Clinical trial NCT05808361: Rehabilitation Treatment of Patients With COVID-19
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
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Pneumonia, Viral
COVID-19
Quality of Life
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
Collaborators: name: MEDSI Clinical Hospital 1, ICU
First posted: 2023-04-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Length of stay in hospital
timeFrame: 30 days
Secondary outcomes:
measure: complete blood count
timeFrame: Change of white blood cells from baseline on day 7 during treatment
measure: complete blood count dynamics
timeFrame: Change of white blood cells from 7 to 14 day during treatment
measure: Complaints of fatigue
timeFrame: Change of complains from baseline on day 7 during treatment
measure: Complaints of fatigue dynamics
timeFrame: Change of complains from 7 to 14 day during treatment
measure: Biochemistry analysis
timeFrame: Change of CRP from baseline on day 7 during treatment
measure: Biochemistry analysis dynamics
timeFrame: Change of CRP from 7 to 14 day during treatment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinical Hospital "MEDSI" in Otradnoe
Study officials:
affiliation: Clinical Hospital "MEDSI" in Otradnoe
name: Danil Maliutin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.