Long COVIDEJerSA-COVIDNCT05848518
Exercise for Health in Patients With Post-acute Sequelae of COVID-19
A study testing Rehabilitation program in people with Long COVID, run by Campus docent Sant Joan de Déu-Universitat de Barcelona at 1 site in Spain.
Trial summary
Background: Many patients with COVID-19 present the so-called post-acute sequelae of COVID-19 such as fatigue, post-stress discomfort, dyspnea, headache, pain mental impairment, incapacity to perform daily physical tasks ant exercise intolerance. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- Rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons of both sexes (and different expression of gender) older than 60 years of age.
- No history of physical diseases and no disease or disability that limits participation in the exercise program or precludes the corresponding measurement/evaluations.
- Be able to communicate without difficulty.
- Be able to understand the objectives of the project and provide informed consent. In this case, the consent form will be signed.
- Not taking any medication that can affect normal performance of the exercise program and the evaluations
Who cannot join
- Having acute or terminal disease or any other disease that may affect the normal practice of a supervised exercise program and the corresponding evaluations.
- Consumption of alcohol or drugs.
- Be performing any type of activity that may interfere in carrying out the supervised exercise program or the evaluations.
- Not completing the study once initiated or wishing to participate in the control group.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Campus Docent Sant Joan de Déu. Universitat de Barcelona
Sant Boi de Llobregat, Barcelona, 08830
About this study
Official title: Effect of Different Types of Supervised Exercise Programs on Cardiorespiratory and Muscular Fitness, Pain, Fatigue, Mental Health and Inflammatory and Oxidative Stress Biomarkers in Older COVID-19 Survivors. (EJerSA-COVID-19)
Background: Many patients with COVID-19 present the so-called post-acute sequelae of COVID-19 such as fatigue, post-stress discomfort, dyspnea, headache, pain mental impairment, incapacity to perform daily physical tasks ant exercise intolerance. This study aims to investigate the effects of different exercise programs on physical and mental fitness, physical condition and biomarkers of the immune system and oxidative stress in older COVID-19 survivors. Methods: The sample will be made up of 120 eligible participants, over the age of 60 years who have had COVID-19 disease and are survivors and present persistent COVID-19 symptomatology diagnosed by the corresponding physician. The participants will be randomly assigned to the experimental groups: supervised endurance group (SEG, n = 30), supervised strength group (SSG, n = 30), supervised concurrent group (SCG, n = 30), which will perform the corresponding exercise program 3 days a week compared to the control group (CG, n = 30), which will not carry out a supervised exercise program. The design of this project will include assessment of cardiorespiratory fitness, muscle fitness, pain and mental health, and biomarkers of inflammation and oxidative stress.
Read the detailed description
This project will carry out a randomized controlled trial to determine what type of supervised exercise program is the most effective compared with a control group (CG): supervised endurance group (SEG), supervised strength group (SSG), supervised concurrent group (strength and endurance) (SCG) and CG. The project will be divided into 3 subprojects and performed in coordination by three institutions as follows:
- Subproject of the consolidated research group on pain, physical activity, nutrition and health (Acronym: DAFNiS) of the Campus Sant Joan de Deu. University of Barcelona. "Effects of a physical exercise program (aerobic, strength or combined/concurrent) on muscle fitness, pain and mental health in older COVID-19 survivors". ii) Subproject of the Hospital of Matar: "Evaluation of cardiorespiratory and muscular fitness in older COVID-19 survivors". iii) Subproject of the Department of Physiology and Immunology. University of Barcelona. "Evaluation of biomarkers of inflammation and oxidative stress in older COVID-19 survivors".
The sample will be made up of 120 eligible participants, over the age of 60 years who have had COVID-19 disease and are survivors and present persistent COVID-19 symptomatology with sequelae of fatigue, muscle weakness, pain, difficulty in performing daily life activities, etc. diagnosed by the corresponding physician. The participants will be recruited from Hospital of Matar. Candidates fulfilling the study inclusion criteria will provide signed informed consent prior to inclusion.
