COVID-19CON-VIDANCT05543408
Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"
A study testing EXERCISE in people with COVID-19 and Long COVID, run by Universidad San Jorge at 1 site in Spain.
Trial summary
This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19, Long COVID, Post-COVID-19 Syndrome
- What is being tested?
- EXERCISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 3 May 2022to 31 Oct 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People over 18 years of age.
- Persistent symptoms of COVID >3 months of duration since infection.
- Have no medical contraindications incompatible with the practice of exercise.
- Do not meet the general 2020 recommendations for physical activity established by the World Health Organization2 (i.e., at least 150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week).
- Provide signed informed consent.
Who cannot join
- Presence of uncontrolled serious medical illness.
- Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over).
Read the detailed description
This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over). 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 both ambulatory and hospitalized post-COVID-19 syndrome patients. The main novelty of this trial compared to other exercise-based interventions is the development and proof of concept of a progressively, levelled exercise regime for people with physical activity intolerance and fatigue symptoms.
- Conditions
- COVID-19, Long COVID, Post-COVID-19 Syndrome
- Being tested
- EXERCISE
- 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
individualized, progressive, exercise program
| Study group | Role | What they receive |
|---|---|---|
| EXERCISE | Experimental | Not described Receives: Behavioral: EXERCISE |
| CONTROL | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Limb Strength: 30 s Sit-to-Stand test
The test starts with the participant seated on a chair (43.2 cm), arms crossed at the wrists and held against the chest. From this position, participants will conduct as much as sit-to-stand repetitions, as fast as possible, during 30 s
Measured: Baseline to 8 weeks
Change in Lower Limb Strength: 5 times Sit-to-Stand Test
Participants will have to sit and stand 5 times (as quickly as possible) from a chair (43.2 cm), arms crossed at the wrists and held against the chest. Time will be register.
Measured: Baseline to 8 weeks
Change in Handgrip Strength
Start by holding the instrument in the testing hand. Squeeze the dynamometer handle as hard as possible to obtain peak force values.
Measured: Baseline to 8 weeks
Chance in upper limbs strength: Arm Curl Biceps
The subject sits on chair, holding the weight in the hand using suitcase grip, with the arm in a vertically downward position beside the chair. Curl the arm up through a full range of motion, gradually returns to the starting position. The arm must be fully bent and then fully straightened at the elbow. The aim of this test is to do as many arm curl as possible in 30 seconds.
Measured: Baseline to 8 weeks
Change in Balance: Flamingo Balance Test
Number of seconds keeping balance with one foot on the floor and the other resting on the opposite ankle (maximum 60 s)
Measured: Baseline to 8 weeks
Change in walking speed: Brisk Walking Test
Number of seconds required to walk 30 m.
Measured: Baseline to 8 weeks
Change in cardiovascular fitness: 6-Minute Walk Test
Number of meters that can be walked in 6 min around 30 m track.
Measured: Baseline to 8 weeks
Change in pulmonary function: Inspiratory and Expiratory Pressures
The maximal inspiratory pressure (MIP) and Maximum Expiratory Pressure (MEP) reflects the respiratory muscles ability to generate force during a short quasi-static contraction.
MIP and MEP measurements are conducted with a manometer that measures mouth pressure and these depend on the motivation and co-ordination of the patient.
Procedures:
- MIP: from tidal breathing the patient slowly exhales as deeply as possible. During expiration the measurement is started manually. The shutter will be set as soon as the patient starts to breathe in. Now the patient is asked to inspire as fast and as powerful as possible against the shutter. The maximal inspiratory pressure will be reached after about 0.5-1 s.
- MEP: from tidal breathing the patient slowly breathes in as deeply as possible. The shutter will be closed with expiration onset. Now the patient is asked to expire as fast and as powerful as possible against the shutter.
Measured: Baseline to 8 weeks
Change in pulmonary function: Peak flow Test
Peak expiratory flow measurement (peak flow) is a simple measure of the maximal flow rate that can be achieved during forceful expiration following full inspiration.
First, the patient should reset the meter by sliding the marker all the way to zero on the scale. While sitting or standing up straight, the patient should take in a full, deep breath. The mouthpiece is then placed in the patient's mouth followed by a single, fast, forceful expiration. The marker will slide outward on the numbered scale, indicating the peak expiratory flow rate for that attempt.
Measured: Baseline to 8 weeks
Secondary outcomes (8)
Body Composition
Bio-Electrical Impedance Analysis (BIA) with 200 kg maximum capacity and 50 g error margin (TANITA BC-418MA, Tanita Corp., Tokyo, Japan).The meassurement includes: body weight (kg) body fat mass, the percentage of body fat (BF%) and the fat-free mass (FFM). Body mass index (BMI) will be calculated dividing weight (kg) by squared height (m2).
Measured: Baseline to 8 weeks
Change in Quality of Life-SF-36
The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: Baseline to 8 weeks
Change in The International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.
Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
Measured: Baseline to 8 weeks
Change in Modified Medical Research Council dyspnea scale (mMRC)
The mMRC Dyspnea Scale is used to assess the degree of baseline functional disability due to dyspnea in patients with respiratory problems. The mMRC breathlessness scale ranges from grade 0 to 4 (low to high).
Measured: Baseline to 8 weeks
Change in Modified Fatigue Impact Scale (MFIS)
The MFIS measures the impact fatigue takes on a patient's daily life. It consists of 21 items divided into 3 subdivision containing 9 physical items , 10 cognitive items and 2 psychosocial. All the items are rated from 0-4 .
The sum of all the questions are calculated where 84 is the highest score. Highest the score means higher the impact of fatigue in daily living.
Measured: Baseline to 8 weeks
Change in Hospital Anxiety and Depression Scale (HADS)
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.
Measured: Baseline to 8 weeks
Change in the short form of the DePaul Symptom Questionnaire (DSQ-SF)
The short for of the DSQ-SF is a self-report measure of demographic characteristics, myalgic encephalomyelitis and chronic fatigue syndrome symptomatology, and medical, occupational, and social history.
Measured: Baseline to 8 weeks
Change in the Insommia Severity Index (ISI)
The ISI is composed of seven items that evaluate the severity of sleep disturbance during the past 2 week
- The first three items assess the severity of difficulties with falling sleep, maintaining sleep, and early morning awakening.
The last four items capture satisfaction with the current sleep patte, interference with daily functioning, noticeability of impairment, and degree of distress caused by the sleep problem.
The scores of each of the seven items range from 0 to 4 (0 = none; 4 = very severe), and a total score can be calculated by summing the seven items, giving a range from 0 to 28, with higher scores indicating greater insomnia severity. Total scores are interpreted as 0-7, absence of insomnia; 8-14, sub-threshold insomnia; 15-21, moderate insomnia; 22-28, severe insomnia.
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 posted16 Sep 2022
- Study start3 May 2022
- Primary completion2 Aug 2022
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Sagarra, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543408
- Sponsor's protocol ID
- Universidad San Jorge
- Acronym
- CON-VIDA
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 22 Sep 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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"
- ClinicalTrials.gov ID
- NCT05543408
- Acronym / sponsor ID
- CON-VIDA / Universidad San Jorge
- Conditions
- COVID-19, Long COVID, Post-COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 16 Sep 2022 (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 an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over).
Detailed description
This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over). 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 both ambulatory and hospitalized post-COVID-19 syndrome patients. The main novelty of this trial compared to other exercise-based interventions is the development and proof of concept of a progressively, levelled exercise regime for people with physical activity intolerance and fatigue symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXERCISE | Experimental | Behavioral: EXERCISE |
| CONTROL | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People over 18 years of age.
- Persistent symptoms of COVID >3 months of duration since infection.
- Have no medical contraindications incompatible with the practice of exercise.
- Do not meet the general 2020 recommendations for physical activity established by the World Health Organization2 (i.e., at least 150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week).
- Provide signed informed consent.
Key exclusion criteria (2 listed)
- Presence of uncontrolled serious medical illness.
- Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study.
