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Completed

NCT Number: NCT05808361

Rehabilitation Treatment of Patients With COVID-19

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital "MEDSI" in Otradnoe

Moscow, 143442, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercises

Other

The complex of therapeutic exercises included exercises in the initial position lying, sitting and standing. In active and static motor modes under the control of saturation, blood pressure, heart rate and respiratory rate.

The complex included breathing exercises with the inclusion of compensatory respiratory muscles, elements of sound and drainage gymnastics, and diaphragmatic breathing. Therapeutic gymnastics was carried out in the form of individual lessons with an exercise therapy instructor, a course of 10 procedures, daily, the duration was 20 minutes.

Massage

Other

Hardware massage in the electrostatic field with a frequency of 30/60 Hz of the chest area consisted of 10 procedures, daily, the duration of the procedure was 20 minutes.

Primary outcomes

  1. Length of stay in hospital

    Time frame: 30 days

    length of stay in hospital

Secondary outcomes

  1. complete blood count

    Time frame: Change of white blood cells from baseline on day 7 during treatment

    white blood cells

  2. complete blood count dynamics

    Time frame: Change of white blood cells from 7 to 14 day during treatment

    white blood cells

  3. Complaints of fatigue

    Time frame: Change of complains from baseline on day 7 during treatment

    Complaints of fatigue

  4. Complaints of fatigue dynamics

    Time frame: Change of complains from 7 to 14 day during treatment

    Complaints of fatigue

  5. Biochemistry analysis

    Time frame: Change of CRP from baseline on day 7 during treatment

    C-reactive protein (CRP)

  6. Biochemistry analysis dynamics

    Time frame: Change of CRP from 7 to 14 day during treatment

    C-reactive protein (CRP)

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Collaborators

  • MEDSI Clinical Hospital 1, ICU

Registry information

Official study title

Rehabilitation Treatment of Patients With COVID-19 in an Infectious Diseases Hospital, Selection of Patients and Efficacy Criteria: A Retrospective Study With Propensity Score Matching.

Acronym: COVID-REHAB

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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