Comparing differences female and male on oxygenation, anxiety, performance and quality of life after physiotherapy in hospitalized patients with COVID-19
The purpose of this study is to investigate the effect of physical therapy exercises on the amount of oxygenation, level of anxiety, stress, performance and quality of life in hospitalized female and male patients affected by COVID-19 virus.
Design
Before- after clinical trial study include of 24 female and 24 male COVID-19 patients, without randomization and blinding.
Settings and conduct
Hospitalized patients in the Sina hospital who affected with COVID-19 with inclusion criteria will be enter to study. Physiotherapy exercises includes of chest and limb exercises are prescribed. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized patients (20 and 65 years) who are affected by COVID-19 viruses. The hospitalization period is at least one to two weeks.
Exclusion criteria: Patients admitted on the intensive care unit or discharged from the intensive care unit. Also, patients with orthopedic, neurological and systemic disorders and pregnant women are not included in the study.
Intervention groups
Physiotherapy exercises includes of chest and limbs exercises are prescribed in female and male hospitalization patients. The setting of exercises will depends on patients conditions .
Main outcome variables
Quality of life; function; stress and anxiety; rate of oxygen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220719055493N1
Registration date:2022-09-13, 1401/06/22
Registration timing:registered_while_recruiting
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Aliaa Resan Shnen Alabbas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
aliaamail828@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing differences female and male on oxygenation, anxiety, performance and quality of life after physiotherapy in hospitalized patients with COVID-19
Public title
Difference between male and female after physiotherapy in COVID patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Female and male patients between 20-65 years old
Duration of hospitalization from one up to 2 weeks
Patients not admitted on ICU or discharged from ICU
Exclusion criteria:
Patients with orthopedic disorders, systemic disease
Neurological disorders
Pregnant females
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of faculty of rehabilitation in Tehran University of Medical Sciences
Street address
Pich-e- Shemiran, Enghelab Avenue, Faculty of rehabilitation
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2022-07-06, 1401/04/15
Ethics committee reference number
IR.TUMS.FNM.REC.1401.040
Health conditions studied
1
Description of health condition studied
Physiotherapy of patients affected with COVID
ICD-10 code
U07.1
ICD-10 code description
COVID- 19 virus infection
Primary outcomes
1
Description
Assessment of quality of life
Timepoint
Before hospitalization and after discharge
Method of measurement
Arabian version of Short-Form health survey questionnaire (SF-36)
2
Description
Assessing performance
Timepoint
Before hospitalization and after discharge
Method of measurement
By measuring of distance in 6- min walking test
3
Description
Assessment of anxiety and stress.
Timepoint
Before hospitalization and after discharge
Method of measurement
Arabic version of Depression Anxiety Stress Scale-21By questionnaire
4
Description
Measurement of oxygenation level
Timepoint
Before hospitalization and after discharge
Method of measurement
Oxiometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Breathing exercises related to the lungs (respiratory physiotherapy) + movements and exercises of upper and lower limbs prescribed according to order and patients' conditions during hospitalization. The duration of hospitalization and set of exercises was different among patients. Evaluations were done at the beginning of treatment and before discharge of hospital.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospitals
Full name of responsible person
Khadijeh Otadi
Street address
Sina Hospital, Hasan Abad squre
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Quds street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 8899 2970
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
ََAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Pich-e Shemiran, Enghelab Avenue, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Pich-e- Shemiran, Enghelab Avenue, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Pich- e- Shemiran, Enghelab Avenu, Faculty of rehabilitation
City
Tehran
Province
Tehran
Postal code
1146981111
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
kinds of treatment and results
When the data will become available and for how long
After publishing of data
To whom data/document is available
All
Under which criteria data/document could be used
For the best treatment
From where data/document is obtainable
Authors
What processes are involved for a request to access data/document