Post Acute COVID-19 SyndromeNCT05736939
Gender Differences in the Recovery Rate Following PR in Patients With Long COVID-19
An observational study of Post Acute COVID-19 Syndrome, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Acute COVID-19 Syndrome
- What is being tested?
- Out-patient Pulmonary Rehabilitation
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2022to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Hospitalisation due to Sars-COV-2 infection.
- Presence of persistence fatigue assessed via FACIT questionnaire.
Who cannot join
- Exclusion criteria include presence of any of the following list within 3 months prior to informed consent:
- participation in another clinical trial
- occurrence of myocardial infarction
- hospitalisation for unstable angina
- stroke
- coronary artery bypass graft (CABG)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender Differences in the Recovery Rate Following a Hybrid Pulmonary Rehabilitation Programme in Patients With Long COVID-19 Syndrome
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?
Read the 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.
- Conditions
- Post Acute COVID-19 Syndrome
- Being tested
- Out-patient Pulmonary Rehabilitation
- Keywords
- Post-Acute COVID-19 Syndrome, Pulmonary Rehabilitation, Muscle strength, Quality of life
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Out-patient Pulmonary RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Out-patient Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Degree of fatigue will be assessed via the Functional Assessment of Chronic Illness Therapy questionnaire
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Secondary outcomes (14)
Quadriceps muscle strength
Quadriceps muscle strength will be reported as maximum strength in kg
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Handgrip muscle strength
Handgrip muscle strength will be reported as maximum strength in kg
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Inspiratory muscle strength
Inspiratory muscle strength will be reported as maximum strength in centimeters water
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Expiratory muscle strength
Expiratory muscle strength will be reported as maximum strength in centimeters water
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Dyspnoea
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
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Emotional status
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.
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Symptoms
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.
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Self-reported quality of life
Self-reported quality of life will be assessed via completion of the EuroQol-5Dimension-5Levels questionnaire.
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Post traumatic stress disorder (PTSD)
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
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Six minute walk distance covered
The distance that patients cover during the six minute walk test.
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Short Physical Performance Buttery test (SPPB)
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.
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Level of daily physical activity
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.
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Exercise tolerance
Exercise tolerance will be assessed by performing a cardiopulmonary exercise test.
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Cardiac function
Cardiac function will be assessed via a resting echocardiography
Measured: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Oct 2022
- Primary completion28 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Post Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Chynkiamis, National and Kapodistrian University of Athens
- Investigators
- Nikolaos Chynkiamis, Ph.D., Principal investigator, Sotiria General Hospital for Chest Diseases, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736939
- Sponsor's protocol ID
- 24633
- Status last verified
- Oct 2023
- First submitted
- 19 Feb 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared to any other research team. The data that will be collected retrospectively for the present study as the patients have already completed the pulmonary rehabilitation programme. The rehabilitation department of our clinic is responsible for the storage and the management of patients data. In that content, they will share with the research team the necessary data to complete our study. The research team is not authorised to share the data with other research teams or researchers.
Publications
Goertz YMJ, Van Herck M, Delbressine JM, Vaes AW, Meys R, Machado FVC, Houben-Wilke S, Burtin C, Posthuma R, Franssen FME, van Loon N, Hajian B, Spies Y, Vijlbrief H, van 't Hul AJ, Janssen DJA, Spruit MA. Persistent symptoms 3 months after a SARS-CoV-2 infection: the post-COVID-19 syndrome? ERJ Open Res. 2020 Oct 26;6(4):00542-2020. doi: 10.1183/23120541.00542-2020. eCollection 2020 Oct.
PubMed 33257910Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Evans RA, McAuley H, Harrison EM, Shikotra A, Singapuri A, Sereno M, Elneima O, Docherty AB, Lone NI, Leavy OC, Daines L, Baillie JK, Brown JS, Chalder T, De Soyza A, Diar Bakerly N, Easom N, Geddes JR, Greening NJ, Hart N, Heaney LG, Heller S, Howard L, Hurst JR, Jacob J, Jenkins RG, Jolley C, Kerr S, Kon OM, Lewis K, Lord JM, McCann GP, Neubauer S, Openshaw PJM, Parekh D, Pfeffer P, Rahman NM, Raman B, Richardson M, Rowland M, Semple MG, Shah AM, Singh SJ, Sheikh A, Thomas D, Toshner M, Chalmers JD, Ho LP, Horsley A, Marks M, Poinasamy K, Wain LV, Brightling CE; PHOSP-COVID Collaborative Group. Physical, cognitive, and mental health impacts of COVID-19 after hospitalisation (PHOSP-COVID): a UK multicentre, prospective cohort study. Lancet Respir Med. 2021 Nov;9(11):1275-1287. doi: 10.1016/S2213-2600(21)00383-0. Epub 2021 Oct 7.
PubMed 34627560PHOSP-COVID Collaborative Group. Clinical characteristics with inflammation profiling of long COVID and association with 1-year recovery following hospitalisation in the UK: a prospective observational study. Lancet Respir Med. 2022 Aug;10(8):761-775. doi: 10.1016/S2213-2600(22)00127-8. Epub 2022 Apr 23.
