Effects of Cardiopulmonary Rehabilitation in Participants With Post-COVID 19 Syndrome.

COVID-19 Clinical Trial

Official title:

Clinical and Functional Effects of Supervised and Unsupervised Cardiopulmonary Rehabilitation in POST-COVID-19 Syndrome: Clinical and Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05402007
• Other study ID #: NTC20457
• Status: Completed
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: July 2023
• Source: Centro Universitário Augusto Motta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Exercises
• Pulmonary Rehabilitation
• Randomized Clinical Trial
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Centro de Fisiatria e Reabilitação da Polícia Militar- RJ	Rio De Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral muscle function I	Will be assessed using the Palm Grip Dynamometry	12 weeks
Primary	Peripheral muscle function II	Will be assessed using the Quadriceps Peak Load Test	12 weeks
Primary	Peripheral muscle function III	Will be assessed using the Quadriceps Muscle Endurance Test.	12 weeks
Primary	Daily living activity	It will be evaluated by the modified Medical Resource Council (mMRC) dyspnea scale	12 weeks
Secondary	Quality of life improvement	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).	12 weeks