COVID-19 Acute Respiratory Distress SyndromeNCT05866224
Telerehabilitation Program and Detraining in Patients With Post-COVID-19 Sequelae
A study testing Telerehabilitation program in people with COVID-19 Acute Respiratory Distress Syndrome, run by Campus docent Sant Joan de Déu-Universitat de Barcelona at 1 site in Spain.
Trial summary
The primary objective of this study is to evaluate the effects of a 15-week home telerehabilitation program and a detraining period on cardiorespiratory fitness and muscular efficiency in patients with post-COVID-19 sequelae compared to a control group of COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Telerehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 May 2023
- 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
- age > 18 years
- molecular diagnosis (reverse transcription polymerase chain reaction [RT-PCR]) of infection by SARS-CoV-2
- post-COVID-19 symptomatology
Who cannot join
- severe neurological disease
- active oncological disease
- neuromuscular disease and/or orthopedic disorders impeding normal development of cardiopulmonary exercise test
- the absence of signed informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Manuel Vicente Garnacho Castaño
Sant Boi de Llobregat, Barcelona, 08830
About this study
Official title: Effects of a Telerehabilitation Program and Detraining on Cardiorespiratory Fitness in Patients With Post-COVID-19 Sequelae
The primary objective of this study is to evaluate the effects of a 15-week home telerehabilitation program and a detraining period on cardiorespiratory fitness and muscular efficiency in patients with post-COVID-19 sequelae compared to a control group of COVID-19 patients. We hypothesize that cardiorespiratory fitness and muscular efficiency significantly improve in patients who carry out the home telerehabilitation program. However, the cardiorespiratory and muscular adaptations achieved and tolerance to exercise are lost over time as an effect of detraining.
- Being tested
- Telerehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation programOther
The supervised telerehabilitation program will be performed in the home of each patient and supervised by an experienced physiotherapist with more than 4 years of clinical experience in therapeutic exercise for chronic diseases.
| Study group | Role | What they receive |
|---|---|---|
| Supervised home telerehabilitation program | Experimental | COVID-19 patients will perform a total of 15 weeks of a telerehabilitation program combined with aerobic and strength exercises using the circuit training methodology. COVID-19 patients will carry out 3 weekly sessions on non-consecutive days to avoid unnecessary overload and maximize the adaptations, completing a total of 45 sessions Receives: Other: Telerehabilitation program |
| non-supervised control group | No intervention | COVID-19 patients that will not perform the telerehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness: absolute oxygen uptake
absolute peak oxygen uptake in L/min
Measured: 1 week per group
Cardiorespiratory fitness: relative oxygen uptake
relative peak oxygen uptake in L/min
Measured: 1 week per group
Exercise capacity during cardiopulmonary exercise test
Exercise time in minutes and seconds
Measured: 1 week per group
Mechanical efficiency
Delta efficiency in percentage
Measured: 1 week per group
Ventilatory efficiency
VE/VCO2 slope
Measured: 1 week per group
Power output during pedaling
Power output in watts
Measured: 1 week per group
Secondary outcomes (9)
Respiratory exchange ratio
RER
Measured: 1 week per group
Minute ventilation
Ventilation in L/min
Measured: 1 week per group
ventilatory equivalent for oxygen
VE/VO2
Measured: 1 week per group
ventilatory equivalent for carbon dioxide
VE/VCO2
Measured: 1 week per group
End-tidal partial pressure of oxygen
PetO2 in mmHg
Measured: 1 week per group
end-tidal partial pressure of carbon dioxide
PetCO2 in mmHg
Measured: 1 week per group
Weight of COVID-19 patients
Weight in kg
Measured: 1 week per group
Height of COVID-19 patients
Height in meters
Measured: 1 week per group
Body mass index of COVID-19 patients
BMI in kg/m2
Measured: 1 week per group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus docent Sant Joan de Déu-Universitat de Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Vicente Garnacho Castano, Campus docent Sant Joan de Déu-Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866224
- Sponsor's protocol ID
- Hospital of Mataró
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Telerehabilitation Program and Detraining on Cardiorespiratory Fitness in Patients With Post-COVID-19 Sequelae
- ClinicalTrials.gov ID
- NCT05866224
- Acronym / sponsor ID
- Hospital of Mataró
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Campus docent Sant Joan de Déu-Universitat de BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 19 May 2023 (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 primary objective of this study is to evaluate the effects of a 15-week home telerehabilitation program and a detraining period on cardiorespiratory fitness and muscular efficiency in patients with post-COVID-19 sequelae compared to a control group of COVID-19 patients. We hypothesize that cardiorespiratory fitness and muscular efficiency significantly improve in patients who carry out the home telerehabilitation program. However, the cardiorespiratory and muscular adaptations achieved and tolerance to exercise are lost over time as an effect of detraining.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised home telerehabilitation program | Experimental | Other: Telerehabilitation programCOVID-19 patients will perform a total of 15 weeks of a telerehabilitation program combined with aerobic and strength exercises using the circuit training methodology. COVID-19 patients will carry out 3 weekly sessions on non-consecutive days to avoid unnecessary overload and maximize the adaptations, completing a total of 45 sessions |
| non-supervised control group | No intervention | –COVID-19 patients that will not perform the telerehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- molecular diagnosis (reverse transcription polymerase chain reaction [RT-PCR]) of infection by SARS-CoV-2
- post-COVID-19 symptomatology
Key exclusion criteria (4 listed)
- severe neurological disease
- active oncological disease
- neuromuscular disease and/or orthopedic disorders impeding normal development of cardiopulmonary exercise test
- the absence of signed informed consent
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 |
|---|---|---|
| Telerehabilitation programThe supervised telerehabilitation program will be performed in the home of each patient and supervised by an experienced physiotherapist with more than 4 years of clinical experience in therapeutic exercise for chronic diseases. | Other | Supervised home telerehabilitation program |
Primary outcome
Cardiorespiratory fitness: absolute oxygen uptake
Time frame: 1 week per group
absolute peak oxygen uptake in L/min
Cardiorespiratory fitness: relative oxygen uptake
Time frame: 1 week per group
relative peak oxygen uptake in L/min
Exercise capacity during cardiopulmonary exercise test
Time frame: 1 week per group
Exercise time in minutes and seconds
Mechanical efficiency
Time frame: 1 week per group
Delta efficiency in percentage
Ventilatory efficiency
Time frame: 1 week per group
VE/VCO2 slope
Power output during pedaling
Time frame: 1 week per group
Power output in watts
9 secondary outcomes
Respiratory exchange ratio
Time frame: 1 week per group
Minute ventilation
Time frame: 1 week per group
ventilatory equivalent for oxygen
Time frame: 1 week per group
ventilatory equivalent for carbon dioxide
Time frame: 1 week per group
End-tidal partial pressure of oxygen
Time frame: 1 week per group
end-tidal partial pressure of carbon dioxide
Time frame: 1 week per group
Weight of COVID-19 patients
Time frame: 1 week per group
Height of COVID-19 patients
Time frame: 1 week per group
Body mass index of COVID-19 patients
Time frame: 1 week per group
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 May 2023.
- Individual participant dataSharing planned: Undecided. It is not yet decided
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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 Telerehabilitation program in people with COVID-19 Acute Respiratory Distress Syndrome, run by Campus docent Sant Joan de Déu-Universitat de Barcelona 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 3 inclusion and 4 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 May 2023. 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?
Cardiorespiratory fitness: absolute oxygen uptake (time frame: 1 week per group). The study lists 6 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 19 May 2023.