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

E

Evangelismos Hospital

Status

Completed

Conditions

Rehabilitation

Treatments

Other: Supervised rehabilitation program.

Study type

Interventional

Funder types

Other

Identifiers

NCT04935437
21-1-2021 22

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

55 participants in 2 patient groups

Intervention
Active Comparator group
Description:
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).
Treatment:
Other: Supervised rehabilitation program.
Control
No Intervention group
Description:
The patients in this arm will not be enrolled in a supervised rehabilitation program. Evaluation will take place at recruitment and at 2 months.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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