COVID-19 PandemicNCT05195099
Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.
A study testing respiratory treatment in people with COVID-19 Pandemic, run by Universidad Católica de Ávila at 1 site in Spain.
Trial summary
The objectives are to reduce dyspnoea, increase exertional capacity, increase vital capacity and respiratory muscle strength. vital capacity and respiratory muscle strength. In addition to increasing the sensibility of smell and taste, observing if there is a relationship between the decrease of these senses with the… Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- respiratory treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 17 Jun 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 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age range between 18 and 42 years.
- patients with respiratory sequelae post Covid-19.
- patients with smell and taste sequelae post Covid-19.
Who cannot join
- Under 18 years old.
- Over 42 years old.
- Patients not diagnosed with Covid-19 (PCR positive).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Physiotherapy Respiratory and Neurorehabilitation Treatment Protocol in Patients With COVID-19.
The objectives are to reduce dyspnoea, increase exertional capacity, increase vital capacity and respiratory muscle strength.
vital capacity and respiratory muscle strength. In addition to increasing the sensibility of smell and taste, observing if there is a relationship between the decrease of these senses with the senses with appetite and whether appetite has normalised in post-SARS-CoV-2 patients. It is a randomised and blinded experimental study with a control group where the sample recruited will be 30 patients, with a range of of 30 patients, with an age range of 19-42 years, where they carried out an assessment of spirometry, modified Borg dyspnoea scales and modified Medical Research Council (MMRC), Singapure (MMRC), Singapore Smell and Taste Questionnaire (SSTQ) and weekly smell and taste questionnaire.
taste questionnaire.
- Conditions
- COVID-19 Pandemic
- Being tested
- respiratory treatment
- Keywords
- coronavirus, physiotherapies techniques, physiotherapies specialty, agnosia for taste, breathing exercises
- Medical subject headings
- COVID-19, Coronavirus Infections, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory treatmentOther
Respiratory treatment based on aerobic exercise and treatment of the musculature to reduce dyspnoea and increase the capacity for exertion, neurorehabilitative treatment focusing on the sense of smell and taste to on the sense of smell and taste to increase sensitivity in post Covid-19 subjects.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Other: respiratory treatment |
| respiratory treatment | Experimental | Not described Receives: Other: respiratory treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of spirometry.
modified Borg dyspnoea scales (0, minimum to 10 maximum rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing)
Measured: 1 year
smell and taste
smell and taste questionnaire, maximum score (maximum capacity) 40 points. 0 minimum
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Feb 2022
- Primary completion1 May 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195099
- Sponsor's protocol ID
- 14/01/2022
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lu Y, Li X, Geng D, Mei N, Wu PY, Huang CC, Jia T, Zhao Y, Wang D, Xiao A, Yin B. Cerebral Micro-Structural Changes in COVID-19 Patients - An MRI-based 3-month Follow-up Study. EClinicalMedicine. 2020 Aug;25:100484. doi: 10.1016/j.eclinm.2020.100484. Epub 2020 Aug 3.
PubMed 32838240Alawna M, Amro M, Mohamed AA. Aerobic exercises recommendations and specifications for patients with COVID-19: a systematic review. Eur Rev Med Pharmacol Sci. 2020 Dec;24(24):13049-13055. doi: 10.26355/eurrev_202012_24211.
PubMed 33378057Damm M, Pikart LK, Reimann H, Burkert S, Goktas O, Haxel B, Frey S, Charalampakis I, Beule A, Renner B, Hummel T, Huttenbrink KB. Olfactory training is helpful in postinfectious olfactory loss: a randomized, controlled, multicenter study. Laryngoscope. 2014 Apr;124(4):826-31. doi: 10.1002/lary.24340. Epub 2013 Sep 19.
PubMed 23929687Altundag A, Cayonu M, Kayabasoglu G, Salihoglu M, Tekeli H, Saglam O, Hummel T. Modified olfactory training in patients with postinfectious olfactory loss. Laryngoscope. 2015 Aug;125(8):1763-6. doi: 10.1002/lary.25245. Epub 2015 Jun 2.
PubMed 26031472Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.
PubMed 32253535Wang TJ, Chau B, Lui M, Lam GT, Lin N, Humbert S. Physical Medicine and Rehabilitation and Pulmonary Rehabilitation for COVID-19. Am J Phys Med Rehabil. 2020 Sep;99(9):769-774. doi: 10.1097/PHM.0000000000001505.
PubMed 32541352Sanchez Mila Z, Rodriguez Sanz D, Martin Nieto A, Jimenez Lobo A, Ramos Hernandez M, Campon Chekroun A, Frutos Llanes R, Barragan Casas JM, Velazquez Saornil J. Effects of a respiratory and neurological rehabilitation treatment plan in post Covid-19 affected university students. Randomized clinical study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241255967. doi: 10.1177/14799731241255967.
