NCT05195099

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
Last Updated

June 29, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 14, 2022

Last Update Submit

June 23, 2022

Conditions

Keywords

coronavirusphysiotherapies techniquesphysiotherapies specialtyagnosia for tastebreathing exercises

Outcome Measures

Primary Outcomes (2)

  • 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

  • smell and taste

    smell and taste questionnaire, maximum score (maximum capacity) 40 points. 0 minimum

    1 week

Study Arms (2)

control group

ACTIVE COMPARATOR
Other: respiratory treatment

respiratory treatment

EXPERIMENTAL
Other: respiratory treatment

Interventions

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.

control grouprespiratory treatment

Eligibility Criteria

Age18 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Under 18 years old.
  • Over 42 years old.
  • Patients not diagnosed with Covid-19 (PCR positive).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (7)

  • 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.

  • 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.

  • Sanchez Mila Z, Rodriguez Sanz D, Martin Nieto A, Jimenez Lobo A, Ramos Hernandez M, Campon Chekroun A, Frutos Llanes R, Barragan Casas JM, Velazquez Saornil J. Effects of a respiratory and neurological rehabilitation treatment plan in post Covid-19 affected university students. Randomized clinical study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241255967. doi: 10.1177/14799731241255967.

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsAgnosia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 18, 2022

Study Start

February 1, 2022

Primary Completion

May 1, 2022

Study Completion

June 17, 2022

Last Updated

June 29, 2022

Record last verified: 2022-01

Locations