Rehabilitation Treatment of Patients With COVID-19

Not Applicable

Completed

• Conditions: COVID-19; Pneumonia, Viral; Quality of Life; Rehabilitation
• Interventions: Other: exercises; Other: massage

• Registration Number: NCT05808361
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2023-04
• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-11
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
physical exercise	exercises	Rehabilitation program includes physical exercises, started in the first 3 days after the patient's body temperature returned to normal.
exercises and massage	exercises	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.
exercises and massage	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.

Primary Outcome Measures

Name	Time	Method
Length of stay in hospital	30 days	length of stay in hospital

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Hospital "MEDSI" in Otradnoe; 🇷🇺 Moscow, Russian Federation