Implementing a Rehabilitation Program in Patients Recovering From Covid-19 Infection

NCT ID: NCT04935437

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2022-02-26

Brief Summary

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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.

Detailed Description

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Conditions

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Rehabilitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Before and after trial matched cohort trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

The patients in this arm will be enrolled in a 2 months supervised rehabilitation program. Evaluation will take place at recruitment time and at the end of the program (2 months).

Group Type ACTIVE_COMPARATOR

Supervised rehabilitation program.

Intervention Type OTHER

The program includes aerobic exercise, strengthening exercises, physiotherapy, psychological support and dietary advice.

Control

The patients in this arm will not be enrolled in a supervised rehabilitation program. Evaluation will take place at recruitment and at 2 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Supervised rehabilitation program.

The program includes aerobic exercise, strengthening exercises, physiotherapy, psychological support and dietary advice.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evangelismos Hospital

OTHER

Sponsor Role lead

Responsible Party

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Andreas Asimakos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Evangelismos Hospital

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 32817258 (View on PubMed)

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/

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 33428867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33148809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32398306 (View on PubMed)

Other Identifiers

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21-1-2021 22

Identifier Type: -

Identifier Source: org_study_id

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