NCT05808361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

April 7, 2023

Last Update Submit

April 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Length of stay in hospital

    length of stay in hospital

    30 days

Secondary Outcomes (6)

  • complete blood count

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

  • complete blood count dynamics

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

  • Complaints of fatigue

    Change of complains from baseline on day 7 during treatment

  • Complaints of fatigue dynamics

    Change of complains from 7 to 14 day during treatment

  • Biochemistry analysis

    Change of CRP from baseline on day 7 during treatment

  • +1 more secondary outcomes

Study Arms (3)

physical exercise

EXPERIMENTAL

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

Other: exercises

exercises and massage

EXPERIMENTAL

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: exercisesOther: massage

Control

NO INTERVENTION

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

Interventions

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.

exercises and massagephysical exercise
massageOTHER

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.

exercises and massage

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital "MEDSI" in Otradnoe

Moscow, 143442, Russia

Location

Related Publications (2)

  • 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.

    PMID: 32799694BACKGROUND
  • 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.

    PMID: 32840156BACKGROUND

MeSH Terms

Conditions

Pneumonia, ViralCOVID-19

Interventions

ExerciseMassage

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Danil Maliutin, MD

    Clinical Hospital "MEDSI" in Otradnoe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 11, 2023

Study Start

April 1, 2020

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations