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Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05195099
Recruitment Status : Completed
First Posted : January 18, 2022
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
COVID-19 Pandemic Other: respiratory treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Physiotherapy Respiratory and Neurorehabilitation Treatment Protocol in Patients With COVID-19.
Actual Study Start Date : February 1, 2022
Actual Primary Completion Date : May 1, 2022
Actual Study Completion Date : June 17, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: control group Other: respiratory treatment
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.
Experimental: respiratory treatment Other: respiratory treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. smell and taste [ Time Frame: 1 week ]
    smell and taste questionnaire, maximum score (maximum capacity) 40 points. 0 minimum


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age range between 18 and 42 years.
  • patients with respiratory sequelae post Covid-19.
  • patients with smell and taste sequelae post Covid-19.

Exclusion Criteria:

  • Under 18 years old.
  • Over 42 years old.
  • Patients not diagnosed with Covid-19 (PCR positive).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195099


Locations
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Spain
Universidad Católica de Ávila
Ávila, Spain, 05005
Sponsors and Collaborators
Universidad Católica de Ávila
More Information
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Publications of Results:

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Responsible Party: JORGE VELAZQUEZ SAORNIL, Principal Investigator, Universidad Católica de Ávila
ClinicalTrials.gov Identifier: NCT05195099    
Other Study ID Numbers: 14/01/2022
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila:
coronavirus
physiotherapies techniques
physiotherapies specialty
agnosia for taste
breathing exercises
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases