- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05195099
Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ávila, Spain, 05005
- Universidad Católica de Ávila
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
|
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.
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Experimental: respiratory treatment
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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1 year
|
smell and taste
Time Frame: 1 week
|
smell and taste questionnaire, maximum score (maximum capacity) 40 points.
0 minimum
|
1 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/01/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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