Covid19RECOVENCT04718506
Rehabilitation for Post-COVID-19 Syndrome Through a Supervised Exercise Intervention
A study testing Exercise and Inspiratory muscle training in people with Covid19 and Post-COVID-19 Syndrome, run by Universidad de Murcia at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Post-COVID-19 Syndrome
- What is being tested?
- Exercise and Inspiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2021to 27 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Post-COVID-19 Syndrome
- Being tested
- Exercise, Inspiratory muscle training, Controls
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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
Inspiratory muscle trainingBehavioural
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
ControlsBehavioural
Controls will be advised (non-supervised) to follow the WHO guidelines: Support for Rehabilitation: Self-Management after COVID-19 Related Illness
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Supervised exercise training Receives: Behavioral: Exercise |
| Inspiratory muscle training | Experimental | Non-supervised inspiratory muscle training protocol Receives: Behavioral: Controls |
| Controls | Active comparator | Non-supervised WHO exercise guidelines Receives: Behavioral: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subject clinical status
Post-COVID Functional Status (PCFS) on a 5-point ordinal scale (0 to 4 grades) and medical screening
Measured: Baseline to 8 Weeks
Secondary outcomes (17)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline to 8 Weeks
Changes in high sensitivity C-reactive protein (hsCPR)
hsCPR (mg/L) determined by blood-based biochemistry analysis
Measured: Baseline to 8 Weeks
Changes in D-dimer
D-dimer (mg/L) determined by blood-based biochemistry analysis
Measured: Baseline to 8 Weeks
Changes in Troponin
Troponin (ng/mL) determined by blood-based biochemistry analysis
Measured: Baseline to 8 Weeks
Changes in glutamic-pyruvic transaminase (GPT)
GPT(IU/L) determined by blood-based biochemistry analysis
Measured: Baseline to 8 Weeks
Changes in serum creatine kinase (CK)
CK (U/L) determined by blood-based biochemistry analysis lactate dehydrogenase (LDH)
Measured: Baseline to 8 Weeks
Changes in lactate dehydrogenase (LDH)
LDH (U/L) determined by blood-based biochemistry analysis
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Baseline to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start12 Jan 2021
- Primary completion6 Feb 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Courel Ibáñez, Universidad de Murcia
- Investigators
- Javier Courel-Ibáñez, Ph.D, Principal investigator, Faculty of Sport Sciences, University of Murcia, Spain.Amaya Jimeno-Almazán, Dr,, Principal investigator, University Hospital of Santa Lucía, Infectious Diseases Section,Jesús García Pallarés, Ph.D, Study director, Faculty of Sport Sciences, University of Murcia, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718506
- Sponsor's protocol ID
- 3036/2020
- Acronym
- RECOVE
- Status last verified
- Aug 2022
- First submitted
- 16 Jan 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation for Post-COVID-19 Syndrome Through a Multicomponent, Educational and Supervised Exercise Intervention [RECOVE]
- ClinicalTrials.gov ID
- NCT04718506
- Acronym / sponsor ID
- RECOVE / 3036/2020
- Conditions
- Covid19, Post-COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 22 Jan 2021 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseSupervised exercise training |
| Inspiratory muscle training | Experimental | Behavioral: ControlsNon-supervised inspiratory muscle training protocol |
| Controls | Active comparator | Behavioral: Inspiratory muscle trainingNon-supervised WHO exercise guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| ExerciseParticipants 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 | Behavioural | Exercise |
| Inspiratory muscle trainingParticipants 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 | Behavioural | Controls |
| ControlsControls will be advised (non-supervised) to follow the WHO guidelines: Support for Rehabilitation: Self-Management after COVID-19 Related Illness | Behavioural | Inspiratory muscle training |
Primary outcome
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
17 secondary outcomes
Changes in cardiovascular fitness: Maximal oxygen consumption (VO2max)
Time frame: Baseline to 8 Weeks
Changes in neuromuscular performance during resistance exercise: Barbell Mean Propulsive Velocity (MPV)
Time frame: Baseline to 8 Weeks
Changes in balance: center of pressure (COP) sway
Time frame: Baseline to 8 Weeks
Changes in pulmonary function: Forced Vital Capacity (FVC)
Time frame: Baseline to 8 Weeks
Changes in pulmonary function: Forced expiratory volume (FEV)
Time frame: Baseline to 8 Weeks
Changes in high sensitivity C-reactive protein (hsCPR)
Time frame: Baseline to 8 Weeks
Changes in D-dimer
Time frame: Baseline to 8 Weeks
Changes in Troponin
Time frame: Baseline to 8 Weeks
Changes in glutamic-pyruvic transaminase (GPT)
Time frame: Baseline to 8 Weeks
Changes in serum creatine kinase (CK)
Time frame: Baseline to 8 Weeks
Changes in lactate dehydrogenase (LDH)
Time frame: Baseline to 8 Weeks
Changes in physical activity levels
Time frame: 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
Changes in fatigue: Chalder Fatigue Scale scale (CFQ-11)
Time frame: Baseline to 8 Weeks
Changes in anxiety: Generalized Anxiety Disorder scale (GAD7)
Time frame: Baseline to 8 Weeks
Changes in depression: Patient Health Questionnaire (PHQ9)
Time frame: Baseline to 8 Weeks
Changes in health related quality of life: 12-item Short Form Survey (SF12)
Time frame: Baseline to 8 Weeks
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 Aug 2022.
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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.
Javier Courel-Ibáñez, Ph.D principal investigator
Faculty of Sport Sciences, University of Murcia, Spain.
Amaya Jimeno-Almazán, Dr, principal investigator
University Hospital of Santa Lucía, Infectious Diseases Section,
Jesús García Pallarés, Ph.D study director
Faculty of Sport Sciences, University of Murcia, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Inspiratory muscle training in people with Covid19 and Post-COVID-19 Syndrome, run by Universidad de Murcia 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 6 inclusion and 14 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 Aug 2022. 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?
Changes in subject clinical status (time frame: Baseline to 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2022.