NCT05031858

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

September 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 28, 2021

Last Update Submit

August 30, 2021

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

Vojta therapyRespiratory physiotherapy

Outcome Measures

Primary Outcomes (3)

  • SpO2

    Oxygen saturation

    3 weeks

  • Breathing frequency

    frequency of respiratory cycles per minute

    3 weeks

  • Stay time

    Days of stay in the intermediate respiratory care unit

    3 weeks

Study Arms (2)

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.

Other: Respiratory physiotherapy

Control Group

ACTIVE COMPARATOR

.Inspiratory techniques, mucociliary clearance techniques (expiratory). Use of inspiratory and expiratory incentives. Employment of mechanical assistants

Other: Respiratory physiotherapy

Interventions

Respiratory physiotherapyOTHER

Respiratory physiotherapy

Control GroupVojta Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • respiratory disease by covid-19

You may not qualify if:

  • patient older than 75 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 28, 2021

First Posted

September 2, 2021

Study Start

September 25, 2021

Primary Completion

December 20, 2021

Study Completion

April 15, 2022

Last Updated

September 2, 2021

Record last verified: 2021-08