Clinical trial NCT04935437: Implementing a Rehabilitation Program in Patients Recovering From Covid-19 Infection
Official title: Implementing a Rehabilitation Program in Patients Recovering From Covid-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Keywords: Rehabilitation
post COVID-19 sequalae
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Before and after trial matched cohort trial.
Primary purpose: TREATMENT

Brief summary: Implementation of a supervised rehabilitation program in patients recovering from COVID-19-infection who suffer from limitations and symptoms due to the disease 6 to 8 weeks from hospital discharge. Patients who have been seriously ill and have been admitted to the ward with high oxygen mixtures or have been admitted to the ICU will be selected primarily. The program includes supervised rehabilitation sessions 2 times a week for 2 months. Patients will be evaluated during recruitment and at the end of the program. Patients who can not attend the program due to logistical/transport issues will be re-evaluated in 2 months and constitute the control population. Investigators hypothesis is that post COVID-19 patients who have persistent symptoms, including fatigue following a supervised rehabilitation program will have fewer symptoms after the end of the program compared to similar patients who do not attend a rehabilitation program.


Eligibility criteria: Inclusion Criteria: Candidates for inclusion in the study are:

* Patients recovering from COVID-19 disease AND suffering from persistent limitations (\>=1 month) of their physical activity and reduction of their quality of life and associated symptoms including shortness of breath, fatigue, weakness of the upper and lower extremities, post-traumatic stress, pain, etc.
* Priority will be given to patients suffering from more symptoms and disabilities. Patients who might suffer more after COVID-19 disease are:

  1. Patients admitted to the ICU, especially those who were intubated.
  2. Patients who needed high oxygen mixtures (high-flow nasal cannula -HFNC, non-re-breathing mask) as well as those who were older and had prolonged hospitalization.

     -

     Exclusion Criteria:
* Patients who suffer from active disease will not be included until they stop being infectious.
* Patients treated with COVID-19 infection where the main reason for hospitalization was not the virus infection (e.g. due to coronary heart disease, surgery, etc.) will also be excluded.
* Patients suffering from dementia,
* patients with myocarditis
* patients with thromboembolic disease that receive anticoagulants for less than a month
* patients chronically paralyzed,
* patients with paraplegia,
* patients with multiple injuries
* patients with serious orthopedic problems that cause disability
* patients suffering from very serious underlying diseases such as end-stage cancer,
* patients with neurological diseases that cause disability, require rehabilitation clinics and special interventions (speech therapy, kinesiotherapy, patients with tracheostomy etc.).

Primary outcomes:
measure: Assessment of fatigue with FACIT fatigue Scale
timeFrame: 2 months
measure: Assessment of fatigue using chalder fatigue scale.
timeFrame: 2 months
measure: Assessment of fatigue with Fatigue Severity Scale
timeFrame: 2 months
measure: Assessment of respiratory symptoms after COVID-19 with CAT.
timeFrame: 2 months
Secondary outcomes:
measure: Assessment of quality of life using SF-36 questionnaire.
timeFrame: 2 months
measure: Assessment of shortness of breath
timeFrame: 2 months
measure: Assessment of functional capacity with 6MWT.
timeFrame: 2 months
measure: Assessment of symptoms after COVID-19 with PCFS.
timeFrame: 2 months
measure: Assessment of lower extremity strength
timeFrame: 2 months.
measure: Assessment of functional capacity with one minute sit to stand test.
timeFrame: 2 months
measure: Assessment of functional capacity with Short Physical Performance Battery.
timeFrame: 2 months
measure: Assessment of Post Traumatic Stress Disorder with the Impact of Event Scale revised.
timeFrame: 2 months
measure: Assessment of anxiety and depression with HADS
timeFrame: 2 months
measure: Assessment of lung diffusion capacity.
timeFrame: 2 months
measure: Assessment of respiratory function with FVC
timeFrame: 2 months
measure: Assessment of quality of life using EQ-5D-5L questionnaire.
timeFrame: 2 months
measure: Assessment of physical activity with IPAQ.
timeFrame: 2 months
measure: Assessment of balance.
timeFrame: 2 months
measure: Assessment of respiratory function with FEV1
timeFrame: 2 months
measure: Assessment of cognitive dysfunction
timeFrame: 2 months
measure: Assessment of depression with Beck Depression Inventory
timeFrame: 2 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evangelismos Hospital
state: Attica
Study officials:
References:
citation: Spruit 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.
citation: Sally Singh, Charlotte Bolton, Claire Nolan, Theresa Harvey-Dunstan, Bronwen Connolly, William Man and Paul Walker. Delivering rehabilitation to patients surviving COVID-19 using an adapted pulmonary rehabilitation approach - BTS guidance [Internet]. British Thoracic Society; 2020. Available from: https://www.brit-thoracic.org.uk/document-library/quality-improvement/covid-19/pulmonary-rehabilitation-for-covid-19-patients/
citation: Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
citation: Daynes E, Gerlis C, Briggs-Price S, Jones P, Singh SJ. COPD assessment test for the evaluation of COVID-19 symptoms. Thorax. 2021 Feb;76(2):185-187. doi: 10.1136/thoraxjnl-2020-215916. Epub 2020 Nov 4.
citation: Klok FA, Boon GJAM, Barco S, Endres M, Geelhoed JJM, Knauss S, Rezek SA, Spruit MA, Vehreschild J, Siegerink B. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19. Eur Respir J. 2020 Jul 2;56(1):2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul.