An interventional study of Exercise and Inspiratory muscle training in Covid19 and Post-COVID-19 Syndrome, sponsored by Universidad de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-19.
Sponsored by Universidad de Murcia · Not applicable, Interventional, and Treatment
This is a randomized controlled trial of the efficacy of a tailored exercise program, based on multicomponent exercise training and/or inspiratory muscle training, compared to the WHO self-management leaflet commonly used in outpatient scenarios, on the recovery of persistent symptoms and functional limitations after COVID-19.
. The primary objective of the study is to evaluate the clinical efficacy and safety of a tailored exercise-based treatment relative to the control arm in improving the subject clinical status in ambulatory patients.
A fraction \~10% of the COVID-19 patients who undergo a variable acute symptomatic phase of the disease are coming forward with continuing effects of the disease over a month, with chronic complaints like mental fog, delayed latent periods in recalling events of recent past, tachycardia, extreme fatigue, inability to perform daily physical tasks and likely to develop stress, depression, irritability, insomnia, fear, confusion, anger and frustration. This condition is defined as post-COVID-19 syndrome and increasingly affecting a high number of people as the pandemic evolves.
The post-COVID-19 syndrome has become a usual situation in the evolutionary course of the disease with its own entity. The National Health Service (NHS) of UK has recently published a clinical guide for long-term management of the effects of COVID-19 with a comprehensive plan for the assessment and care of patients who present or develop symptoms from the fourth week after diagnosis.
The effective long-term management of the effects of COVID-19 is a challenge that requires awareness. The RECOVE project aims at determining the role of exercise in the treatment of post-COVID-19 syndrome ambulatory patients.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 83 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Universidad de Murcia is the lead sponsor of 77 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Supervised exercise training
Behavioral: Exercise
Non-supervised inspiratory muscle training protocol
Behavioral: Controls
Non-supervised WHO exercise guidelines
Behavioral: Inspiratory muscle training
Participants from the experimental group will complete 8 weeks of a tailored, educational and supervised multicomponent exercise program adapted from the ACSM guidelines for Chronic Obstructive Pulmonary Disease and Cardiovascular Disease. Participants will complete a 3-days-a-week concurrent training routine: two days of resistance training (50% 1RM (one-repetition maximum), 3 sets, 8 repetitions, 4 exercises \[squat, bench press, deadlift and bench pull\]) combined with Moderate Intensity Variable Training (MIVT: 4-6 x 3-5 min at 70-80% Heart Rate Reserve (HRR) / 2-3 min at 55-65% HRR), and one day of Light Intensity Continuous Training (LICT: 30-60 min, 65-70% HRR). Progressions will be individualized and consistent with patient tolerance. Sessions will be supervised by certified strength and conditioning coaches, Graduated in Sports Sciences
Participants enrolled in the inspiratory muscle training protocol will used the PowerBreath® Classic Heath Series mechanic threshold devices to perform 1 set of 30 repetitions, twice a day, every day of the week. This assumes a work intensity of approximately 62.5% ± 4.6% of the PIM (maximum inspiratory pressure). Increase in resistance will be made every two weeks by turning the load adjustment clockwise ¼ to 1 full turn, pending on participant tolerance to maintain a 12-15 RPE on modified Borg scale. The training will be preceded by a warm-up at 80% of the 30 RM load, with 2 min of rest between sets
Controls will be advised (non-supervised) to follow the WHO guidelines: Support for Rehabilitation: Self-Management after COVID-19 Related Illness
Changes in subject clinical status
Post-COVID Functional Status (PCFS) on a 5-point ordinal scale (0 to 4 grades) and medical screening
Time frame: Baseline to 8 Weeks
Changes in cardiovascular fitness: Maximal oxygen consumption (VO2max)
VO2max estimated from standard algorithms using a submaximal multistage and individualized cardiopulmonary exercise test on cycloergometer. Heart rate (HR), rate of perceive effort (RPE) and load (W) will be combined to report VO2max in mml/kg/min.
Time frame: Baseline to 8 Weeks
Changes in neuromuscular performance during resistance exercise: Barbell Mean Propulsive Velocity (MPV)
Barbell displacement and velocity will be monitored in real time using a linear transductor during a progressive resistance training exercise tests. Displacement and velocity will be combined to report MPV
Time frame: Baseline to 8 Weeks
Changes in balance: center of pressure (COP) sway
COP sway during a balance test will be measured using a high resolution force plate
Time frame: Baseline to 8 Weeks
Changes in pulmonary function: Forced Vital Capacity (FVC)
The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry.
Time frame: Baseline to 8 Weeks
Changes in pulmonary function: Forced expiratory volume (FEV)
The amount of air exhaled (mL) during the first (FEV1), second (FEV2), and third seconds (FEV3) of the forced breath will be measured by spirometry.
Time frame: Baseline to 8 Weeks
Changes in high sensitivity C-reactive protein (hsCPR)
hsCPR (mg/L) determined by blood-based biochemistry analysis
Time frame: Baseline to 8 Weeks
Changes in D-dimer
D-dimer (mg/L) determined by blood-based biochemistry analysis
Time frame: Baseline to 8 Weeks
Changes in Troponin
Troponin (ng/mL) determined by blood-based biochemistry analysis
Time frame: Baseline to 8 Weeks
Changes in glutamic-pyruvic transaminase (GPT)
GPT(IU/L) determined by blood-based biochemistry analysis
Time frame: Baseline to 8 Weeks
Changes in serum creatine kinase (CK)
CK (U/L) determined by blood-based biochemistry analysis lactate dehydrogenase (LDH)
Time frame: Baseline to 8 Weeks
Changes in lactate dehydrogenase (LDH)
LDH (U/L) determined by blood-based biochemistry analysis
Time frame: Baseline to 8 Weeks
Changes in physical activity levels
Metabolic Equivalents (METs) throughout a week, including activity for work, during transport and leisure time, using the self-reported general physical activity questionnaire (GPAQ)
Time frame: Baseline to 8 Weeks
Changes in tolerance to exercise: DePaul Symptom Questionnaire for Post-exertional malaise (DSQ-PEM) scores
DSQ-PEM will be administrate to obtain a score of tolerance to exercise (DSQ-PEM Scoring depends on the 10-item mixed questionnaire including scale and yes/no questions)
Time frame: Baseline to 8 Weeks
Changes in fatigue: Chalder Fatigue Scale scale (CFQ-11)
CFQ-11 will be administrate to obtain a score of fatigue (Each of the 11 items are answered on a 4-point scale ranging from the asymptomatic to maximum symptomology)
Time frame: Baseline to 8 Weeks
Changes in anxiety: Generalized Anxiety Disorder scale (GAD7)
GAD7 will be administrate to obtain a score of anxiety status (total score for the seven items ranges from 0 to 21)
Time frame: Baseline to 8 Weeks
Changes in depression: Patient Health Questionnaire (PHQ9)
PHQ9 will be administrate to obtain a score of depression status (total score for the nine items ranges from 0 to 27)
Time frame: Baseline to 8 Weeks
Changes in health related quality of life: 12-item Short Form Survey (SF12)
Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores will be reported as Z-scores (difference compared to the population average, measured in standard deviations).
Time frame: Baseline to 8 Weeks
Changes in Percent Body Fat
Body composition will be measured by bioelectrical impedance analysis
Time frame: Baseline to 8 Weeks
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad de Murcia