COVID-19 Acute Respiratory Distress SyndromeNCT05031858
Effect of Vojta Therapy on Covid-19 Respiratory Disease
A study testing Respiratory physiotherapy in people with COVID-19 Acute Respiratory Distress Syndrome, run by NUMEN Foundation.
Trial summary
Vojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Respiratory physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2021to 15 Apr 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- respiratory disease by covid-19
Who cannot join
- patient older than 75 years
About this study
Official title: Effect of Vojta Therapy in Respiratory Disease Caused by SARS-CoV-2. Randomized Controlled Pilot Study
Vojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. The non-invasive and non-painful technique consists of applying tolerable pressure to specific areas of the patient's body. The objective is to activate, in a reflex way, the ventilatory physiology. It is compared with the conventional respiratory physiotherapy approach.
- Being tested
- Respiratory physiotherapy
- Keywords
- Vojta therapy, Respiratory physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory physiotherapyOther
Respiratory physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Vojta Therapy | Experimental | Reflex turn first phase: Patient positioned supine with legs flexed 30º-45º. The pectoral area is stimulated for five minutes on each side x 2 consecutive times. Total 20 minutes per session. Receives: Other: Respiratory physiotherapy |
| Control Group | Active comparator | .Inspiratory techniques, mucociliary clearance techniques (expiratory). Use of inspiratory and expiratory incentives. Employment of mechanical assistants Receives: Other: Respiratory physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2
Oxygen saturation
Measured: 3 weeks
Breathing frequency
frequency of respiratory cycles per minute
Measured: 3 weeks
Stay time
Days of stay in the intermediate respiratory care unit
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start25 Sep 2021 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completion15 Apr 2022 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NUMEN Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Emergencias Enfermera Isabel Zendal de Madrid
- Responsible party
- Principal investigator, Luis Perales Lopez, NUMEN Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031858
- Sponsor's protocol ID
- Numen3
- Status last verified
- Aug 2021
- First submitted
- 28 Aug 2021
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vojta Therapy in Respiratory Disease Caused by SARS-CoV-2. Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05031858
- Acronym / sponsor ID
- Numen3
- Keywords
- Vojta therapy, Respiratory physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NUMEN FoundationUniversity, hospital or other
- Collaborators
- Hospital de Emergencias Enfermera Isabel Zendal de Madrid
- Study start
- 25 Sep 2021 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 2 Sep 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.
Vojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. The non-invasive and non-painful technique consists of applying tolerable pressure to specific areas of the patient's body. The objective is to activate, in a reflex way, the ventilatory physiology. It is compared with the conventional respiratory physiotherapy approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vojta Therapy | Experimental | Other: Respiratory physiotherapyReflex turn first phase: Patient positioned supine with legs flexed 30º-45º. The pectoral area is stimulated for five minutes on each side x 2 consecutive times. Total 20 minutes per session. |
| Control Group | Active comparator | Other: Respiratory physiotherapy.Inspiratory techniques, mucociliary clearance techniques (expiratory). Use of inspiratory and expiratory incentives. Employment of mechanical assistants |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- respiratory disease by covid-19
Key exclusion criteria (1 listed)
- patient older than 75 years
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 physiotherapyRespiratory physiotherapy | Other | Control Group, Vojta Therapy |
Primary outcome
SpO2
Time frame: 3 weeks
Oxygen saturation
Breathing frequency
Time frame: 3 weeks
frequency of respiratory cycles per minute
Stay time
Time frame: 3 weeks
Days of stay in the intermediate respiratory care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
Related trials for COVID-19 Acute Respiratory Distress Syndrome
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingPhase 1/2
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome
Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
RecruitingPhase 1/2
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)
Systemic Inflammatory Response Syndrome
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.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory physiotherapy in people with COVID-19 Acute Respiratory Distress Syndrome, run by NUMEN Foundation.
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 1 inclusion and 1 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
SpO2 (time frame: 3 weeks). The study lists 3 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 2 Sep 2021.