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

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.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Quality of Life; Pneumonia, Viral; Rehabilitation
• Intervention / Treatment: Other: exercises; Other: massage

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 143442
    • Clinical Hospital "MEDSI" in Otradnoe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: physical exercise; Rehabilitation program includes physical exercises, started in the first 3 days after the patient's body temperature returned to normal.	Other: exercises; 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.
Experimental: exercises and massage; 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.	Other: exercises; 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.; Other: massage; 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.
No Intervention: Control; Patients received treatment according to the temporary guideline without any rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in hospital	length of stay in hospital	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete blood count	white blood cells	Change of white blood cells from baseline on day 7 during treatment
complete blood count dynamics	white blood cells	Change of white blood cells from 7 to 14 day during treatment
Complaints of fatigue	Complaints of fatigue	Change of complains from baseline on day 7 during treatment
Complaints of fatigue dynamics	Complaints of fatigue	Change of complains from 7 to 14 day during treatment
Biochemistry analysis	C-reactive protein (CRP)	Change of CRP from baseline on day 7 during treatment
Biochemistry analysis dynamics	C-reactive protein (CRP)	Change of CRP from 7 to 14 day during treatment

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Collaborators: MEDSI Clinical Hospital 1, ICU
• Investigators: Principal Investigator: Danil Maliutin, MD, Clinical Hospital "MEDSI" in Otradnoe

Publications and helpful links

General Publications

• Sun T, Guo L, Tian F, Dai T, Xing X, Zhao J, Li Q. Rehabilitation of patients with COVID-19. Expert Rev Respir Med. 2020 Dec;14(12):1249-1256. doi: 10.1080/17476348.2020.1811687. Epub 2020 Oct 12.
• Demeco A, Marotta N, Barletta M, Pino I, Marinaro C, Petraroli A, Moggio L, Ammendolia A. Rehabilitation of patients post-COVID-19 infection: a literature review. J Int Med Res. 2020 Aug;48(8):300060520948382. doi: 10.1177/0300060520948382.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; COVID-19; Pneumonia, Viral
• Other Study ID Numbers: COVID-REHAB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No