To calculate the sample size of this project a type 1 (α) error of 5% and a 95% confidence interval with a level of precision (d = 0.095) was established for the test of proportional hypotheses resulting in a sample size of n= 108 persons, increased by 10% (rounded up to n=120) to compensate for possible dropouts along the study period.
To know the sample size more precisely in the hypothesis test of means it will be necessary to carry out a pilot study which will provide the size of effect and statistical power (0.80), determine the analysis to perform, obtain delta values in the units corresponding to the principal study variable as well as know the standard deviation.
Program of supervised exercise The intervention will consist in a program of supervised physical exercise performed 3 times a week for 12 weeks. For the planning and control of the exercise program the progressive individualized planning model will be applied based on the subjective perception of effort and cardiorespiratory parameters (heart rate and ventilatory threshold determined in the evaluation tests) of the participants. This program has been used by our research group in previous studies for improving cardiorespiratory and muscle fitness. The basis of this periodization model establishes an initial period of individualization to obtain the personal parameters used for the training load
The COVID-19 survivors will be randomly assigned to 3 programs of supervised exercise :
- Program of endurance exercise. The program of supervised endurance exercise will consist in walking for 1 hour 3 times a week. The intensity (step speed) will gradually be increased each week (approx. 5%) according to the perception of the participant. A pulsometer will be used to determine the safe range of heart rate at which the participant should perform.
- Program of strength exercise This will consist in performing a program of traditional strength 1 hour 3 times a week. Circuit training methodology will be used (10 exercises) alternating muscle groups of the upper and lower extremities and trunk. The initial series be of 1 exercise, evolving to up to 3-4 along the program based on the individual adaptation of the individual. The intensity (load applied) will be gradually increased each week while the recovery times between each exercise activity will be reduced (approx. 5%) according to the perception of the participant. A pulsometer will be used to determine the safe range of heart rate at which the participant should perform.
- Program of concurrent exercise (endurance and strength) The participants will perform 1 hour of concurrent exercise, combining walking (20 minutes) and the strength program for 40 minutes, maintaining the same instructions explained previously in each exercise program.
- Control group The control group will not carry out any supervised exercise program but will maintain their same habits of daily life activities.
Process of evaluation To determine the effects of the exercise program, an initial evaluation will be made before beginning the exercise program to assess the initial status of the participants (Pre). This evaluation will be compared with the evaluation made at the end of the intervention program (Post) at 12 weeks
- Conditions
- Long COVID
- Being tested
- Rehabilitation program
- Keywords
- rehabilitation programs, endurance exercise, resistance exercise, cardiopulmonary exercise testing, muscle strength assessment, quality of life, elderly people, severe acute respiratory syndrome coronavirus 2
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
The participants will be randomly assigned to the experimental groups: supervised endurance rehabilitation program (SEG, n = 30), supervised strength rehabilitation program (SSG, n = 30), supervised concurrent rehabilitation program (SCG, n = 30), and control group (CG, n = 30)
| Study group | Role | What they receive |
|---|---|---|
| Concurrent rehabilitation program | Experimental | Endurance plus resistance exercises Receives: Other: Rehabilitation program |
| Endurance rehabilitation program | Experimental | Endurance exercises Receives: Other: Rehabilitation program |
| Strength rehabilitation program | Experimental | Resistance exercises Receives: Other: Rehabilitation program |
| Control group | No intervention | No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness: absolute oxygen uptake
absolute oxygen uptake (peak VO2) in L/min
Measured: 1 week per group
Cardiorespiratory fitness: relative oxygen uptake
relative oxygen uptake (peak VO2) in mL/kg/min
Measured: 1 week per group
Cardiorespiratory fitness: ventilation
minute ventilation (VE) in L/min.
