Pulmonary Rehabilitation of Patients With a History of COVID-19

NCT04751617 | Unknown

• 1 other identifier: Rehabilitation after COVID-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

SARS-CoV-2; Pulmonary rehabilitation; Quality of life; Body composition; Spirometry; Computed tomography; Morphology; Gasometry

Outcome Measures

Primary Outcomes (1)

• Change in the quality of life

  Comparison of the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire mean between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. The questionnaire consists of 26 questions. Answers are awarded a score in a five-point scale (1-5). Answer scores are calculated according to the WHOQOL-BREF algorithm in the range of 0-100 points. Higher score corresponds to higher quality of life.

  at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

Secondary Outcomes (10)

• Change in lung volume parameters (spirometry)

  at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

• Change in respiratory flow parameters (spirometry)

  at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

• Change in lung diffusing capacity

  at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

• Change in Body Mass Index (BMI)

  at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

• Change in the body composition (bioelectrical impedance analysis)

  at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

Study Arms (1)

Pulmonary rehabilitation (intervention)

EXPERIMENTAL

This group will be covered by pulmonary rehabilitation.

Procedure: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation 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.

Pulmonary rehabilitation (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów / Podkarpackie Center for Lung Diseases in Rzeszów

Rzeszów, 35-959, Poland

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 12, 2021
• Study Start: January 1, 2021
• Primary Completion: January 31, 2021
• Study Completion: March 31, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

PL (1)