An interventional study of Rehabilitation program in Long COVID, sponsored by Campus docent Sant Joan de Déu-Universitat de Barcelona. Completed at 1 site in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Campus docent Sant Joan de Déu-Universitat de Barcelona · Not applicable, Interventional, and Basic science
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.
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:
i) 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 :
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 120 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Campus docent Sant Joan de Déu-Universitat de Barcelona is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Endurance plus resistance exercises
Other: Rehabilitation program
Endurance exercises
Other: Rehabilitation program
Resistance exercises
Other: Rehabilitation program
No exercise
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)
Cardiorespiratory fitness: absolute oxygen uptake
absolute oxygen uptake (peak VO2) in L/min
Time frame: 1 week per group
Cardiorespiratory fitness: relative oxygen uptake
relative oxygen uptake (peak VO2) in mL/kg/min
Time frame: 1 week per group
Cardiorespiratory fitness: ventilation
minute ventilation (VE) in L/min.
Time frame: 1 week per group
Cardiorespiratory fitness: ventilatory equivalent for oxygen
Ventilatory equivalent for oxygen (VE/VO2)
Time frame: 1 week per group
Cardiorespiratory fitness: ventilatory equivalent for carbon dioxide
Ventilatory equivalent for carbon dioxide (VE/VCO2)
Time frame: 1 week per group
Cardiorespiratory fitness: respiratory exchange ratio
Respiratory exchange ratio (RER)
Time frame: 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.
Time frame: 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.
Time frame: 1 week per group
Muscular fitness: countermovement jump
Countermovement jumps: Flight Height in cm
Time frame: 1 week per group
Muscular fitness: countermovement test
Countermovement jumps: power output of the lower extremities in watts
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 1 week per group
Muscular fitness: Isokinetic strength test
The isokinetic knee flexor and extensor test: peak torque in N m
Time frame: 1 week per group
Muscular fitness: Isokinetic strength testing
The isokinetic knee flexor and extensor test: power output in Watts
Time frame: 1 week per group
Body composition: fat mass
Fat mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.
Time frame: 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.
Time frame: 1 week per group
Body composition: muscle mass
Muscle mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.
Time frame: 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).
Time frame: 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)
Time frame: 1 week per group
Concentration of oxidative stress biomarkers: nitrites and nitrates
Determination of nitrites and nitrates (colorimetry) in nmol/mL
Time frame: 1 week per group
Concentration of biomarkers of antioxidant enzymes: superoxide dismutase
superoxide dismutase (SOD) in units/mL
Time frame: 1 week per group
Concentration of biomarkers of antioxidant enzymes: catalase
catalase (CAT) in units/mL
Time frame: 1 week per group
Concentration of biomarkers of antioxidant enzymes: glutathion peroxidase
Glutathion peroxidase (GPx) in units/mL.
Time frame: 1 week per group
Concentration of inflammation biomarkers: Interleukines
Interleukin 6 and 10 (IL-6 and IL-10) in ng/mL
Time frame: 1 week per group
Concentration of inflammation biomarkers: adiponectin
adiponectin in mg/L
Time frame: 1 week per group
Concentration of biomarkers of inflammation: Tumor necrosis factor
Tumor Necrosis Factor-alpha in pg/mL
Time frame: 1 week per group
Evaluation of the degree of pain using the pupillometer: pupil diameter
basal and maximum diameter of the pupil in mm
Time frame: 1 week per group
Evaluation of the degree of pain using the pupillometer:variation of pupil
percentage of variation of pupil diameter in %
Time frame: 1 week per group
Evaluation of the degree of pain using the pupillometer: pupil variation
variation of the pupil in mm
Time frame: 1 week per group
Evaluation of the degree of pain using the pupillometer: Intensity of reflex of dilatation
Intensity of reflex of dilatation, latency.
Time frame: 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.
Time frame: 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
Time frame: 1 week per group
Plan to share: No
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Campus docent Sant Joan de Déu-Universitat de Barcelona