Measured: 1 week per group
Cardiorespiratory fitness: ventilatory equivalent for oxygen
Ventilatory equivalent for oxygen (VE/VO2)
Measured: 1 week per group
Cardiorespiratory fitness: ventilatory equivalent for carbon dioxide
Ventilatory equivalent for carbon dioxide (VE/VCO2)
Measured: 1 week per group
Cardiorespiratory fitness: respiratory exchange ratio
Respiratory exchange ratio (RER)
Measured: 1 week per group
Cardiorespiratory fitness: End-tidal partial pressure
End-tidal partial pressure of oxygen and carbon dioxide (PetO2 and PetCO2, respectively) in mmHg.
Measured: 1 week per group
Muscular fitness: Sit and stand test
Sit and stand test for 30 seconds. The number of times in 30 seconds the participant can completely stand up from a seated position with the back straight and the feet on the floor without pushing with the arms will be counted.
Measured: 1 week per group
Muscular fitness: countermovement jump
Countermovement jumps: Flight Height in cm
Measured: 1 week per group
Muscular fitness: countermovement test
Countermovement jumps: power output of the lower extremities in watts
Measured: 1 week per group
Muscular fitness: Upper limb strength
This will be evaluated with the bicep curl test made with a 2 kg weight for women and a 4 Kg weight for men. The number of elbow curls made in 30 seconds with each upper limb will be counted.
Measured: 1 week per group
Muscular fitness: hand grip strength
Hand grip strength: Force in Newtons Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered
Measured: 1 week per group
Muscular fitness: Motor Agility/Dynamic balance
Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered in seconds
Measured: 1 week per group
Muscular fitness: Isokinetic strength test
The isokinetic knee flexor and extensor test: peak torque in N m
Measured: 1 week per group
Muscular fitness: Isokinetic strength testing
The isokinetic knee flexor and extensor test: power output in Watts
Measured: 1 week per group
Body composition: fat mass
Fat mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.
Measured: 1 week per group
Body composition: fat free mass
Fat free mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.
Measured: 1 week per group
Body composition: muscle mass
Muscle mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.
Measured: 1 week per group
Concentration of oxidative stress biomarkers: thiobarbituric acid reactive substances
Determination of oxidized lipids by the thiobarbituric acid reactive substances (TBARS) in mmols (fluorimetry technique).
Measured: 1 week per group
Concentration of oxidative stress biomarkers: Advanced Oxidation Protein Products
Determination of oxidized proteins by the Advanced Oxidation Protein Products (AOPP) in nmol Cl-T/mg protein, (colorimetry technique)
Measured: 1 week per group
Concentration of oxidative stress biomarkers: nitrites and nitrates
Determination of nitrites and nitrates (colorimetry) in nmol/mL
Measured: 1 week per group
Concentration of biomarkers of antioxidant enzymes: superoxide dismutase
superoxide dismutase (SOD) in units/mL
Measured: 1 week per group
Concentration of biomarkers of antioxidant enzymes: catalase
catalase (CAT) in units/mL
Measured: 1 week per group
Concentration of biomarkers of antioxidant enzymes: glutathion peroxidase
Glutathion peroxidase (GPx) in units/mL.
Measured: 1 week per group
Concentration of inflammation biomarkers: Interleukines
Interleukin 6 and 10 (IL-6 and IL-10) in ng/mL
Measured: 1 week per group
Concentration of inflammation biomarkers: adiponectin
adiponectin in mg/L
Measured: 1 week per group
Concentration of biomarkers of inflammation: Tumor necrosis factor
Tumor Necrosis Factor-alpha in pg/mL
Measured: 1 week per group
Evaluation of the degree of pain using the pupillometer: pupil diameter
basal and maximum diameter of the pupil in mm
Measured: 1 week per group
Evaluation of the degree of pain using the pupillometer:variation of pupil
percentage of variation of pupil diameter in %
Measured: 1 week per group
Evaluation of the degree of pain using the pupillometer: pupil variation
variation of the pupil in mm
Measured: 1 week per group
Evaluation of the degree of pain using the pupillometer: Intensity of reflex of dilatation
Intensity of reflex of dilatation, latency.
