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

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)

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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.