Ourense
ZIP/Postal Code
32004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xose Antón Vila Sobrino, PhD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Physical and Respiratory Rehabilitation Program for Patients With Persistent COVID-19 (SARS-CoV-2).
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