Measured: 1 week per group
Evaluation of the degree of pain with a pressure algometer: algometers
Pain will be quantified with a pressure algometer + pupillometer in older COVID-19 survivors.
A pressure algometer allows the application of a controlled and quantifiable nociceptive stimulus on a body surface.
Algometers apply a pressure stimulus that can be useful for applying a standardized painful stimulus, having a different nature from that applied with the pupillometer which is a stimulus of electric origin.
Measured: 1 week per group
Mental health
Psychosocial variables will be evaluated using the Hospital Anxiety and Depression Scale (HADS), which is made up of 7 items for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) will be scored on a scale of 4 points from 0 (none) to 3 (much more). The highest scores indicate the highest levels of anxiety or depression
Measured: 1 week per group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start15 May 2023
- Primary completion30 Sep 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus docent Sant Joan de Déu-Universitat de Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Mataró, University of Barcelona
- Responsible party
- Principal investigator, Manuel Vicente Garnacho Castano, Campus docent Sant Joan de Déu-Universitat de Barcelona
- Investigators
- Manuel V Garnacho-Castaño, PhD, Principal investigator, Campus docent Sant Joan de Déu-Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848518
- Sponsor's protocol ID
- CampusSantJoan
- Acronym
- EJerSA-COVID
- Status last verified
- Mar 2024
- First submitted
- 2 May 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pleguezuelos E, Sanchez-Nuno S, Del Carmen A, Serra-Paya N, Moreno E, Molina-Raya L, Robleda G, Benet M, Santos-Ruiz S, Garrido AB, Jerez-Molina C, Miravitlles M, Serra-Prat M, Vinals X, Farres MG, Carbonell T, Garnacho-Castano MV. Effect of different types of supervised exercise programs on cardiorespiratory and muscular fitness, pain, fatigue, mental health and inflammatory and oxidative stress biomarkers in older patients with post-COVID-19 sequelae "EJerSA-COVID-19": a randomized controlled trial. BMC Geriatr. 2023 Dec 15;23(1):865. doi: 10.1186/s12877-023-04544-3.
PubMed 38102536
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Types of Supervised Exercise Programs on Cardiorespiratory and Muscular Fitness, Pain, Fatigue, Mental Health and Inflammatory and Oxidative Stress Biomarkers in Older COVID-19 Survivors. (EJerSA-COVID-19)
- ClinicalTrials.gov ID
- NCT05848518
- Acronym / sponsor ID
- EJerSA-COVID / CampusSantJoan
- Conditions
- Long COVID
- Keywords
- rehabilitation programs, endurance exercise, resistance exercise, cardiopulmonary exercise testing, muscle strength assessment, quality of life, elderly people, severe acute respiratory syndrome coronavirus 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Campus docent Sant Joan de Déu-Universitat de BarcelonaUniversity, hospital or other
- Collaborators
- Hospital de Mataró, University of Barcelona
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Many patients with COVID-19 present the so-called post-acute sequelae of COVID-19 such as fatigue, post-stress discomfort, dyspnea, headache, pain mental impairment, incapacity to perform daily physical tasks ant exercise intolerance. This study aims to investigate the effects of different exercise programs on physical and mental fitness, physical condition and biomarkers of the immune system and oxidative stress in older COVID-19 survivors. Methods: The sample will be made up of 120 eligible participants, over the age of 60 years who have had COVID-19 disease and are survivors and present persistent COVID-19 symptomatology diagnosed by the corresponding physician. The participants will be randomly assigned to the experimental groups: supervised endurance group (SEG, n = 30), supervised strength group (SSG, n = 30), supervised concurrent group (SCG, n = 30), which will perform the corresponding exercise program 3 days a week compared to the control group (CG, n = 30), which will not carry out a supervised exercise program. The design of this project will include assessment of cardiorespiratory fitness, muscle fitness, pain and mental health, and biomarkers of inflammation and oxidative stress.
