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Rehabilitation Treatment of Patients With COVID-19 (COVID-REHAB)

I

I.M. Sechenov First Moscow State Medical University

Status

Completed

Conditions

COVID-19
Rehabilitation
Quality of Life
Pneumonia, Viral

Treatments

Other: massage
Other: exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT05808361
COVID-REHAB

Details and patient eligibility

About

This is single centre retrospective study with propensity score matching. The aim of the study is to develop criteria for determining groups of patients with a new coronavirus infection based on clinical, laboratory and instrumental data for whom rehabilitation programs (physical exercises, chest massage in an electrostatic field) will be effective. Data on predictors of effective rehabilitation in COVID-19 is limited. Knowledge of predictors of possibility and efficacy of rehabilitation programs could enhance patients recovery. The main symptoms of COVID-19 involve the respiratory system and psychological function. Early rehabilitation can reduce hospital length of stay. Different patients have different degrees of dysfunction; therefore, personal plans should be developed according to the patient's age, sex, lifestyle and physical condition. Regular follow-up and rehabilitation guidance were conducted for discharged patients, focusing on improving vital capacity and cardiopulmonary endurance. There is a clear consensus that early rehabilitation is an important strategy for the treatment of polyneuropathy and myopathy in critical disease, to facilitate and improve long-term recovery and patients' functional independence, and to reduce the duration of respiratory support and hospitalization. Early rehabilitation and exercise prescriptions remain to be further optimized, especially for hospitalised patients.

Full description

The application of early rehabilitation can promote recovery of body functions; however, further studies are needed to determine the patient selection criteria and relevant mode of rehabilitation program.

A primary concern is regarding the timing of when to start a rehabilitation protocol in the face of the real threat of COVID-19.

Rehabilitation programs include physical exercises, and chest massage in an electrostatic field, started in the first 3 days after the patient's body temperature returned to normal.

The demographic and clinical data will be collected. Laboratory data (white blood cells count, C-reactive protein), and Instrumental data (pulse oxymetry, CT-scan) will be analysed. Rehabilitation evaluation - Health profile according to the quality of life questionnaire before and after each rehabilitation mode will be analysed. Exercise termination criteria: (1) Fluctuations in body temperature > 37.2°C; (2) respiratory symptoms and fatigue worsen; (3) chest tightness, chest pain, breathing difficulties, severe cough, dizziness, headache, blurred vision, palpitations, sweating, trouble standing.

Enrollment

180 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with COVID-19 admitted to the hospital with mild or moderate COVID-19 (5-50% of lung damage according to CT-scan)

Exclusion criteria

  • less than 7 days in hospital by any reason,
  • chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure), admission to ICU, atonic coma,
  • patients in whom more than 30 days have passed since the onset of the disease and before hospitalization,
  • patients who received treatment in the intensive care unit, as well as patients who died.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

180 participants in 3 patient groups

physical exercise
Experimental group
Description:
Rehabilitation program includes physical exercises, started in the first 3 days after the patient's body temperature returned to normal.
Treatment:
Other: exercises
exercises and massage
Experimental group
Description:
Rehabilitation programs include physical exercises, and chest massage in an electrostatic field, started in the first 3 days after the patient's body temperature returned to normal.
Treatment:
Other: massage
Other: exercises
Control
No Intervention group
Description:
Patients received treatment according to the temporary guideline without any rehabilitation program.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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