- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04718506
Rehabilitation for Post-COVID-19 Syndrome Through a Supervised Exercise Intervention (RECOVE)
Rehabilitation for Post-COVID-19 Syndrome Through a Multicomponent, Educational and Supervised Exercise Intervention [RECOVE]
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
San Javier
-
Murcia, San Javier, Spain, 30720
- Faculty of Sport Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- SARS-CoV-2 diagnosed using real-time reverse transcriptase polymerase chain reaction (PCR) tests or positive for SARS-CoV-2 virus antigen >90 days before randomization.
- Still present a chronic symptomatic phase lasting >90 days since debut of symptoms
- Have not been hospitalized
- There is no evidence on clinical records of pneumonia or any other organ failure related to SARS-CoV-2
- Non-coincident participation in any intervention trial
- Capable and willing to provide an informed consent
Exclusion Criteria:
- Refusal to participate expressed by patient or legally authorized representative if they are present
- Pregnancy or breast-feeding.
- Acute heart attack (recent 3-6 months) or unstable angina
- Uncontrolled atrial or ventricular arrhythmias
- Aortic dissecting aneurysm
- Severe aortic stenosis
- Acute endocarditis / pericarditis
- Uncontrolled high blood pressure (>180/100 mmHg)
- Acute thromboembolism
- Acute or severe heart failure
- Acute or severe respiratory failure
- Uncontrolled acute decompensated diabetes mellitus or low blood sugar
- A recent fracture in the last month.
- Conditions preventing cooperation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
Supervised exercise 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
|
Experimental: Inspiratory muscle training
Non-supervised inspiratory muscle training protocol
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Controls will be advised (non-supervised) to follow the WHO guidelines: Support for Rehabilitation: Self-Management after COVID-19 Related Illness
|
Active Comparator: Controls
Non-supervised WHO exercise guidelines
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in subject clinical status
Time Frame: Baseline to 8 Weeks
|
Post-COVID Functional Status (PCFS) on a 5-point ordinal scale (0 to 4 grades) and medical screening
|
Baseline to 8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cardiovascular fitness: Maximal oxygen consumption (VO2max)
Time Frame: Baseline to 8 Weeks
|
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.
|
Baseline to 8 Weeks
|
Changes in neuromuscular performance during resistance exercise: Barbell Mean Propulsive Velocity (MPV)
Time Frame: Baseline to 8 Weeks
|
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
|
Baseline to 8 Weeks
|
Changes in balance: center of pressure (COP) sway
Time Frame: Baseline to 8 Weeks
|
COP sway during a balance test will be measured using a high resolution force plate
|
Baseline to 8 Weeks
|
Changes in pulmonary function: Forced Vital Capacity (FVC)
Time Frame: Baseline to 8 Weeks
|
The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry.
|
Baseline to 8 Weeks
|
Changes in pulmonary function: Forced expiratory volume (FEV)
Time Frame: Baseline to 8 Weeks
|
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.
|
Baseline to 8 Weeks
|
Changes in high sensitivity C-reactive protein (hsCPR)
Time Frame: Baseline to 8 Weeks
|
hsCPR (mg/L) determined by blood-based biochemistry analysis
|
Baseline to 8 Weeks
|
Changes in D-dimer
Time Frame: Baseline to 8 Weeks
|
D-dimer (mg/L) determined by blood-based biochemistry analysis
|
Baseline to 8 Weeks
|
Changes in Troponin
Time Frame: Baseline to 8 Weeks
|
Troponin (ng/mL) determined by blood-based biochemistry analysis
|
Baseline to 8 Weeks
|
Changes in glutamic-pyruvic transaminase (GPT)
Time Frame: Baseline to 8 Weeks
|
GPT(IU/L) determined by blood-based biochemistry analysis
|
Baseline to 8 Weeks
|
Changes in serum creatine kinase (CK)
Time Frame: Baseline to 8 Weeks
|
CK (U/L) determined by blood-based biochemistry analysis lactate dehydrogenase (LDH)
|
Baseline to 8 Weeks
|
Changes in lactate dehydrogenase (LDH)
Time Frame: Baseline to 8 Weeks
|
LDH (U/L) determined by blood-based biochemistry analysis
|
Baseline to 8 Weeks
|
Changes in physical activity levels
Time Frame: Baseline to 8 Weeks
|
Metabolic Equivalents (METs) throughout a week, including activity for work, during transport and leisure time, using the self-reported general physical activity questionnaire (GPAQ)
|
Baseline to 8 Weeks
|
Changes in tolerance to exercise: DePaul Symptom Questionnaire for Post-exertional malaise (DSQ-PEM) scores
Time Frame: Baseline to 8 Weeks
|
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)
|
Baseline to 8 Weeks
|
Changes in fatigue: Chalder Fatigue Scale scale (CFQ-11)
Time Frame: Baseline to 8 Weeks
|
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)
|
Baseline to 8 Weeks
|
Changes in anxiety: Generalized Anxiety Disorder scale (GAD7)
Time Frame: Baseline to 8 Weeks
|
GAD7 will be administrate to obtain a score of anxiety status (total score for the seven items ranges from 0 to 21)
|
Baseline to 8 Weeks
|
Changes in depression: Patient Health Questionnaire (PHQ9)
Time Frame: Baseline to 8 Weeks
|
PHQ9 will be administrate to obtain a score of depression status (total score for the nine items ranges from 0 to 27)
|
Baseline to 8 Weeks
|
Changes in health related quality of life: 12-item Short Form Survey (SF12)
Time Frame: Baseline to 8 Weeks
|
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).
|
Baseline to 8 Weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Percent Body Fat
Time Frame: Baseline to 8 Weeks
|
Body composition will be measured by bioelectrical impedance analysis
|
Baseline to 8 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javier Courel-Ibáñez, Ph.D, Faculty of Sport Sciences, University of Murcia, Spain.
- Principal Investigator: Amaya Jimeno-Almazán, Dr,, University Hospital of Santa Lucía, Infectious Diseases Section,
- Study Director: Jesús García Pallarés, Ph.D, Faculty of Sport Sciences, University of Murcia, Spain.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3036/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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