Detailed description
This project will carry out a randomized controlled trial to determine what type of supervised exercise program is the most effective compared with a control group (CG): supervised endurance group (SEG), supervised strength group (SSG), supervised concurrent group (strength and endurance) (SCG) and CG. The project will be divided into 3 subprojects and performed in coordination by three institutions as follows:
- Subproject of the consolidated research group on pain, physical activity, nutrition and health (Acronym: DAFNiS) of the Campus Sant Joan de Deu. University of Barcelona. "Effects of a physical exercise program (aerobic, strength or combined/concurrent) on muscle fitness, pain and mental health in older COVID-19 survivors". ii) Subproject of the Hospital of Matar: "Evaluation of cardiorespiratory and muscular fitness in older COVID-19 survivors". iii) Subproject of the Department of Physiology and Immunology. University of Barcelona. "Evaluation of biomarkers of inflammation and oxidative stress in older COVID-19 survivors".
The sample will be made up of 120 eligible participants, over the age of 60 years who have had COVID-19 disease and are survivors and present persistent COVID-19 symptomatology with sequelae of fatigue, muscle weakness, pain, difficulty in performing daily life activities, etc. diagnosed by the corresponding physician. The participants will be recruited from Hospital of Matar. Candidates fulfilling the study inclusion criteria will provide signed informed consent prior to inclusion.
To calculate the sample size of this project a type 1 (α) error of 5% and a 95% confidence interval with a level of precision (d = 0.095) was established for the test of proportional hypotheses resulting in a sample size of n= 108 persons, increased by 10% (rounded up to n=120) to compensate for possible dropouts along the study period.
To know the sample size more precisely in the hypothesis test of means it will be necessary to carry out a pilot study which will provide the size of effect and statistical power (0.80), determine the analysis to perform, obtain delta values in the units corresponding to the principal study variable as well as know the standard deviation.
Program of supervised exercise The intervention will consist in a program of supervised physical exercise performed 3 times a week for 12 weeks. For the planning and control of the exercise program the progressive individualized planning model will be applied based on the subjective perception of effort and cardiorespiratory parameters (heart rate and ventilatory threshold determined in the evaluation tests) of the participants. This program has been used by our research group in previous studies for improving cardiorespiratory and muscle fitness. The basis of this periodization model establishes an initial period of individualization to obtain the personal parameters used for the training load
The COVID-19 survivors will be randomly assigned to 3 programs of supervised exercise :
- Program of endurance exercise. The program of supervised endurance exercise will consist in walking for 1 hour 3 times a week. The intensity (step speed) will gradually be increased each week (approx. 5%) according to the perception of the participant. A pulsometer will be used to determine the safe range of heart rate at which the participant should perform.
- Program of strength exercise This will consist in performing a program of traditional strength 1 hour 3 times a week. Circuit training methodology will be used (10 exercises) alternating muscle groups of the upper and lower extremities and trunk. The initial series be of 1 exercise, evolving to up to 3-4 along the program based on the individual adaptation of the individual. The intensity (load applied) will be gradually increased each week while the recovery times between each exercise activity will be reduced (approx. 5%) according to the perception of the participant. A pulsometer will be used to determine the safe range of heart rate at which the participant should perform.
- Program of concurrent exercise (endurance and strength) The participants will perform 1 hour of concurrent exercise, combining walking (20 minutes) and the strength program for 40 minutes, maintaining the same instructions explained previously in each exercise program.
- Control group The control group will not carry out any supervised exercise program but will maintain their same habits of daily life activities.