PubMed 38752418
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Physiotherapy Respiratory and Neurorehabilitation Treatment Protocol in Patients With COVID-19.
- ClinicalTrials.gov ID
- NCT05195099
- Acronym / sponsor ID
- 14/01/2022
- Conditions
- COVID-19 Pandemic
- Keywords
- coronavirus, physiotherapies techniques, physiotherapies specialty, agnosia for taste, breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 18 Jan 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 objectives are to reduce dyspnoea, increase exertional capacity, increase vital capacity and respiratory muscle strength.
vital capacity and respiratory muscle strength. In addition to increasing the sensibility of smell and taste, observing if there is a relationship between the decrease of these senses with the senses with appetite and whether appetite has normalised in post-SARS-CoV-2 patients. It is a randomised and blinded experimental study with a control group where the sample recruited will be 30 patients, with a range of of 30 patients, with an age range of 19-42 years, where they carried out an assessment of spirometry, modified Borg dyspnoea scales and modified Medical Research Council (MMRC), Singapure (MMRC), Singapore Smell and Taste Questionnaire (SSTQ) and weekly smell and taste questionnaire.
taste questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: respiratory treatment |
| respiratory treatment | Experimental | Other: respiratory treatment |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age range between 18 and 42 years.
- patients with respiratory sequelae post Covid-19.
- patients with smell and taste sequelae post Covid-19.
Key exclusion criteria (3 listed)
- Under 18 years old.
- Over 42 years old.
- Patients not diagnosed with Covid-19 (PCR positive).
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 |
|---|---|---|
| respiratory treatmentRespiratory treatment based on aerobic exercise and treatment of the musculature to reduce dyspnoea and increase the capacity for exertion, neurorehabilitative treatment focusing on the sense of smell and taste to on the sense of smell and taste to increase sensitivity in post Covid-19 subjects. | Other | control group, respiratory treatment |
Primary outcome
assessment of spirometry.
Time frame: 1 year
modified Borg dyspnoea scales (0, minimum to 10 maximum rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing)
smell and taste
Time frame: 1 week
smell and taste questionnaire, maximum score (maximum capacity) 40 points. 0 minimum
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 29 Jun 2022.
- Results publication: PubMed 32838240Lu Y, Li X, Geng D, Mei N, Wu PY, Huang CC, Jia T, Zhao Y, Wang D, Xiao A, Yin B. Cerebral Micro-Structural Changes in COVID-19 Patients - An MRI-based 3-month Follow-up Study. EClinicalMedicine. 2020 Aug;25:100484. doi: 10.1016/j.eclinm.2020.100484. Epub 2020 Aug 3.
- Results publication: PubMed 33378057Alawna M, Amro M, Mohamed AA. Aerobic exercises recommendations and specifications for patients with COVID-19: a systematic review. Eur Rev Med Pharmacol Sci. 2020 Dec;24(24):13049-13055. doi: 10.26355/eurrev_202012_24211.
- Results publication: PubMed 23929687Damm M, Pikart LK, Reimann H, Burkert S, Goktas O, Haxel B, Frey S, Charalampakis I, Beule A, Renner B, Hummel T, Huttenbrink KB. Olfactory training is helpful in postinfectious olfactory loss: a randomized, controlled, multicenter study. Laryngoscope. 2014 Apr;124(4):826-31. doi: 10.1002/lary.24340. Epub 2013 Sep 19.
- Results publication: PubMed 26031472Altundag A, Cayonu M, Kayabasoglu G, Salihoglu M, Tekeli H, Saglam O, Hummel T. Modified olfactory training in patients with postinfectious olfactory loss. Laryngoscope. 2015 Aug;125(8):1763-6. doi: 10.1002/lary.25245. Epub 2015 Jun 2.
- Results publication: PubMed 32253535Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.
- Results publication: PubMed 32541352Wang TJ, Chau B, Lui M, Lam GT, Lin N, Humbert S. Physical Medicine and Rehabilitation and Pulmonary Rehabilitation for COVID-19. Am J Phys Med Rehabil. 2020 Sep;99(9):769-774. doi: 10.1097/PHM.0000000000001505.
- Derived from this study: PubMed 38752418Sanchez Mila Z, Rodriguez Sanz D, Martin Nieto A, Jimenez Lobo A, Ramos Hernandez M, Campon Chekroun A, Frutos Llanes R, Barragan Casas JM, Velazquez Saornil J. Effects of a respiratory and neurological rehabilitation treatment plan in post Covid-19 affected university students. Randomized clinical study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241255967. doi: 10.1177/14799731241255967.
- Individual participant dataSharing planned: Undecided
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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 respiratory treatment in people with COVID-19 Pandemic, run by Universidad Católica de Ávila 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 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: finished, as of the sponsor's last update on 29 Jun 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?
assessment of spirometry. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195099, which also lists 7 linked publications.
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 29 Jun 2022.