Skip to content

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

Gender Differences in the Recovery Rate Following a Hybrid Pulmonary Rehabilitation Programme in Patients With Long COVID-19 Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05736939
Enrollment
30
Registered
2023-02-21
Start date
2022-10-01
Completion date
2023-03-15
Last updated
2023-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Acute COVID-19 Syndrome

Keywords

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

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?

Detailed description

As of January 2023, more than 500 million people have been affected by Severe Acute Respiratory Distress Syndrome-Coronavirus-2 (SARS-COV-2) globally. In Greece, since January 2020 there have been more than 5 million confirmed cases of COVID-19 and more than 35,000 deaths. Based on this data, it seems that the majority of patients recover (even those requiring hospital admission) but present with persistent symptoms at least three months after the acute illness, a condition defined as 'Long COVID-19'. The most commonly reported symptoms include long-standing fatigue, dyspnoea, muscle and joint pain, sleep disturbances, short-term memory loss and brain fog. This syndrome affects a large group of patients, and according to World Health Organisation it imposes a great burden on the healthcare systems worldwide. Consequently, it is important to identify preventable risk factors for 'Long COVID-19' in order to address the complex needs of these patients and reduce the prevalence of this new long-term condition. According to the Post-hospitalisation COVID-19 study (PHOSP-COVID) which has included adults with COVID-19 discharged from United Kingdom hospitals, the main risk factors associated with worse recovery at 1 year involved obesity, need for invasive mechanical ventilation during the acute illness and female sex. Other studies evaluating the prevalence of 'Long COVID-19' in the two sexes found that female patients were more likely to have one or more symptoms 12 months following the acute phase of the disease. Despite the fact that lengths of hospital and ICU stay were reduced in women compared to men, female sex proved to be an independent risk factor for the development of ongoing symptoms, among which were fatigue, dyspnoea, muscle aches and generalised weakness. The autoimmune hypothesis could account for the higher incidence of 'Long COVID-19' syndrome in women. According to this hypothesis, the immune response for both genetic and hormonal factors is stronger in women compared to men and hence autoimmune reactions are more prevalent in women. Guidelines have been published suggesting the implementation of pulmonary rehabilitation (PR) programmes for the management of patients with 'Long COVID-19' syndrome. According to recently published systematic reviews, pulmonary rehabilitation is beneficial for patients with long COVID-19 syndrome in terms of quality of life, muscle strength, walking capacity and sit-to-stand performance. Whether reduced recovery prognosis and long-lasting ongoing symptoms in women adversely affect the outcome of rehabilitation is still unknown. This is an important issue for healthcare systems when considering management strategies for people with 'Long COVID-19' syndrome. Furthermore, tele-rehabilitation programmes are feasible and effective in improving physical capacity, quality of life and symptoms in adult survivors of COVID-19. Accordingly, the present study looked into the effect of a hybrid rehabilitation programme (including out-patient and home-based sessions) on physical and mental health outcomes in previously hospitalised women and men with 'Long COVID-19' syndrome. It was hypothesised that the magnitude of improvement in women would be less compared to men.

Interventions

OTHEROut-patient Pulmonary Rehabilitation

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.

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
FatiguePrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Degree of fatigue will be assessed via the Functional Assessment of Chronic Illness Therapy questionnaire

Secondary

MeasureTime frameDescription
Handgrip muscle strengthPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Handgrip muscle strength will be reported as maximum strength in kg
Inspiratory muscle strengthPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Inspiratory muscle strength will be reported as maximum strength in centimeters water
Expiratory muscle strengthPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Expiratory muscle strength will be reported as maximum strength in centimeters water
DyspnoeaPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Dyspnoea will be assessed via completion of modified Medical Research Council Dyspnoea Scale questionnaire. The score ranges from 0-4. The greater the score, the worse the dyspnoea levels
Emotional statusPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Emotional status will be assessed via completion of the Hospital Anxiety and Depression. Scale questionnaire. The score ranges from 0-21 for each component (anxiety and depression). The higher the score, the higher the levels of anxiety and depression.
SymptomsPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Symptoms will be assessed via completion of the Chronic Obstructive Pulmonary Disease Assessment Tool questionnaire. The score ranges from 0-40 points. The higher the score, the worse the prognosis.
Quadriceps muscle strengthPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Quadriceps muscle strength will be reported as maximum strength in kg
Post traumatic stress disorder (PTSD)Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)PTSD will be assessed via completion of the Impact Event Scale-Revised questionnaire.The total score ranges from 0-88. The higher the score, the higher the levels of PTSD
Six minute walk distance coveredPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)The distance that patients cover during the six minute walk test.
Short Physical Performance Buttery test (SPPB)Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)SPPB is a series of test including balance, 4 meter walk and 5 sit-to-stand repetitions. The test assess the functional capacity of the patients.
Level of daily physical activityPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Level of daily physical activity will be reported as steps per day the week prior the initiation of the intervention and one week following the completion of the intervention.
Exercise tolerancePrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Exercise tolerance will be assessed by performing a cardiopulmonary exercise test.
Cardiac functionPrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Cardiac function will be assessed via a resting echocardiography
Self-reported quality of lifePrior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)Self-reported quality of life will be assessed via completion of the EuroQol-5Dimension-5Levels questionnaire.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026