Process of evaluation To determine the effects of the exercise program, an initial evaluation will be made before beginning the exercise program to assess the initial status of the participants (Pre). This evaluation will be compared with the evaluation made at the end of the intervention program (Post) at 12 weeks
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Concurrent rehabilitation program | Experimental | Other: Rehabilitation programEndurance plus resistance exercises |
| Endurance rehabilitation program | Experimental | Other: Rehabilitation programEndurance exercises |
| Strength rehabilitation program | Experimental | Other: Rehabilitation programResistance exercises |
| Control group | No intervention | –No exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persons of both sexes (and different expression of gender) older than 60 years of age.
- No history of physical diseases and no disease or disability that limits participation in the exercise program or precludes the corresponding measurement/evaluations.
- Be able to communicate without difficulty.
- Be able to understand the objectives of the project and provide informed consent. In this case, the consent form will be signed.
- Not taking any medication that can affect normal performance of the exercise program and the evaluations
Key exclusion criteria (4 listed)
- Having acute or terminal disease or any other disease that may affect the normal practice of a supervised exercise program and the corresponding evaluations.
- Consumption of alcohol or drugs.
- Be performing any type of activity that may interfere in carrying out the supervised exercise program or the evaluations.
- Not completing the study once initiated or wishing to participate in the control group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation programThe participants will be randomly assigned to the experimental groups: supervised endurance rehabilitation program (SEG, n = 30), supervised strength rehabilitation program (SSG, n = 30), supervised concurrent rehabilitation program (SCG, n = 30), and control group (CG, n = 30) | Other | Concurrent rehabilitation program, Endurance rehabilitation program, Strength rehabilitation program |
Primary outcome
Cardiorespiratory fitness: absolute oxygen uptake
Time frame: 1 week per group
absolute oxygen uptake (peak VO2) in L/min
Cardiorespiratory fitness: relative oxygen uptake
Time frame: 1 week per group
relative oxygen uptake (peak VO2) in mL/kg/min
Cardiorespiratory fitness: ventilation
Time frame: 1 week per group
minute ventilation (VE) in L/min.
Cardiorespiratory fitness: ventilatory equivalent for oxygen
Time frame: 1 week per group
Ventilatory equivalent for oxygen (VE/VO2)
Cardiorespiratory fitness: ventilatory equivalent for carbon dioxide
Time frame: 1 week per group
Ventilatory equivalent for carbon dioxide (VE/VCO2)
Cardiorespiratory fitness: respiratory exchange ratio
Time frame: 1 week per group
Respiratory exchange ratio (RER)
Cardiorespiratory fitness: End-tidal partial pressure
Time frame: 1 week per group
End-tidal partial pressure of oxygen and carbon dioxide (PetO2 and PetCO2, respectively) in mmHg.
Muscular fitness: Sit and stand test
Time frame: 1 week per group
Sit and stand test for 30 seconds. The number of times in 30 seconds the participant can completely stand up from a seated position with the back straight and the feet on the floor without pushing with the arms will be counted.
Muscular fitness: countermovement jump
Time frame: 1 week per group
Countermovement jumps: Flight Height in cm
Muscular fitness: countermovement test
Time frame: 1 week per group
Countermovement jumps: power output of the lower extremities in watts
Muscular fitness: Upper limb strength
Time frame: 1 week per group
This will be evaluated with the bicep curl test made with a 2 kg weight for women and a 4 Kg weight for men. The number of elbow curls made in 30 seconds with each upper limb will be counted.
Muscular fitness: hand grip strength
Time frame: 1 week per group
Hand grip strength: Force in Newtons Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered
Muscular fitness: Motor Agility/Dynamic balance
Time frame: 1 week per group
Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered in seconds
Muscular fitness: Isokinetic strength test
Time frame: 1 week per group
The isokinetic knee flexor and extensor test: peak torque in N m
Muscular fitness: Isokinetic strength testing
Time frame: 1 week per group
The isokinetic knee flexor and extensor test: power output in Watts
Body composition: fat mass
Time frame: 1 week per group
Fat mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.
Body composition: fat free mass
Time frame: 1 week per group
Fat free mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.
