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

Primary Purpose

Rehabilitation, Pneumonia, Viral, COVID-19

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
exercises
massage
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinical Hospital "MEDSI" in Otradnoe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

physical exercise

exercises and massage

Control

Arm Description

Rehabilitation program includes physical exercises, started in the first 3 days after the patient's body temperature returned to normal.

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.

Patients received treatment according to the temporary guideline without any rehabilitation program.

Outcomes

Primary Outcome Measures

Length of stay in hospital
length of stay in hospital

Secondary Outcome Measures

complete blood count
white blood cells
complete blood count dynamics
white blood cells
Complaints of fatigue
Complaints of fatigue
Complaints of fatigue dynamics
Complaints of fatigue
Biochemistry analysis
C-reactive protein (CRP)
Biochemistry analysis dynamics
C-reactive protein (CRP)

Full Information

First Posted
April 7, 2023
Last Updated
April 11, 2023
Sponsor
I.M. Sechenov First Moscow State Medical University
Collaborators
MEDSI Clinical Hospital 1, ICU
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1. Study Identification

Unique Protocol Identification Number
NCT05808361
Brief Title
Rehabilitation Treatment of Patients With COVID-19
Acronym
COVID-REHAB
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
Collaborators
MEDSI Clinical Hospital 1, ICU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation, Pneumonia, Viral, COVID-19, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical exercise
Arm Type
Experimental
Arm Description
Rehabilitation program includes physical exercises, started in the first 3 days after the patient's body temperature returned to normal.
Arm Title
exercises and massage
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients received treatment according to the temporary guideline without any rehabilitation program.
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
massage
Intervention Description
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 Outcome Measure Information:
Title
Length of stay in hospital
Description
length of stay in hospital
Time Frame
30 days
Secondary Outcome Measure Information:
Title
complete blood count
Description
white blood cells
Time Frame
Change of white blood cells from baseline on day 7 during treatment
Title
complete blood count dynamics
Description
white blood cells
Time Frame
Change of white blood cells from 7 to 14 day during treatment
Title
Complaints of fatigue
Description
Complaints of fatigue
Time Frame
Change of complains from baseline on day 7 during treatment
Title
Complaints of fatigue dynamics
Description
Complaints of fatigue
Time Frame
Change of complains from 7 to 14 day during treatment
Title
Biochemistry analysis
Description
C-reactive protein (CRP)
Time Frame
Change of CRP from baseline on day 7 during treatment
Title
Biochemistry analysis dynamics
Description
C-reactive protein (CRP)
Time Frame
Change of CRP from 7 to 14 day during treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danil Maliutin, MD
Organizational Affiliation
Clinical Hospital "MEDSI" in Otradnoe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital "MEDSI" in Otradnoe
City
Moscow
ZIP/Postal Code
143442
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
32799694
Citation
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.
Results Reference
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PubMed Identifier
32840156
Citation
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.
Results Reference
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Learn more about this trial

Rehabilitation Treatment of Patients With COVID-19

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