Gender Differences in the Recovery Rate Following PR in Patients With Long COVID-19

NCT05736939 | Completed

• 1 other identifier: 24633
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective analysis is to compare the magnitude of improvement in respiratory and peripheral muscle strength, following the completion of a hybrid pulmonary rehabilitation programme, in men and women with long COVID-19 syndrome. The main question it aims to answer is the following: • does gender limits the effects of a hybrid pulmonary rehabilitation programme on respiratory and peripheral muscle strength?

Conditions

Post Acute COVID-19 Syndrome

Keywords

Post-Acute COVID-19 Syndrome; Pulmonary Rehabilitation; Muscle strength; Quality of life

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Degree of fatigue will be assessed via the Functional Assessment of Chronic Illness Therapy questionnaire

  Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)

Secondary Outcomes (14)

• Quadriceps muscle strength

  Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)

• Handgrip muscle strength

  Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)

• Inspiratory muscle strength

  Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)

• Expiratory muscle strength

  Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)

• Dyspnoea

  Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)

Study Arms (2)

Men with long COVID-19 syndrome

Patients were male adults (\>18 years), with persistent symptoms more than 3 months since the acute phase of the COVID-19.

Other: Out-patient Pulmonary Rehabilitation

Women with long COVID-19 syndrome

Patients were women adults (\>18 years), with persistent symptoms more than 3 months since the acute phase of the COVID-19.

Other: Out-patient Pulmonary Rehabilitation

Interventions

Out-patient Pulmonary Rehabilitation OTHER

Pulmonary Rehabilitation (PR) programme consisting of 30 minutes interval aerobic exercise on cycle ergometers at 100% of peak work rate (WRpeak) and resistance exercises for the upper body. Dyspnoea and leg discomfort were recorded on the modified 1-10 Borg scale, whereas heart rate (HR) and oxygen saturation (SpO2%) were monitored by a pulse oximeter. Based on symptoms of breathlessness and fatigue reported at the end of each session, the exercise intensity was increased by 5-10% of the baseline WRpeak in the next session. The remote 24 home-based PR sessions consisted of 30 minutes walking with an individualised target of steps, recorded via the mobile app installed in the patients' mobile phone. The steps, leg discomfort and dyspnoea were reported by the patient via a physical activity diary on a weekly basis. If dyspnoea and fatigue were both \<4 at the Borg scale the weekly target of steps was increased by 5-10% by the assessors.

Men with long COVID-19 syndrome; Women with long COVID-19 syndrome

Eligibility Criteria

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

Study Population

Τhe study population consists of patients who have been diagnosed with long COVID-19 based on the persistence of fatigue at least three months following hospital discharge due to COVID-19. All patients participated in a pulmonary rehabilitation programme which is provided in these patients by our clinic.

You may qualify if:

• Hospitalisation due to Sars-COV-2 infection.
• Presence of persistence fatigue assessed via FACIT questionnaire.

You may not qualify if:

• participation in another clinical trial
• occurrence of myocardial infarction
• hospitalisation for unstable angina
• stroke
• coronary artery bypass graft (CABG)
• percutaneous coronary intervention (PCI)
• implantation of a cardiac resynchronisation therapy device (CRTD)
• active treatment for cancer or other malignant disease
• uncontrolled congestive heart disease (NYHA class \>3)
• acute psychosis or major psychiatric disorders or continued substance abuse

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Sotiria Hospital

Athens, Greece

Location

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Related Links

• Coronavirus cases
• Coronavirus cases

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikolaos Chynkiamis, Ph.D.

  Sotiria General Hospital for Chest Diseases, Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Exercise Physiologist

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: February 21, 2023
• Study Start: October 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 15, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)