search
Back to results

Characteristics in Post Covid-19 Patients

Primary Purpose

Coronavirus Infection

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring Rehabilitation, Coronavirus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • With confirmed diagnosis for SARS-COV-2.

Exclusion Criteria:

  • With any type of simultaneous pneumopathy.
  • Patients with autoimmune disease
  • People with simultaneous infectious diseases
  • Pregnant women
  • With degenerative diseases of the nervous system or musculoskeletal system

Sites / Locations

  • Universidade do Estado do ParáRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

The exercises performed will attend the musculoskeletal dimension of the body, which includes the muscular strength / endurance indexes, which is part of the functional-motor dimension of physical fitness related to health. The protocol will be applied in the form of sessions lasting approximately 50 minutes, performed three times a week on alternate days, for a period of 6 weeks, totaling 20 sessions. For aerobic exercises, a treadmill will be used and for anaerobic exercises, four exercises involving muscle mobility / strength in upper and lower limbs will be performed at weight training station.

Outcomes

Primary Outcome Measures

Characteristics of lung
In the supine position, the patient will perform deep inspiration followed by momentary apnea inside the high resolution scanner to capture cross-sectional images of the chest with smaller cuts than 1mm of collimation which helped in the detection of even small lesions.
Respiratory muscle strength
Respiratory muscle strength will be assessed using the digital manovacuometer. The measurement will be performed as follows the patient will be asked to empty the lungs to the residual volume and then perform an inhalation until the total lung capacity.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
August 13, 2020
Sponsor
Universidade Metodista de Piracicaba
search

1. Study Identification

Unique Protocol Identification Number
NCT04514705
Brief Title
Characteristics in Post Covid-19 Patients
Official Title
Clinical Respiratory Investigation in Post Covid-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitation protocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to be conducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging and blood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later (T3). Expected results: a) clinical, image and transcriptome changes; b) clinical-functional improvement after CPRP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
Keywords
Rehabilitation, Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Exercise
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The exercises performed will attend the musculoskeletal dimension of the body, which includes the muscular strength / endurance indexes, which is part of the functional-motor dimension of physical fitness related to health. The protocol will be applied in the form of sessions lasting approximately 50 minutes, performed three times a week on alternate days, for a period of 6 weeks, totaling 20 sessions. For aerobic exercises, a treadmill will be used and for anaerobic exercises, four exercises involving muscle mobility / strength in upper and lower limbs will be performed at weight training station.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise with treadmil and weight training station
Primary Outcome Measure Information:
Title
Characteristics of lung
Description
In the supine position, the patient will perform deep inspiration followed by momentary apnea inside the high resolution scanner to capture cross-sectional images of the chest with smaller cuts than 1mm of collimation which helped in the detection of even small lesions.
Time Frame
post treatment in 3 days
Title
Respiratory muscle strength
Description
Respiratory muscle strength will be assessed using the digital manovacuometer. The measurement will be performed as follows the patient will be asked to empty the lungs to the residual volume and then perform an inhalation until the total lung capacity.
Time Frame
post treatment in 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: With confirmed diagnosis for SARS-COV-2. Exclusion Criteria: With any type of simultaneous pneumopathy. Patients with autoimmune disease People with simultaneous infectious diseases Pregnant women With degenerative diseases of the nervous system or musculoskeletal system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luiz F Falcão, PhD
Phone
+559198237-9488
Email
fabiofalcao29@yahoo.com.br
Facility Information:
Facility Name
Universidade do Estado do Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66055-490
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo S Rocha, Phd
Phone
91992340234
Email
fisiorocha2000@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32766458
Citation
Kamalakannan S, Chakraborty S. Occupational therapy: The key to unlocking locked-up occupations during the COVID-19 pandemic. Wellcome Open Res. 2020 Jul 1;5:153. doi: 10.12688/wellcomeopenres.16089.1. eCollection 2020.
Results Reference
result
PubMed Identifier
32759457
Citation
Torlinski T, Rakasz L, Wysota B, Czyz M, Snelson C. An interdisciplinary approach to the management of critically ill patients during covid-19 pandemic; an experience of a university hospital in England. Wiad Lek. 2020;73(7):1576-1579.
Results Reference
result
PubMed Identifier
32737507
Citation
Rooney S, Webster A, Paul L. Systematic Review of Changes and Recovery in Physical Function and Fitness After Severe Acute Respiratory Syndrome-Related Coronavirus Infection: Implications for COVID-19 Rehabilitation. Phys Ther. 2020 Sep 28;100(10):1717-1729. doi: 10.1093/ptj/pzaa129.
Results Reference
result
PubMed Identifier
32732744
Citation
Saeki T, Ogawa F, Chiba R, Nonogaki M, Uesugi J, Takeuchi I, Nakamura T. Rehabilitation Therapy for a COVID-19 Patient Who Received Mechanical Ventilation in Japan. Am J Phys Med Rehabil. 2020 Oct;99(10):873-875. doi: 10.1097/PHM.0000000000001545.
Results Reference
result
PubMed Identifier
32723665
Citation
Grigoletto I, Cavalheri V, Lima FF, Ramos EMC. Recovery after COVID-19: The potential role of pulmonary rehabilitation. Braz J Phys Ther. 2020 Nov-Dec;24(6):463-464. doi: 10.1016/j.bjpt.2020.07.002. Epub 2020 Jul 19. No abstract available.
Results Reference
result
PubMed Identifier
32723204
Citation
Abdullahi A, Bello B, Mukhtar NB, Kaka B, Abba MA, Usman JS, Shittu A, Mayana KI, Maiwada SA, Mohammed J. Physiotherapy management of COVID-19 in Africa: Ongoing efforts, challenges, and future directions. Physiother Theory Pract. 2020 Aug;36(8):871-872. doi: 10.1080/09593985.2020.1798163. Epub 2020 Jul 29. No abstract available.
Results Reference
result

Learn more about this trial

Characteristics in Post Covid-19 Patients

We'll reach out to this number within 24 hrs