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 |
|---|---|---|
| EXERCISEindividualized, progressive, exercise program | Behavioural | EXERCISE |
Primary outcome
Change in Lower Limb Strength: 30 s Sit-to-Stand test
Time frame: Baseline to 8 weeks
The test starts with the participant seated on a chair (43.2 cm), arms crossed at the wrists and held against the chest. From this position, participants will conduct as much as sit-to-stand repetitions, as fast as possible, during 30 s
Change in Lower Limb Strength: 5 times Sit-to-Stand Test
Time frame: Baseline to 8 weeks
Participants will have to sit and stand 5 times (as quickly as possible) from a chair (43.2 cm), arms crossed at the wrists and held against the chest. Time will be register.
Change in Handgrip Strength
Time frame: Baseline to 8 weeks
Start by holding the instrument in the testing hand. Squeeze the dynamometer handle as hard as possible to obtain peak force values.
Chance in upper limbs strength: Arm Curl Biceps
Time frame: Baseline to 8 weeks
The subject sits on chair, holding the weight in the hand using suitcase grip, with the arm in a vertically downward position beside the chair. Curl the arm up through a full range of motion, gradually returns to the starting position. The arm must be fully bent and then fully straightened at the elbow. The aim of this test is to do as many arm curl as possible in 30 seconds.
Change in Balance: Flamingo Balance Test
Time frame: Baseline to 8 weeks
Number of seconds keeping balance with one foot on the floor and the other resting on the opposite ankle (maximum 60 s)
Change in walking speed: Brisk Walking Test
Time frame: Baseline to 8 weeks
Number of seconds required to walk 30 m.
Change in cardiovascular fitness: 6-Minute Walk Test
Time frame: Baseline to 8 weeks
Number of meters that can be walked in 6 min around 30 m track.
Change in pulmonary function: Inspiratory and Expiratory Pressures
Time frame: Baseline to 8 weeks
The maximal inspiratory pressure (MIP) and Maximum Expiratory Pressure (MEP) reflects the respiratory muscles ability to generate force during a short quasi-static contraction. MIP and MEP measurements are conducted with a manometer that measures mouth pressure and these depend on the motivation and co-ordination of the patient. Procedures: * MIP: from tidal breathing the patient slowly exhales as deeply as possible. During expiration the measurement is started manually. The shutter will be set as soon as the patient starts to breathe in. Now the patient is asked to inspire as fast and as powerful as possible against the shutter. The maximal inspiratory pressure will be reached after about 0.5-1 s. * MEP: from tidal breathing the patient slowly breathes in as deeply as possible. The shutter will be closed with expiration onset. Now the patient is asked to expire as fast and as powerful as possible against the shutter.
Change in pulmonary function: Peak flow Test
Time frame: Baseline to 8 weeks
Peak expiratory flow measurement (peak flow) is a simple measure of the maximal flow rate that can be achieved during forceful expiration following full inspiration. First, the patient should reset the meter by sliding the marker all the way to zero on the scale. While sitting or standing up straight, the patient should take in a full, deep breath. The mouthpiece is then placed in the patient's mouth followed by a single, fast, forceful expiration. The marker will slide outward on the numbered scale, indicating the peak expiratory flow rate for that attempt.
8 secondary outcomes
Body Composition
Time frame: Baseline to 8 weeks
Change in Quality of Life-SF-36
Time frame: Baseline to 8 weeks
Change in The International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline to 8 weeks
Change in Modified Medical Research Council dyspnea scale (mMRC)
Time frame: Baseline to 8 weeks
Change in Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline to 8 weeks
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline to 8 weeks
Change in the short form of the DePaul Symptom Questionnaire (DSQ-SF)
Time frame: Baseline to 8 weeks
Change in the Insommia Severity Index (ISI)
Time frame: Baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with COVID-19 and Long COVID, run by Universidad San Jorge 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 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 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?
Results are not available in the source record.
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?
Change in Lower Limb Strength: 30 s Sit-to-Stand test (time frame: Baseline to 8 weeks). The study lists 9 primary outcomes in all. 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 22 Sep 2022.