COVID-19 Respiratory InfectionCOVFIS2021NCT05307562
Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection
A study testing Interval training + analytical strength and Interval training + analytical strength and IMT in people with COVID-19 Respiratory Infection and Rehabilitation, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
The purpose of this study is to investigate the effects of a training program in patients that have suffered a COVID infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Respiratory Infection, Rehabilitation, Physical Therapists
- What is being tested?
- Interval training + analytical strength and Interval training + analytical strength and IMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 10 Aug 2021to Dec 2025
- 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
- Men and women ≥18 years
- Patients discharged from the Pulmonology Service with a diagnosis of COVID-19 by positive PCR and with severe pneumonia.
- At least three months after the presence of at least one of the following criteria:
- MRC dyspnea greater than or equal to 2.
- Decrease in the meters walked with respect to the reference values in the 6-minute walking test.
- Decreased respiratory muscle strength measured at Maximum Inspiratory Pressure (PIM) and / or Maximum Expiratory Pressure (PEM) with respect to reference values.
- Sign informed consent from the study
Who cannot join
- Patients who do not want to be included in the study.
- Pregnant women.
- Impossibility to perform ergometry or ultrasound.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of a training program in patients that have suffered a COVID infection
Read the detailed description
Once patients have been selected and meet inclusion criteria, they will sign informed consent. They will make a first visit to obtain the basal parameters. Once done, they will start the individualized training program for 12 weeks 3 times a week.
- Being tested
- Interval training + analytical strength, Interval training + analytical strength and IMT
- Keywords
- covid-19, training program, respiratory physiotherapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval training + analytical strengthOther
Patients will receive a training program
Interval training + analytical strength and IMTOther
Patients will receive a training program + IMT
| Study group | Role | What they receive |
|---|---|---|
| Training program | Active comparator | Global intervallic exercise using cyclometer and analytical strength exercises Receives: Other: Interval training + analytical strength |
| Training program + Inspiratory muscle traioning (IMT) | Experimental | Global intervallic exercise using cyclometer and analytical strength exercises + inspiratory muscles training Receives: Other: Interval training + analytical strength and IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in walking distance in the 6 minutes walk test
6MWT is a submaximal test performed in 30 meters corridor.
Measured: Baseline and 12 weeks after
Secondary outcomes (7)
changes in the maximum watts generated
Cardiopulmonary exercise test will be performed as maximal test
Measured: Baseline and 12 weeks after
changes in (oxygen consumption) VO2 max
Cardiopulmonary exercise test will be performed as maximal test
Measured: Baseline and 12 weeks after
changes in peak VO2
Cardiopulmonary exercise test will be performed as maximal test
Measured: Baseline and 12 weeks after
changes in the diaphragmatic path
Diaphragm echocardiography will be performed
Measured: Baseline and 12 weeks after
changes in diaphragm thickness
Diaphragm echocardiography will be performed
Measured: Baseline and 12 weeks after
changes in diaphragmatic shortening
Diaphragm echocardiography will be performed
Measured: Baseline and 12 weeks after
changes in dyspnea
Measured with mMRC scale (scores from 0-4)
Measured: Baseline and 12 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start10 Aug 2021
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerard Muñoz, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Investigators
- Gerard Muñoz, PhD, Principal investigator, Girona Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307562
- Sponsor's protocol ID
- COVFIS2021
- Acronym
- COVFIS2021
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection
- ClinicalTrials.gov ID
- NCT05307562
- Acronym / sponsor ID
- COVFIS2021 / COVFIS2021
- Keywords
- covid-19, training program, respiratory physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Apr 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.
The purpose of this study is to investigate the effects of a training program in patients that have suffered a COVID infection
Detailed description
Once patients have been selected and meet inclusion criteria, they will sign informed consent. They will make a first visit to obtain the basal parameters. Once done, they will start the individualized training program for 12 weeks 3 times a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training program | Active comparator | Other: Interval training + analytical strengthGlobal intervallic exercise using cyclometer and analytical strength exercises |
| Training program + Inspiratory muscle traioning (IMT) | Experimental | Other: Interval training + analytical strength and IMTGlobal intervallic exercise using cyclometer and analytical strength exercises + inspiratory muscles training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥18 years
- Patients discharged from the Pulmonology Service with a diagnosis of COVID-19 by positive PCR and with severe pneumonia.
- At least three months after the presence of at least one of the following criteria:
- Sign informed consent from the study
Key exclusion criteria (3 listed)
- Patients who do not want to be included in the study.
- Pregnant women.
- Impossibility to perform ergometry or ultrasound.
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 |
|---|---|---|
| Interval training + analytical strengthPatients will receive a training program | Other | Training program |
| Interval training + analytical strength and IMTPatients will receive a training program + IMT | Other | Training program + Inspiratory muscle traioning (IMT) |
Primary outcome
changes in walking distance in the 6 minutes walk test
Time frame: Baseline and 12 weeks after
6MWT is a submaximal test performed in 30 meters corridor.
7 secondary outcomes
changes in the maximum watts generated
Time frame: Baseline and 12 weeks after
changes in (oxygen consumption) VO2 max
Time frame: Baseline and 12 weeks after
changes in peak VO2
Time frame: Baseline and 12 weeks after
changes in the diaphragmatic path
Time frame: Baseline and 12 weeks after
changes in diaphragm thickness
Time frame: Baseline and 12 weeks after
changes in diaphragmatic shortening
Time frame: Baseline and 12 weeks after
changes in dyspnea
Time frame: Baseline and 12 weeks after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
Gerard Muñoz, PhD principal investigator
Girona Biomedical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval training + analytical strength and Interval training + analytical strength and IMT in people with COVID-19 Respiratory Infection and Rehabilitation, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta 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 7 inclusion and 3 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 6 Mar 2024. 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?
changes in walking distance in the 6 minutes walk test (time frame: Baseline and 12 weeks after). 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 6 Mar 2024.