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

COVID-19 Pandemic Clinical Trial

Official title:

Effectiveness of a Physiotherapy Respiratory and Neurorehabilitation Treatment Protocol in Patients With COVID-19.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195099
• Other study ID #: 14/01/2022
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 17, 2022

Study information

• Verified date: January 2022
• Source: Universidad Católica de Ávila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 17, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Católica de Ávila	Ávila

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica de Ávila

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View Citation

Damm M, Pikart LK, Reimann H, Burkert S, Göktas Ö, Haxel B, Frey S, Charalampakis I, Beule A, Renner B, Hummel T, Hüttenbrink KB. Olfactory training is helpful in postinfectious olfactory loss: a randomized, controlled, multicenter study. Laryngoscope. 20 — View 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, S — View 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 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Primary	smell and taste	smell and taste questionnaire, maximum score (maximum capacity) 40 points. 0 minimum	1 week