Protocol summary

Study aim
The purpose of this study is to evaluate eight weeks of progressive aerobic exercises with curcumin supplementation on inflammatory indices, lipid indices and cardio-pulmonary function in obese girls who have recovered from corona after being discharged from the hospital.
Design
This research is a semi-experimental method and a clinical trial in the form of a pre-test and a post-test, which will be conducted after ethical approval with an ethics ID from the secretariat of the national ethics committee based in Ilam University and registration in the clinical trial center. The statistical population will include inactive obese girls with an age range of 25-35 years with a body mass index of 35 ± 5 referring to sports clubs in Kermanshah city in 1402.
Settings and conduct
With the presence of a nursing expert from the Kermanshah health center, they will be present at the central (reference) laboratory of Kermanshah
Participants/Inclusion and exclusion criteria
. None of the subjects had a history of chronic diseases such as cardiovascular diseases, diabetes, various cancers, kidney and digestive disorders, or any type of injury or problem that prevents them from participating in physical activities.
Intervention groups
Four experimental groups: experimental group 1 (progressive aerobic exercise + curcumin supplement 10 people), experimental group 2 (progressive aerobic exercise + placebo 10 people), experimental group 3 (curcumin supplement 10 people) and experimental group 4 (control / no intervention 10 people) will be placed.
Main outcome variables
Inflammatory indices (IL-6, TNF-a), lipid indices (TG, TC, LDL, HDL) and cardio-respiratory function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221213056809N2
Registration date: 2023-05-26, 1402/03/05
Registration timing: prospective

Last update: 2023-05-26, 1402/03/05
Update count: 0
Registration date
2023-05-26, 1402/03/05
Registrant information
Name
Vahid Kazemizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4522 1718
Email address
v.kazemizadeh@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-31, 1402/03/10
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of progressive aerobic exercises with curcumin supplementation on inflammatory indices, lipid indices and cardio-pulmonary function in obese girls recovered from corona
Public title
The effect of progressive aerobic exercises along with curcumin supplementation on physiological indicators in obese girls recovered from corona
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 25-35 Recovered from corona disease 8 months of recovery after contracting the corona disease Body mass index greater than 25 Being female
Exclusion criteria:
History of chronic diseases such as cardiovascular diseases, diabetes, various cancers, kidney, and digestive disorders Smoking history Having any type of injury or problem that prevents participation in physical activities
Age
From 25 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be examined by simple random selection in four groups. In relation to randomization, the names of 40 subjects are written on special cards and placed in a bag, and the cards are selected one after the other. After choosing each card from the bag, the card was placed in the bag again.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Supplementation will be distributed based on the randomization results announced by the laboratory supervisor among the intervention group and placebo in the control group by the laboratory officials, and the researchers will not know about the randomization results and the type of packaging they have delivered. subjects. The researcher only needs to prepare the necessary supplement for the intervention and deliver it to the laboratory supervisor.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ilam University
Street address
Ilam Province, Ilam, Research Blvd
City
Ilam
Province
Ilam
Postal code
6939177111
Approval date
2023-04-24, 1402/02/04
Ethics committee reference number
IR.ILAM.REC.1402.003

Health conditions studied

1

Description of health condition studied
Covid 19
ICD-10 code
UO8
ICD-10 code description
Personal history of COVID-19

Primary outcomes

1

Description
Inflammatory indices (IL-6, TNF-a)
Timepoint
In the pre-test stage and after 8 weeks in the post-test stage, after 12 hours of fasting, the subjects will be present at the Kermanshah Central Laboratory (Reference) in the presence of a nursing expert from the Kermanshah Health Center.
Method of measurement
Inflammatory indices (IL-6, TNF-a) will be measured using the ELISA kit of Carmania Parsgene Company, made in Iran, by the sandwich method.

2

Description
Lipid indices (TG, TC, LDL, HDL)
Timepoint
In the pre-test stage and after 8 weeks in the post-test stage, after 12 hours of fasting, the subjects will be present at the Kermanshah Central Laboratory (Reference) in the presence of a nursing expert from the Kermanshah Health Center.
Method of measurement
Lipid profile will be measured using bionic kit and enzymatic method.

3

Description
Cardiorespiratory function
Timepoint
In the pre-test stage and after 8 weeks in the post-test stage, after 12 hours of fasting, the subjects will be present at the Kermanshah Central Laboratory (Reference) in the presence of a nursing expert from the Kermanshah Health Center.
Method of measurement
In relation to pulmonary function evaluation, the spirometer test will be used using the spirometer (Spirolab New) brand (MIR) made in Italy to record the pulmonary function index.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: experimental group 1 (progressive aerobic exercise + curcumin supplement, 10 people), eight weeks of aerobic activity with a frequency of three times a week for one hour and consumption of two to three capsules of curcumin according to the individual's body mass index.
Category
Treatment - Drugs

2

Description
Intervention group: experimental group 2 (progressive aerobic exercise + placebo 10 people), eight weeks of aerobic activity with a frequency of three times a week for one hour and placebo consumption of capsules containing starch
Category
Treatment - Drugs

3

Description
Intervention group: experimental group 3 (curcumin supplement 10 people), taking two to three capsules of curcumin according to the body mass index of the person and not prescribing aerobic exercise
Category
Treatment - Drugs

4

Description
Control group: experimental group 4 (control/no intervention 10 people), no intervention group without supplement prescription and exercise
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ilam University
Full name of responsible person
Nabi Shamsaei
Street address
Ilam Province, Ilam, Research Blvd
City
Ilam
Province
Ilam
Postal code
6939177111
Phone
+98 918 344 7830
Email
na.shamsaei@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University
Full name of responsible person
Alireza Tab
Street address
Ilam Province, Ilam, Research Blvd
City
Ilam
Province
Ilam
Postal code
6939177111
Phone
+98 45 5924 1201
Email
na.shamsaei@yhoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University
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
Razi University
Full name of responsible person
Vahid Kazemizadeh
Position
Visiting Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Kermanshah Province, Kermanshah, Zakariya Razi Blvd,
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Phone
+98 83 4522 1718
Email
vahid13k17@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University
Full name of responsible person
Nabi Shamsaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ilam Province, Ilam, Research Blvd
City
Ilam
Province
Ilam
Postal code
693917111
Phone
+98 84 5924 1000
Email
na.shamsaei@yahoo.cim

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Kazemizadeh
Position
Visiting Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Kermanshah Province, Kermanshah, Zakariya Razi Blvd,
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Phone
+98 83 4522 1718
Email
vahid13k17@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
If you need more information about the research, the required information will be shared through an official email to the person in charge.
When the data will become available and for how long
6 months
To whom data/document is available
Professors, students
Under which criteria data/document could be used
If you need more information about the research
From where data/document is obtainable
Through an official email to the responsible person
What processes are involved for a request to access data/document
3 months
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