Effects of Cardiopulmonary Rehabilitation in Participants With Post-COVID 19 Syndrome.
Condition: Post- COVID-19 Syndrome; Exercises; Pulmonary Rehabilitation; COVID-19; Randomized Clinical Trial
MeSH terms: COVID-19; Syndrome
Study type: Interventional

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.
    

Intervention name(s): Pulmonary rehabilitation exercises at the Rehabilitation Center; Home Intervention
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three pre-post assessment groups (control/face-to-face intervention/self-performed home intervention)
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: COVID-19; Post- COVID-19 syndrome; Pulmonary Rehabilitation; Exercises