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

NCT04935437 | Completed

• 1 other identifier: 21-1-2021 22
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Keywords

Rehabilitation; post COVID-19 sequalae

Outcome Measures

Primary Outcomes (4)

• Assessment of fatigue with FACIT fatigue Scale

  The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). Score range is from 0-52 and the higher the score the better QOL (quality of life).

  2 months

• Assessment of fatigue using chalder fatigue scale.

  The chalder fatigue scale is scored bimodally with a range from 0 to 11 assessing the number of symptoms. It is also scored in Likert style with a range of 0-33 in order to asses the severity of symptoms. The higher the scores indicate more and more severe symptoms.

  2 months

• Assessment of fatigue with Fatigue Severity Scale

  Assessment of fatigue using the Fatigue Severity Scale. The minimum score is 9 and maximum score is 63. Higher values mean higher fatigue severity.

  2 months

• Assessment of respiratory symptoms after COVID-19 with CAT.

  Assessment of symptoms after COVID-19 using the COPD Assessment Test (CAT). Minimum score is 0 and maximum score is 40. Patients with higher scores are more impaired. Patients with a score of 10 or more are considered significantly impaired after COVID-19 infection.

  2 months

Secondary Outcomes (17)

• Assessment of quality of life using SF-36 questionnaire.

  2 months

• Assessment of shortness of breath

  2 months

• Assessment of functional capacity with 6MWT.

  2 months

• Assessment of symptoms after COVID-19 with PCFS.

  2 months

• Assessment of lower extremity strength

  2 months.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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).

Other: Supervised rehabilitation program.

Control

NO INTERVENTION

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

Interventions

Supervised rehabilitation program. OTHER

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

Intervention

Eligibility Criteria

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

You may qualify if:

• 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:
• Patients admitted to the ICU, especially those who were intubated.
• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (1)

Evangelismos Hospital

Athens, Attica, 10676, Greece

Location

Related Publications (5)

• 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.

  PMID: 32817258 BACKGROUND

• 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/

  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.

  PMID: 33428867 BACKGROUND

• 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.

  PMID: 33148809 BACKGROUND

• 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.

  PMID: 32398306 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Before and after trial matched cohort trial.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 23, 2021
• Study Start: January 21, 2021
• Primary Completion: August 1, 2021
• Study Completion: February 26, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)