PubMed 35472304Wynberg E, van Willigen HDG, Dijkstra M, Boyd A, Kootstra NA, van den Aardweg JG, van Gils MJ, Matser A, de Wit MR, Leenstra T, de Bree G, de Jong MD, Prins M; RECoVERED Study Group. Evolution of Coronavirus Disease 2019 (COVID-19) Symptoms During the First 12 Months After Illness Onset. Clin Infect Dis. 2022 Aug 24;75(1):e482-e490. doi: 10.1093/cid/ciab759.
PubMed 34473245Thompson EJ, Williams DM, Walker AJ, Mitchell RE, Niedzwiedz CL, Yang TC, Huggins CF, Kwong ASF, Silverwood RJ, Di Gessa G, Bowyer RCE, Northstone K, Hou B, Green MJ, Dodgeon B, Doores KJ, Duncan EL, Williams FMK; OpenSAFELY Collaborative; Steptoe A, Porteous DJ, McEachan RRC, Tomlinson L, Goldacre B, Patalay P, Ploubidis GB, Katikireddi SV, Tilling K, Rentsch CT, Timpson NJ, Chaturvedi N, Steves CJ. Long COVID burden and risk factors in 10 UK longitudinal studies and electronic health records. Nat Commun. 2022 Jun 28;13(1):3528. doi: 10.1038/s41467-022-30836-0.
PubMed 35764621Boscolo-Rizzo P, Guida F, Polesel J, Marcuzzo AV, Capriotti V, D'Alessandro A, Zanelli E, Marzolino R, Lazzarin C, Antonucci P, Sacchet E, Tofanelli M, Borsetto D, Gardenal N, Pengo M, Tirelli G. Sequelae in adults at 12 months after mild-to-moderate coronavirus disease 2019 (COVID-19). Int Forum Allergy Rhinol. 2021 Dec;11(12):1685-1688. doi: 10.1002/alr.22832. Epub 2021 Jun 9. No abstract available.
PubMed 34109765Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
PubMed 33692530Lindahl A, Aro M, Reijula J, Makela MJ, Ollgren J, Puolanne M, Jarvinen A, Vasankari T. Women report more symptoms and impaired quality of life: a survey of Finnish COVID-19 survivors. Infect Dis (Lond). 2022 Jan;54(1):53-62. doi: 10.1080/23744235.2021.1965210. Epub 2021 Aug 19.
PubMed 34410220Fernandez-de-Las-Penas C, Martin-Guerrero JD, Pellicer-Valero OJ, Navarro-Pardo E, Gomez-Mayordomo V, Cuadrado ML, Arias-Navalon JA, Cigaran-Mendez M, Hernandez-Barrera V, Arendt-Nielsen L. Female Sex Is a Risk Factor Associated with Long-Term Post-COVID Related-Symptoms but Not with COVID-19 Symptoms: The LONG-COVID-EXP-CM Multicenter Study. J Clin Med. 2022 Jan 14;11(2):413. doi: 10.3390/jcm11020413.
PubMed 35054108Brodin P. Immune determinants of COVID-19 disease presentation and severity. Nat Med. 2021 Jan;27(1):28-33. doi: 10.1038/s41591-020-01202-8. Epub 2021 Jan 13.
PubMed 33442016Spruit MA, Holland AE, Singh SJ, Tonia T, Wilson KC, Troosters T. COVID-19: interim guidance on rehabilitation in the hospital and post-hospital phase from a European Respiratory Society- and American Thoracic Society-coordinated international task force. Eur Respir J. 2020 Dec 3;56(6):2002197. doi: 10.1183/13993003.02197-2020. Print 2020 Dec.
PubMed 32817258Singh SJ, Barradell AC, Greening NJ, Bolton C, Jenkins G, Preston L, Hurst JR. British Thoracic Society survey of rehabilitation to support recovery of the post-COVID-19 population. BMJ Open. 2020 Dec 2;10(12):e040213. doi: 10.1136/bmjopen-2020-040213.
PubMed 33268418Fugazzaro S, Contri A, Esseroukh O, Kaleci S, Croci S, Massari M, Facciolongo NC, Besutti G, Iori M, Salvarani C, Costi S; Reggio Emilia COVID-19 Working Group. Rehabilitation Interventions for Post-Acute COVID-19 Syndrome: A Systematic Review. Int J Environ Res Public Health. 2022 Apr 24;19(9):5185. doi: 10.3390/ijerph19095185.
PubMed 35564579Spielmanns M, Buelow MM, Pekacka-Egli AM, Cecon M, Spielmanns S, Windisch W, Hermann M. Clinical and Functional Predictors of Response to a Comprehensive Pulmonary Rehabilitation in Severe Post-COVID-19 Patients. Microorganisms. 2021 Nov 28;9(12):2452. doi: 10.3390/microorganisms9122452.
PubMed 34946054
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in the Recovery Rate Following a Hybrid Pulmonary Rehabilitation Programme in Patients With Long COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT05736939
- Acronym / sponsor ID
- 24633
- Conditions
- Post Acute COVID-19 Syndrome
- Keywords
- Post-Acute COVID-19 Syndrome, Pulmonary Rehabilitation, Muscle strength, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men with long COVID-19 syndrome | – | Other: Out-patient Pulmonary RehabilitationPatients were male adults (>18 years), with persistent symptoms more than 3 months since the acute phase of the COVID-19. |
| Women with long COVID-19 syndrome | – | Other: Out-patient Pulmonary RehabilitationPatients were women adults (>18 years), with persistent symptoms more than 3 months since the acute phase of the COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Hospitalisation due to Sars-COV-2 infection.
- Presence of persistence fatigue assessed via FACIT questionnaire.
Key exclusion criteria (11 listed)
- Exclusion criteria include presence of any of the following list within 3 months prior to informed consent:
- participation in another clinical trial
- occurrence of myocardial infarction
- hospitalisation for unstable angina
- stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Out-patient Pulmonary RehabilitationPulmonary 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. | Other | Men with long COVID-19 syndrome, Women with long COVID-19 syndrome |
Primary outcome
Fatigue
Time frame: Prior 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
14 secondary outcomes
Quadriceps muscle strength
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Handgrip muscle strength
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Inspiratory muscle strength
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Expiratory muscle strength
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Dyspnoea
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Emotional status
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Symptoms
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Self-reported quality of life
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Post traumatic stress disorder (PTSD)
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Six minute walk distance covered
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Short Physical Performance Buttery test (SPPB)
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Level of daily physical activity
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Exercise tolerance
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Cardiac function
Time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Background: PubMed 33257910Goertz YMJ, Van Herck M, Delbressine JM, Vaes AW, Meys R, Machado FVC, Houben-Wilke S, Burtin C, Posthuma R, Franssen FME, van Loon N, Hajian B, Spies Y, Vijlbrief H, van 't Hul AJ, Janssen DJA, Spruit MA. Persistent symptoms 3 months after a SARS-CoV-2 infection: the post-COVID-19 syndrome? ERJ Open Res. 2020 Oct 26;6(4):00542-2020. doi: 10.1183/23120541.00542-2020. eCollection 2020 Oct.
- Background: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Background: PubMed 34627560Evans RA, McAuley H, Harrison EM, Shikotra A, Singapuri A, Sereno M, Elneima O, Docherty AB, Lone NI, Leavy OC, Daines L, Baillie JK, Brown JS, Chalder T, De Soyza A, Diar Bakerly N, Easom N, Geddes JR, Greening NJ, Hart N, Heaney LG, Heller S, Howard L, Hurst JR, Jacob J, Jenkins RG, Jolley C, Kerr S, Kon OM, Lewis K, Lord JM, McCann GP, Neubauer S, Openshaw PJM, Parekh D, Pfeffer P, Rahman NM, Raman B, Richardson M, Rowland M, Semple MG, Shah AM, Singh SJ, Sheikh A, Thomas D, Toshner M, Chalmers JD, Ho LP, Horsley A, Marks M, Poinasamy K, Wain LV, Brightling CE; PHOSP-COVID Collaborative Group. Physical, cognitive, and mental health impacts of COVID-19 after hospitalisation (PHOSP-COVID): a UK multicentre, prospective cohort study. Lancet Respir Med. 2021 Nov;9(11):1275-1287. doi: 10.1016/S2213-2600(21)00383-0. Epub 2021 Oct 7.
- Background: PubMed 35472304PHOSP-COVID Collaborative Group. Clinical characteristics with inflammation profiling of long COVID and association with 1-year recovery following hospitalisation in the UK: a prospective observational study. Lancet Respir Med. 2022 Aug;10(8):761-775. doi: 10.1016/S2213-2600(22)00127-8. Epub 2022 Apr 23.
- Background: PubMed 34473245Wynberg E, van Willigen HDG, Dijkstra M, Boyd A, Kootstra NA, van den Aardweg JG, van Gils MJ, Matser A, de Wit MR, Leenstra T, de Bree G, de Jong MD, Prins M; RECoVERED Study Group. Evolution of Coronavirus Disease 2019 (COVID-19) Symptoms During the First 12 Months After Illness Onset. Clin Infect Dis. 2022 Aug 24;75(1):e482-e490. doi: 10.1093/cid/ciab759.
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- Coronavirus casesLink provided by the sponsor.
- Coronavirus casesLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individual participant data will not be shared to any other research team. The data that will be collected retrospectively for the present study as the patients have already completed the pulmonary rehabilitation programme. The rehabilitation department of our clinic is responsible for the storage and the management of patients data. In that content, they will share with the research team the necessary data to complete our study. The research team is not authorised to share the data with other research teams or researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Chynkiamis, Ph.D. principal investigator
Sotiria General Hospital for Chest Diseases, Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Acute COVID-19 Syndrome, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Prior and following the completion of a 3 month pulmonary rehabilitation programme (At 0 and at 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05736939, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.