RehabilitationCOVID-REHABNCT05808361
Rehabilitation Treatment of Patients With COVID-19
A study testing exercises and massage in people with Rehabilitation and Pneumonia, Viral, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rehabilitation, Pneumonia, Viral, COVID-19
- What is being tested?
- exercises and massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2020to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with COVID-19 admitted to the hospital with mild or moderate COVID-19 (5-50% of lung damage according to CT-scan)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Rehabilitation, Pneumonia, Viral, COVID-19, Quality of Life
- Being tested
- exercises, massage
- Medical subject headings
- Pneumonia, Viral, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| physical exercise | Experimental | Rehabilitation program includes physical exercises, started in the first 3 days after the patient's body temperature returned to normal. Receives: 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. Receives: Other: exercises; Other: massage |
| Control | No intervention | Patients received treatment according to the temporary guideline without any rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in hospital
length of stay in hospital
Measured: 30 days
Secondary outcomes (6)
complete blood count
white blood cells
Measured: Change of white blood cells from baseline on day 7 during treatment
complete blood count dynamics
white blood cells
Measured: Change of white blood cells from 7 to 14 day during treatment
Complaints of fatigue
Complaints of fatigue
Measured: Change of complains from baseline on day 7 during treatment
Complaints of fatigue dynamics
Complaints of fatigue
Measured: Change of complains from 7 to 14 day during treatment
Biochemistry analysis
C-reactive protein (CRP)
Measured: Change of CRP from baseline on day 7 during treatment
Biochemistry analysis dynamics
C-reactive protein (CRP)
Measured: Change of CRP from 7 to 14 day during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Apr 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- MEDSI Clinical Hospital 1, ICU
- Responsible party
- Sponsor
- Investigators
- Danil Maliutin, MD, Principal investigator, Clinical Hospital "MEDSI" in Otradnoe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808361
- Sponsor's protocol ID
- COVID-REHAB
- Acronym
- COVID-REHAB
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32799694Demeco 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.
PubMed 32840156
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05808361
- Acronym / sponsor ID
- COVID-REHAB / COVID-REHAB
- Conditions
- Rehabilitation, Pneumonia, Viral, COVID-19, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Collaborators
- MEDSI Clinical Hospital 1, ICU
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| physical exercise | Experimental | Other: exercisesRehabilitation program includes physical exercises, started in the first 3 days after the patient's body temperature returned to normal. |
| exercises and massage | Experimental | Other: exercises, Other: massageRehabilitation 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. |
| Control | No intervention | –Patients received treatment according to the temporary guideline without any rehabilitation program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with COVID-19 admitted to the hospital with mild or moderate COVID-19 (5-50% of lung damage according to CT-scan)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisesThe 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 | exercises and massage, physical exercise |
| massageHardware 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. | Other | exercises and massage |
Primary outcome
Length of stay in hospital
Time frame: 30 days
length of stay in hospital
6 secondary outcomes
complete blood count
Time frame: Change of white blood cells from baseline on day 7 during treatment
complete blood count dynamics
Time frame: Change of white blood cells from 7 to 14 day during treatment
Complaints of fatigue
Time frame: Change of complains from baseline on day 7 during treatment
Complaints of fatigue dynamics
Time frame: Change of complains from 7 to 14 day during treatment
Biochemistry analysis
Time frame: Change of CRP from baseline on day 7 during treatment
Biochemistry analysis dynamics
Time frame: Change of CRP from 7 to 14 day during treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 32799694Sun 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.
- Background: PubMed 32840156Demeco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danil Maliutin, MD principal investigator
Clinical Hospital "MEDSI" in Otradnoe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises and massage in people with Rehabilitation and Pneumonia, Viral, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in hospital (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05808361, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.