Effects of Cardiopulmonary Rehabilitation on Patients With POS-COVID Syndrome 19.

Sponsor

Centro Universitário Augusto Motta (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05402007

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

COVID-19 is an emerging pandemic disease caused by severe acute respiratory syndrome (SARS-CoV-2). Although most patients infected with SARS-CoV-2 are asymptomatic or have mild symptoms, some patients develop severe symptoms that can long-term impair their quality of life and functional capacity. SARS-CoV-2 is closely related to severe acute respiratory syndrome (SARS) with direct and indirect effects on several systems, especially the musculoskeletal system, in addition to the respiratory system. Some of these symptoms persist for a long time, called Post-Covid-19 Syndrome, directly interfering with the functional capacity and quality of life of these patients. Cardiopulmonary Rehabilitation exercises focus on restoring functional capacity with lung diseases. The main objective of this study is to evaluate the clinical and functional effects of a quarterly cardiopulmonary rehabilitation exercise program for patients with post-COVID syndrome.

The secondary objectives of the study presented are to evaluate the effects of Cardiopulmonary Rehabilitation exercises on muscle strength and peripheral endurance, to compare the effects of Cardiopulmonary Rehabilitation on fatigue and dyspnea levels in patients with post-COVID syndrome, correlating the effects of Cardiopulmonary Rehabilitation on peripheral muscle function and symptoms of fatigue and dyspnea in patients with post-COVID syndrome, and tovalue the effects of Cardiopulmonary Rehabilitation on the quality of life of patients with post-COVID syndrome.

Condition or Disease	Intervention/Treatment	Phase
Post- COVID-19 Syndrome Exercises Pulmonary Rehabilitation COVID-19 Randomized Clinical Trial	Other: Pulmonary rehabilitation exercises at the Rehabilitation Center Other: Home Intervention	N/A

Detailed Description

This is a randomized, controlled, double-blind treatment trial with a 1:1 allocation ratio.

Participants: Patients will be recruited at the Central Hospital of the Military Police and in the specialized multidisciplinary follow-up outpatient clinic after COVID-19. The participants will be adults (≥18 years), with a previous diagnosis COVID-19, who required hospitalization and need for invasive mechanical ventilation for at least 7 days and who were discharged from the hospital between August and Dec 2021.

Intervention and comparison:

This study will be divided into three groups: control group, face-to-face intervention group and home intervention group. Both groups will be evaluated before and after the study period, however the control group will only receive the treatment offered to the other groups after the end of the study. Physical functions and functional capacity will be evaluated.

After ensuring that patients meet the inclusion criteria, they will be divided into groups that will receive supervised care in a supervised Pulmonary Rehabilitation Center, with protocoled exercises, the other group will receive a booklet of self-explanatory exercises for performing the exercises in home, and the control group that will not receive intervention in this period.

The intervention groups should perform the exercises in the period of 12 weeks, 2 times a week, totaling 24 intervention sessions.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Three pre-post assessment groups (control/face-to-face intervention/self-performed home intervention)Three pre-post assessment groups (control/face-to-face intervention/self-performed home intervention)

Masking:

Single (Investigator)

Masking Description:

The study will be a clinical trial previously randomized by electronic randomization system (www.random.org) and the allocation of volunteers in the study arms will be done without the participation of the researchers. The study will be double-blind since neither the volunteers nor the professional who will perform the Cardiopulmonary Rehabilitation protocol is aware of the objectives and clinical valences that will be measured by the study.

Primary Purpose:

Treatment

Official Title:

Effects of Cardiopulmonary Rehabilitation on Peripheral Muscle Strength, Dyspnea and Fatigue of Patients With POS-COVID Syndrome 19: Randomized Controlled Clinical Trial.

Anticipated Study Start Date :

Jul 30, 2022

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control The control group will not receive intervention during the study.
Active Comparator: Face-to-face intervention The face-to-face intervention group will perform pulmonary rehabilitation at the professional-oriented Rehabilitation Center.	Other: Pulmonary rehabilitation exercises at the Rehabilitation Center Face-to-face intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will prescribe pulmonary rehabilitation exercises that will be performed at the pulmonary rehabilitation center.
Active Comparator: Home intervention The home intervention group will carry out home intervention through a self-explanatory exercise booklet.	Other: Home Intervention Home Intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will provide a portfolio of self-explanatory exercises, and guide participants on safety precautions.

Arm

Intervention/Treatment

No Intervention: Control

The control group will not receive intervention during the study.

Active Comparator: Face-to-face intervention

The face-to-face intervention group will perform pulmonary rehabilitation at the professional-oriented Rehabilitation Center.

Other: Pulmonary rehabilitation exercises at the Rehabilitation Center

Face-to-face intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will prescribe pulmonary rehabilitation exercises that will be performed at the pulmonary rehabilitation center.

Active Comparator: Home intervention

The home intervention group will carry out home intervention through a self-explanatory exercise booklet.

Other: Home Intervention

Home Intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will provide a portfolio of self-explanatory exercises, and guide participants on safety precautions.

Outcome Measures

Primary Outcome Measures

Peripheral muscle function I [12 weeks]
Will be assessed using the Palm Grip Dynamometry
Peripheral muscle function II [12 weeks]
Will be assessed using the Quadriceps Peak Load Test
Peripheral muscle function III [12 weeks]
Will be assessed using the Quadriceps Muscle Endurance Test.
Daily living activity [12 weeks]
It will be evaluated by the modified Medical Resource Council (mMRC) dyspnea scale

Secondary Outcome Measures

Quality of life improvement [12 weeks]
The assessment of quality of life will be carried out using a generic instrument of 36 items, validated in Brazil and called the SF-36 (Short Form Health Survey).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients previously diagnosed with COVID-19, who required hospitalization and required invasive mechanical ventilation for at least 7 days and who were discharged between August and December 2021 to minimize regression to mean;
Both sexes;
Over 18 years of age.

Exclusion Criteria:

Need for supplemental home oxygen;
Motor or neurological or cognitive alteration that contraindicates the participation in the cardiopulmonary rehabilitation program.
Persistence of clinical signs of deep vein thrombosis