Body composition: muscle mass
Time frame: 1 week per group
Muscle mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.
Concentration of oxidative stress biomarkers: thiobarbituric acid reactive substances
Time frame: 1 week per group
Determination of oxidized lipids by the thiobarbituric acid reactive substances (TBARS) in mmols (fluorimetry technique).
Concentration of oxidative stress biomarkers: Advanced Oxidation Protein Products
Time frame: 1 week per group
Determination of oxidized proteins by the Advanced Oxidation Protein Products (AOPP) in nmol Cl-T/mg protein, (colorimetry technique)
Concentration of oxidative stress biomarkers: nitrites and nitrates
Time frame: 1 week per group
Determination of nitrites and nitrates (colorimetry) in nmol/mL
Concentration of biomarkers of antioxidant enzymes: superoxide dismutase
Time frame: 1 week per group
superoxide dismutase (SOD) in units/mL
Concentration of biomarkers of antioxidant enzymes: catalase
Time frame: 1 week per group
catalase (CAT) in units/mL
Concentration of biomarkers of antioxidant enzymes: glutathion peroxidase
Time frame: 1 week per group
Glutathion peroxidase (GPx) in units/mL.
Concentration of inflammation biomarkers: Interleukines
Time frame: 1 week per group
Interleukin 6 and 10 (IL-6 and IL-10) in ng/mL
Concentration of inflammation biomarkers: adiponectin
Time frame: 1 week per group
adiponectin in mg/L
Concentration of biomarkers of inflammation: Tumor necrosis factor
Time frame: 1 week per group
Tumor Necrosis Factor-alpha in pg/mL
Evaluation of the degree of pain using the pupillometer: pupil diameter
Time frame: 1 week per group
basal and maximum diameter of the pupil in mm
Evaluation of the degree of pain using the pupillometer:variation of pupil
Time frame: 1 week per group
percentage of variation of pupil diameter in %
Evaluation of the degree of pain using the pupillometer: pupil variation
Time frame: 1 week per group
variation of the pupil in mm
Evaluation of the degree of pain using the pupillometer: Intensity of reflex of dilatation
Time frame: 1 week per group
Intensity of reflex of dilatation, latency.
Evaluation of the degree of pain with a pressure algometer: algometers
Time frame: 1 week per group
Pain will be quantified with a pressure algometer + pupillometer in older COVID-19 survivors. A pressure algometer allows the application of a controlled and quantifiable nociceptive stimulus on a body surface. Algometers apply a pressure stimulus that can be useful for applying a standardized painful stimulus, having a different nature from that applied with the pupillometer which is a stimulus of electric origin.
Mental health
Time frame: 1 week per group
Psychosocial variables will be evaluated using the Hospital Anxiety and Depression Scale (HADS), which is made up of 7 items for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) will be scored on a scale of 4 points from 0 (none) to 3 (much more). The highest scores indicate the highest levels of anxiety or depression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 38102536Pleguezuelos E, Sanchez-Nuno S, Del Carmen A, Serra-Paya N, Moreno E, Molina-Raya L, Robleda G, Benet M, Santos-Ruiz S, Garrido AB, Jerez-Molina C, Miravitlles M, Serra-Prat M, Vinals X, Farres MG, Carbonell T, Garnacho-Castano MV. Effect of different types of supervised exercise programs on cardiorespiratory and muscular fitness, pain, fatigue, mental health and inflammatory and oxidative stress biomarkers in older patients with post-COVID-19 sequelae "EJerSA-COVID-19": a randomized controlled trial. BMC Geriatr. 2023 Dec 15;23(1):865. doi: 10.1186/s12877-023-04544-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel V Garnacho-Castaño, PhD principal investigator
Campus docent Sant Joan de Déu-Universitat de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program in people with Long COVID, run by Campus docent Sant Joan de Déu-Universitat de Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness: absolute oxygen uptake (time frame: 1 week per group). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05848518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.