COVID-19 Pneumonia: Pulmonary Physiology, Health-related Quality of Life and Benefit of a Rehabilitation Program

NCT04881214 | Unknown DMC

• 1 other identifier: 2020-001457
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The pathophysiological processes involved in COVID-19 pneumonia are not fully understood. Specific alterations of the airways, lung parenchyma and pulmonary vascular tree could explain a severe ventilation/perfusion heterogeneity resulting in severe hypoxemia during the active phase of the disease. Additional skeletal muscle impairment related to systemic inflammation may also explain persisting symptoms in the follow-up phase. The first aim of the present project is to explore these different processes by evaluating the impact of the COVID-19 pneumonia on exercise capacity, pulmonary function and perfusion by a physiological and radiologic study. An ambulatory pulmonary rehabilitation will also be studied to assess its impact on the physiological parameter mentioned and the health-related quality of life questionnaire as a potential long-term treatment. The investigators propose a single center randomized controlled study at the University Hospitals of Geneva. 60 adult patients having suffered a hypoxemic COVID-19 pneumonia with persistent symptoms at 3-months after hospital discharge will be included. A functional and physiological study will be performed, including a six-minute walk test, pulmonary function testing, diffusing capacity for carbon monoxide, maximal inspiratory pressure and sniff nasal inspiratory pressure. Those with at least one abnormal value will be invited to fill the Saint Georges Respiratory Questionnaire, the Short Form 36 and the Hospital Anxiety and Depression Scale and will undergo a chest dual energy computed tomography (DECT), a cardiopulmonary exercise testing with non-invasive cardiac output and stroke volume evaluation and an evaluation of the pulmonary shunt by hyperoxia (100% oxygen breathing) at rest and during light effort. Then patients will be randomized on a 1:1 basis for pulmonary rehabilitation program or usual care. All work-up except DECT will be repeated at 6 and 12 months after hospital discharge. The investigators hypothesize that our study will allow a better understanding of pathophysiological mechanisms involved in COVID-19. This will potentially determine therapeutic target for patients with persisting symptoms and functional decay after COVID-19. The investigators also expect to see an improvement of exercise capacity and physiological parameters in the pulmonary rehabilitation group, as compared to the control group, suggesting pulmonary rehabilitation as a possible long-term treatment of this condition.

Conditions

Covid19 Pneumonia; Chronic Thromboembolic Pulmonary Hypertension; Myopathy; Restrictive Lung Disease

Keywords

COVID-19; cardiopulmonary rehabilitation; spirometry; thromboembolic disease; non-invasive cardiac output

Outcome Measures

Primary Outcomes (1)

• Effect of ambulatory pulmonary rehabilitation in health related quality of life

  St George's Respiratory questionnaire change (units). Scores range from 0 to 100, with higher scores indicating more limitations

  12 months

Secondary Outcomes (18)

• Long-term consequences of COVID-19 pneumonia on VEMS

  12 months

• Long-term consequences of COVID-19 pneumonia on Vital Capacity

  12 months

• Long-term consequences of COVID-19 pneumonia on Total Lung Capacity

  12 months

• Long-term consequences of COVID-19 pneumonia on diffusion capacity of CO

  12 months

• long-term consequences of COVID-19 pneumonia on Vital Capacity (VC)

  12 months

Study Arms (2)

Control

NO INTERVENTION

Patients in this arm will receive standard of care

Pulmonary Rehabilitation

EXPERIMENTAL

Patients will undergo a 12-weeks Pulmonary rehabilitation program. It will include 3 sessions of supervised exercise per week, as initially proposed on COPD patients. Patients will exercise on electromagnetically braked cycle ergometers for 45 min by alternating 30-s exercise intervals at 100% of peak-work rate estimated during the initial incremental test, with 30-s rest periods. Total workload will be increased (by 5%) on a weekly basis. Strength training of lower and upper limbs, will also be included.

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation OTHER

pulmonary rehabilitation for 12 weeks, 3 times a week. control will take place at 3, 6 and 12 months

Pulmonary Rehabilitation

Eligibility Criteria

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

Patients will be eligible for inclusion if they fulfil all the following criteria: * Patients aged ≥ 18 years. * Confirmed diagnosis of SARS-Cov-2 infection by nasal swab, other viral sample (i.e. sputum, bronchoalveolar lavage) or Chest imaging suggestive of SARS-CoV-2 pneumonia (Chest X-ray or CT-scan). * Requirement for oxygen supplementation. * Persistent respiratory symptoms (i.e. dyspnoea, cough) or asthenia. * Abnormal 6MWT at 3 months (distance \< 90% predicted or desaturation ≥ 3% or Borg \>5) and/or abnormal lung function as described by the international recommendations Patients will be excluded if they: * Already had existing severe and symptomatic pulmonary condition before COVID-19 pneumonia * Are unable to execute the different tests and surveys because of cognitive or physical limitations. * Are already included in a structured rehabilitation program * Have comorbidities with a life expectancy of less than 12 months. * Any relevant acute medical disorder/acute disease state judged by the investigators as likely to represent a risk for the patient to fulfil a rehabilitation program or requiring urgent investigations.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Ligue Pulmonaire Genevoise: collaborator

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location

Related Publications (5)

• Finegan O, Fonseca S, Guyomarc'h P, Morcillo Mendez MD, Rodriguez Gonzalez J, Tidball-Binz M, Winter KA; ICRC Advisory Group on the Management of COVID-19 Related Fatalities. International Committee of the Red Cross (ICRC): General guidance for the management of the dead related to COVID-19. Forensic Sci Int Synerg. 2020 Mar 31;2:129-137. doi: 10.1016/j.fsisyn.2020.03.007. eCollection 2020.

  PMID: 32412013 BACKGROUND

• Correction to Lancet Respir Med 2020; 8: 420-22. Lancet Respir Med. 2020 Apr;8(4):e26. doi: 10.1016/S2213-2600(20)30085-0. Epub 2020 Feb 25. No abstract available.

  PMID: 32109426 BACKGROUND

• Tian S, Hu W, Niu L, Liu H, Xu H, Xiao SY. Pulmonary Pathology of Early-Phase 2019 Novel Coronavirus (COVID-19) Pneumonia in Two Patients With Lung Cancer. J Thorac Oncol. 2020 May;15(5):700-704. doi: 10.1016/j.jtho.2020.02.010. Epub 2020 Feb 28.

  PMID: 32114094 BACKGROUND

• Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.

  PMID: 32325026 BACKGROUND

• Guerreiro I, Bringard A, Nehme M, Guessous I, Benzakour L, Juillet De Saint Lager-Lucas A, Taboni A, Lador F. Exercise ventilatory response after COVID-19: comparison between ambulatory and hospitalized patients. Am J Physiol Lung Cell Mol Physiol. 2023 Dec 1;325(6):L756-L764. doi: 10.1152/ajplung.00142.2023. Epub 2023 Oct 24.

  PMID: 37874657 DERIVED

MeSH Terms

Conditions

Muscular Diseases; COVID-19; Thromboembolism

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lador Frédéric, MD-PHD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: May 11, 2021
• Study Start: July 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)