Investigation of effect of 8 weeks of aerobic exercise and garlic supplementation on fatigue and cardiovascular risk factors in women with rheumatoid arthritis.
Design
Pre-test and post-test design with parallel, double-blind, randomized groups using variable block method will be performed on 40 patients.
Settings and conduct
The present study will be conducted at Sistan and Baluchestan University. For this purpose, three groups are subjected to three interventions: garlic consumption, aerobic exercise and garlic consumption + aerobic exercise. For blindness, the third group receives placebo in addition to exercise. Only supervisor knows the content of the capsules used by the exercise groups.
Participants/Inclusion and exclusion criteria
Participants in this study are women with rheumatoid arthritis.
Inclusion criteria: Rheumatoid arthritis disease, age 27 to 45 years and being of childbearing age.
Exclusion Criteria: Cardiovascular disease.
Intervention groups
Intervention group 1: Will do aerobic exercise for 8 weeks with a ergometer, 3 sessions/week and each session for 60 minutes (20 minutes of warm-up and cooling, 30 to 40 minutes of exercise with an intensity of 70% of VO2max) During this time, receives a placebo(Guaranteed cornstarch made by Etminan Hadaf Toos Company in the amount of 500 mg in coatings similar to garlic supplement capsules by the researcher))twice a day.
Intervention group 2: In addition to the aerobic exercise program, will take a garlic supplement(under the brand name Garcin, manufactured by Gol Daroo Company) twice/day at a dose of 500 mg during the research period.
Intervention group 3: For 8 weeks, receive only garlic supplement, 500 mg, twice/day.
Main outcome variables
Fatigue; Systolic blood pressure; Low Density Lipoprotein; total Cholesterol.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041097N5
Registration date:2022-02-01, 1400/11/12
Registration timing:retrospective
Last update:2022-02-01, 1400/11/12
Update count:0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Reza Delavar
Name of organization / entity
The University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3113 2674
Email address
delavar@ped.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-09-16, 1400/06/25
Actual recruitment start date
2021-11-06, 1400/08/15
Actual recruitment end date
2021-11-11, 1400/08/20
Trial completion date
2022-06-03, 1401/03/13
Scientific title
The effect of eight weeks of aerobic exercise and garlic supplementation on fatigue and cardiovascular risk factors in women with rheumatoid arthritis
Public title
Effect of aerobic exercise and garlic consumption on rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with rheumatoid arthritis
Women with rheumatoid arthritis who are of childbearing age.
Women with rheumatoid arthritis aged 27 to 45 years.
Exclusion criteria:
Women with rheumatoid arthritis who also have cardiovascular disease.
Age
From 27 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is done by simple randomization method. First, 3 groups based on the number of participants in each group and the number of groups required for the trial (placebo, exercise, exercise and placebo), are formed and then a 2 digit code is given to each subject without any criteria from 01 to 48. Then a number is selected in the table of random numbers, with the eyes closed, and in the row to the right of the desired number, up to 16 two-digit numbers less than 48 for the first group, 16 second two-digit numbers for the second group and 16 third two-digit numbers for the third group will be considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present trial, there are two groups of exercise, one receiving supplement and the other receiving placebo. The Supervisor is the only one who is aware of the contents of the capsules containing the supplement and placebo, and provides these capsules to the evaluator students for the use of the subjects in the supplement and exercise + supplement groups. Thus, participants, evaluators and statistical analysts do not know which group is a exercise group and which group is a exercise + supplement group.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sistan and Baluchestan University.
Street address
Central Organization of Sistan and Baluchestan University, University Blvd, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷-۴۵۸۴۵
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.USB.REC.1399.001
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05.04
ICD-10 code description
Felty's syndrome, hand
Primary outcomes
1
Description
Systolic blood pressure above 14 mm Hg.
Timepoint
24 hours before and 24 hours after the first and last session of the exercise program.
Method of measurement
By arm blood pressure monitor
2
Description
Total cholesterol above 250 mg per deciliter.
Timepoint
24 hours before and 24 hours after the first and last session of the exercise program.
Method of measurement
Total cholesterol diagnostic kit made by Pars Azmoun company by photometric method
3
Description
Blood LDL level above 160 mg per deciliter.
Timepoint
24 hours before and 24 hours after the first and last session of the exercise program.
Method of measurement
Low density lipoprotein diagnostic kit made by Pars Azmon Company by photometric method
4
Description
Fatigue rate above 3 points
Timepoint
24 hours before and 24 hours after the first and last session of the exercise program.
Method of measurement
Fatigue Symptom Inventory questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: This group pedals on the ergometer (Body sculpture brand made in China)for eight weeks, 3 sessions per week, in each session after 10 minutes of warm-up, with an intensity of 70% of the maximum oxygen consumption, and then cools down for 10 minutes and daily receives 2 rounds of placebo (corn starch under the Zamen brand, manufactured by Etminan Hadaf Toos Company, which was prepared in the amount of 500 mg in coatings similar to garlic supplement capsules by the researcher).
Category
Behavior
2
Description
Second intervention group: This group pedals on the ergometer for eight weeks, 3 sessions per week and in each session after 10 minutes of warm-up, with an intensity of 70% of the maximum oxygen consumption, and then cools down for 10 minutes. Take 2 times a day garlic supplement with Garcin brand made by Goldaro company, Iran in a dose of 500 mg.
Category
Treatment - Other
3
Description
Third intervention group: This group receives 500 mg of garlic supplement(with brand of Garcin produced by Gol daro Company), twice a day for eight weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn abitaleb Hospital
Full name of responsible person
Mahnaz Sandoughi
Street address
Ali Ibn Abitaleb Hospital, Salamat Blvd, Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
mahnazsandoughi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Sistan and Baluchestan
Full name of responsible person
DorMohamad Kordi Tamandani
Street address
Central Organization of Sistan and Baluchestan University, University Blvd, Zahedan, Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-45845
Phone
+98 54 3113 2000
Email
dor_kordi@science.usb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Sistan and Baluchestan
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
The University Sistan and Baluchestan
Full name of responsible person
Reza Delavar
Position
Assiatant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Sports Sciences, Sistan and Baluchestan University, University Street.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 2674
Email
delavar@ped.usb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Reza ِDelavar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Sport Sciences, Faculty of Psychology and Educational Sciences, University of Sistan and Baluchestan, , University Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6724
Email
delavar@ped.usb.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Reza ِDelavar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Sport Sciences, Faculty of Psychology and Educational Sciences, University of Sistan and Baluchestan, , University Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6724
Email
delavar@ped.usb.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
Subjects' information is shared with other researchers after being Unrecognizable.
When the data will become available and for how long
After the publication of the final research report.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Citing the findings by citing the source
From where data/document is obtainable
By email address
What processes are involved for a request to access data/document
After receiving the request via email and reviewing the request by the scientific officer of the research, will be answered.