Characteristics in Post Covid-19 Patients

Sponsor

Universidade Metodista de Piracicaba (Other)

Overall Status

Unknown status

CT.gov ID

NCT04514705

Collaborator

(none)

Enrollment

Location

Arm

16.7

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection	Other: Exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

ExerciseExercise

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Respiratory Investigation in Post Covid-19 Patients

Actual Study Start Date :

Aug 11, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group 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.	Other: Exercise Exercise with treadmil and weight training station

Arm

Intervention/Treatment

Experimental: Intervention Group

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.

Other: Exercise

Exercise with treadmil and weight training station

Outcome Measures

Primary Outcome Measures

Characteristics of lung [post treatment in 3 days]
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 [post treatment in 3 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade do Estado do Pará	Belém	Pará	Brazil	66055-490

Sponsors and Collaborators

Universidade Metodista de Piracicaba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rodrigo Santiago Barbosa Rocha, Phd, Director of Human Movement Department, Universidade Metodista de Piracicaba

ClinicalTrials.gov Identifier:

NCT04514705

Other Study ID Numbers:

F110820

First Posted:

Aug 17, 2020

Last Update Posted:

Aug 17, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rodrigo Santiago Barbosa Rocha, Phd, Director of Human Movement Department, Universidade Metodista de Piracicaba

Rehabilitation

Coronavirus

Additional relevant MeSH terms:

Coronavirus Infections

Study Results

No Results Posted as of Aug 17, 2020