Acute and chronic effects of a course of aerobic exercise training and garlic supplementation on serum levels of interleukin 6 (IL6), erythrocyte sedimentation rate (ESR) and fatigue in women with Rheumatoid Arthritis
Evaluation of acute and chronic effects of aerobic exercise and garlic supplementation on serum levels of interleukin 6 (IL6), erythrocyte sedimentation rate (ESR) and fatigue in women with rheumatoid arthritis
Design
A clinical trial with parallel, double-blind, randomized groups on 45 patients. The variable block method is used for randomization.
Settings and conduct
The training program will include 8 weeks of work with a ergometer bicycle, 3 sessions/week and each session for 60 minutes with a heart rate of 70% of the maximum heart rate.
Exercise+supplement group, in addition to exercise, receive garlic supplement (at a dose of 500 mg twice/day). Exercise group+placebo, in addition to exercise, receive starch with a garlic-like appearance, and the supplemement group, only receives garlic supplements.
Exercises will performed in the Moin Stadium of Sistan and Baluchestan University and diagnostic tests are performed in the laboratory of Dr. Dabiri in Zahedan.
For blindness, subjects and evaluators will be unaware of the exercise+placebo and supplement+exercise groups.
1- Exercise group: 8 weeks of work with a ergometer bicycle, 3 sessions per week and each session for a duration 60 minutes with a heart rate of 70% of the maximum heart rate.
2- Exercise+supplement group: In addition to the 8-week exercise program, they also take garlic supplements for 8 weeks (at a dose of 500 mg twice a day).
3- Supplement group: receives only garlic supplement for 8 weeks.
Main outcome variables
Serum levels of IL-6; Erythrocyte sedimentation rate and changes in fatigue due to aerobic exercise and garlic supplementation in rheumatoid arthritis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041097N4
Registration date:2021-11-27, 1400/09/06
Registration timing:retrospective
Last update:2021-11-27, 1400/09/06
Update count:0
Registration date
2021-11-27, 1400/09/06
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
2022-03-11, 1400/12/20
Scientific title
Acute and chronic effects of a course of aerobic exercise training and garlic supplementation on serum levels of interleukin 6 (IL6), erythrocyte sedimentation rate (ESR) and fatigue in women with Rheumatoid Arthritis
Public title
The effect of aerobic exercise and garlic supplementation on interleukin 6 (IL6), erythrocyte sedimentation rate (ESR) and fatigue in women with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Rheumatoid arthritis patients
Women who are menstruating
The age range of 25 - 45 years
Exclusion criteria:
Cardiovascular disease
Menopausal women
Age
From 27 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation method used with variable blocks. 3 groups of 15 people were considered and the subjects were randomly divided into three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
- Participants in the experimental groups (supplement and placebo) are unaware of taking the supplement or placebo.
- In addition to participants, outcome assessors are unaware of complementary and placebo groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Sistan and Baluchestan University
Street address
Central Organization of Sistan and Baluchestan University, University Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۵۸۴۵
Approval date
2021-04-22, 1400/02/02
Ethics committee reference number
IR.USB.REC.1400.020
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05.049
ICD-10 code description
Felty's syndrome, unspecified hand
Primary outcomes
1
Description
Inflammatory factor interleukin-6, the amount of which is above 20 pg/ml by ELISA kit.
Timepoint
24 hours before the first session of the exercise training program and 24 hours after the last session of the exercise training program.
Method of measurement
Interleukin-6 ELISA kit
2
Description
Erythrocyte Sedimentation Rate above 35 mm/hr.
Timepoint
24 hours before and 24 hours after the first session and the last session of the exercise training program.
Method of measurement
Westergren method.
3
Description
Fatigue rate, which was considered above 3 on average
Timepoint
24 hours before and 24 hours after the first session and the last session of the exercise training program.
Method of measurement
Fatigue Severity Inventory (FSI) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: A group that performs 8 weeks of aerobic exercise, 3 sessions per week and 1 hour per session with an intensity of 70% of the maximum heart rate on the ergometer bicycle.
Category
Behavior
2
Description
Intervention group 2: The group that in addition to aerobic exercise training also receives a garlic supplement at a dose of 500 mg, twice a day.
Category
Treatment - Other
3
Description
Intervention group 3: The group that receives only garlic supplement at a dose of 500 mg twice a day for 8 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
Persian Gulf Highway - Salamat Boulevard - Ali Ibn Abitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Fax
Email
public@zaums.ac.ir
Web page address
https://zaums.ac.ir/sites.page
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Sandoughi
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
public@zaums.ac.ir
Web page address
https://zaums.ac.ir/default.page
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
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 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 Bluchestan
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to the subjects after their non-identification and information data related to the main outcome
When the data will become available and for how long
From 2023/03/11
To whom data/document is available
Researchers working in universities
Under which criteria data/document could be used
All interested researchers
From where data/document is obtainable
By email address: delavar@ped.usb.ac.ir
What processes are involved for a request to access data/document
After reviewing the application received by the scientific responsible for research, the request will be answered via email.