Pulmonary Rehabilitation of Patients With a History of COVID-19

NCT ID: NCT04751617

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-03-31

Brief Summary

This study will determine the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of COVID-19.

Detailed Description

In December 2019, a novel coronavirus, SARS-CoV-2, appeared, causing a wide range of symptoms, mainly respiratory infection. In March 2020, the World Health Organization (WHO) declared Coronavirus Disease 2019 (COVID-19) a pandemic. COVID-19 has spread rapidly over several months, affecting patients across all age groups and geographic areas. The disease has a diverse course; patients may range from asymptomatic to those with respiratory failure, complicated by acute respiratory distress syndrome.

The main objective of this study is to assess the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of COVID-19.

The patients after COVID-19 will be included in the pulmonary rehabilitation protocol. The duration of rehabilitation will depend on the patient's condition: from 7 to 14 days.

Measurements:

• quality of life (WHOQoL-BREF)
• body composition (bioelectrical impedance analysis, BC-420 MA, Tanita)
• weight, height and BMI
• spirometry (Spirometr PNEUMO, abcMED)
• diffusion lung capacity for carbon monoxide (LUNGTEST 1000)
• morphology (CRP, D-Dimer, WBC) and gasometry (pCO2, pO2)
• chest computed tomography (CT).

These parameters will be recorded before the first day of rehabilitation (baseline), after completion of rehabilitation protocol, and three months after completion the rehabilitation protocol. A change in evaluated parameters will be assessed.

This will be a prospective, interventional, non-randomized study. All patients will be enrolled by Podkarpackie Center for Lung Diseases in Rzeszów.

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulmonary rehabilitation (intervention)

This group will be covered by pulmonary rehabilitation.

Group Type: EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type: PROCEDURE

Pulmonary rehabilitation will include: early mobilization with frequent posture changes and simple exercises in bed taking into account the patient's respiratory tract. Respiratory physiotherapy will also include improving diaphragm function along with training additional respiratory muscles. Active exercises of the upper limbs will be accompanied by gradual muscle strengthening. Aerobic regeneration will be carried out by walking along the hospital corridor, stationary bike and climbing stairs. Body balance therapy in closed systems in front of the mirror will also be included. After kinesiotherapy, the session will end with a vibration massage and relaxation of the whole body. Motivational breathing training will be used every 2 hours, 7 days a week, performed independently by the patient in the ward room. The physiotherapy process will be carried out 6 times a week and lasts 30-45 minutes a day. The duration of rehabilitation depends on the patient's condition: from 7 to 14 days.

Interventions

Pulmonary rehabilitation

Pulmonary rehabilitation will include: early mobilization with frequent posture changes and simple exercises in bed taking into account the patient's respiratory tract. Respiratory physiotherapy will also include improving diaphragm function along with training additional respiratory muscles. Active exercises of the upper limbs will be accompanied by gradual muscle strengthening. Aerobic regeneration will be carried out by walking along the hospital corridor, stationary bike and climbing stairs. Body balance therapy in closed systems in front of the mirror will also be included. After kinesiotherapy, the session will end with a vibration massage and relaxation of the whole body. Motivational breathing training will be used every 2 hours, 7 days a week, performed independently by the patient in the ward room. The physiotherapy process will be carried out 6 times a week and lasts 30-45 minutes a day. The duration of rehabilitation depends on the patient's condition: from 7 to 14 days.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male and female patients treated in Provincial Clinical Hospital No. 1 in Rzeszów/ Podkarpackie Center for Lung Diseases in Rzeszów,
• Patients with a history of COVID-19,
• Having obtained written informed consent (signed and dated) to participate in the study,
• Age at enrollment ≥ 18 years of age,
• No contraindications to pulmonary rehabilitation,
• No contraindications for body composition testing (bioelectrical impedance analysis).

Exclusion Criteria

• Refusal to participate in the study,
• Patients with any acute disease in the last 3 months before baseline,
• Patients currently enrolled in any clinical trial,
• Currently infected patients with COVID-19.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rzeszow

OTHER

Sponsor Role: lead

Responsible Party

Justyna Wyszyńska

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rzeszów / Podkarpackie Center for Lung Diseases in Rzeszów

Rzeszów, , Poland

Countries

Poland

Other Identifiers

Rehabilitation after COVID-19

Identifier Type: -

Identifier Source: org_study_id