Clinical trial NCT05402007: Effects of Cardiopulmonary Rehabilitation in Participants With Post-COVID 19 Syndrome.
Official title: Clinical and Functional Effects of Supervised and Unsupervised Cardiopulmonary Rehabilitation in POST-COVID-19 Syndrome: Clinical and Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post- COVID-19 Syndrome
Exercises
Pulmonary Rehabilitation
COVID-19
Randomized Clinical Trial
Keywords: COVID-19
Post- COVID-19 syndrome
Pulmonary Rehabilitation
Exercises
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three pre-post assessment groups (control/face-to-face intervention/self-performed home intervention)
Primary purpose: TREATMENT

Brief summary: COVID-19 is an emerging pandemic disease caused by severe acute respiratory syndrome (SARS-CoV-2). Although the majority of patients infected with SARS-CoV-2 are asymptomatic or have mild symptoms, some patients develop severe symptoms that can protractedly 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 period, called Post-Covid-19 Syndrome, directly interfering with the functional capacity and quality of life of these participants. Cardiopulmonary Rehabilitation exercises are focused on restoring functional capacity in patients affected by cardiopulmonary diseases. The primary objective of this study is to evaluate the clinical and functional effects of a quarterly Cardiopulmonary Rehabilitation exercise program for participants with post-COVID-19 syndrome.

The secondary objectives will be: To compare the effects of a supervised program of 12 weeks of supervised exercises and a program of self-performed home exercises, guided by an exercise booklet, of the same duration on muscle strength and peripheral resistance; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on levels of fatigue and dyspnea in patients with post-COVID-19 syndrome; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on health-related quality of life and post-COVID-19 functional status.

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 and ≤ 65 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.

Eligibility criteria: 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 old and under 65 years old.

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

Primary outcomes:
measure: Peripheral muscle function I
timeFrame: 12 weeks
measure: Peripheral muscle function II
timeFrame: 12 weeks
measure: Peripheral muscle function III
timeFrame: 12 weeks
measure: Daily living activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life improvement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Centro de Fisiatria e Reabilitação da Polícia Militar- RJ
state: RJ
Study officials:
affiliation: Centro Universitário Augusto Motta
name: Ana Carolina Sebastião da Silva
role: PRINCIPAL_INVESTIGATOR
References: