Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.
Primary Purpose
COVID-19 Pandemic
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
respiratory treatment
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pandemic focused on measuring coronavirus, physiotherapies techniques, physiotherapies specialty, agnosia for taste, breathing exercises
Eligibility 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).
Sites / Locations
- Universidad Católica de Ávila
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
respiratory treatment
Arm Description
Outcomes
Primary Outcome Measures
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)
smell and taste
smell and taste questionnaire, maximum score (maximum capacity) 40 points. 0 minimum
Secondary Outcome Measures
Full Information
NCT ID
NCT05195099
First Posted
January 14, 2022
Last Updated
June 23, 2022
Sponsor
Universidad Católica de Ávila
1. Study Identification
Unique Protocol Identification Number
NCT05195099
Brief Title
Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.
Official Title
Effectiveness of a Physiotherapy Respiratory and Neurorehabilitation Treatment Protocol in Patients With COVID-19.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
June 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica de Ávila
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic
Keywords
coronavirus, physiotherapies techniques, physiotherapies specialty, agnosia for taste, breathing exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Title
respiratory treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
respiratory treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
assessment of spirometry.
Description
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)
Time Frame
1 year
Title
smell and taste
Description
smell and taste questionnaire, maximum score (maximum capacity) 40 points. 0 minimum
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Universidad Católica de Ávila
City
Ávila
ZIP/Postal Code
05005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32838240
Citation
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.
Results Reference
result
PubMed Identifier
33378057
Citation
Alawna 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 Reference
result
PubMed Identifier
23929687
Citation
Damm 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 Reference
result
PubMed Identifier
26031472
Citation
Altundag 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 Reference
result
PubMed Identifier
32253535
Citation
Lechien 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 Reference
result
PubMed Identifier
32541352
Citation
Wang 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.
Results Reference
result
Learn more about this trial
Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.
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