The aim of the current study is to investigate the effects of 8 weeks aerobic exercise on the some hematologic factors of patients with RA.Design: In this clinical trial study, 33 women with RA participated voluntary in this study.
All the participants were randomly assigned to two study groups, control (17) and training (16) that using a computer-based random digit generator using the admission numbers. Those who were assigned to the training group were placed in a training program including aerobic cycling which was done on the stationary bike, 3 sessions per week with intensity about 65% of reserved heart rate for 8 weeks. The participants used the same pharmacological treatments. The hemoglobin (Hb), hematocrit and RBC count was measured with standard methods before and after the intervention in all the subjects and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072923394N1
Registration date:2015-08-28, 1394/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-28, 1394/06/06
Registrant information
Name
Yaser Jafar Shapoorabadi
Name of organization / entity
shahrekord University
Country
Iran (Islamic Republic of)
Phone
+98 913 565 0081
Email address
sh.yaser91@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shahrekord University
Expected recruitment start date
2015-04-13, 1394/01/24
Expected recruitment end date
2015-06-14, 1394/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Aerobic Exercise on Hematologic Indices of Women with Rheumatoid Arthritis
Public title
Effects of Aerobic Exercise on Hematologic Indices of Women with Rheumatoid Arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: All patients who had diagnosis of RA with involving their lower limbs; had not participated in any activities at least in the last three years; They should be able to do exercise protocols of this study.
Exclusion criteria: Individuals had any known heart diseases; renal; pulmonary or liver disorders; diabet and duodenal ulcer; Also if they had self-medication; diden't have any leaning to continue the study.
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sarekord University
Street address
Sharekord University, rahbar Boulevard, Chaharmahal Bakhtiari ,iran
City
Sharekord
Postal code
Approval date
2011-03-14, 1389/12/23
Ethics committee reference number
122/5726
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05.3
ICD-10 code description
Rheumatoid arthritis with involvement of other organs and systems
Primary outcomes
1
Description
Hematologic Indices
Timepoint
two days before and after the training period in a fasting status
Method of measurement
Blood cell differential count, Counter XL22
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and 2 months after the intervention.
Method of measurement
Questionnaires
Intervention groups
1
Description
Control group: patients in control group used only pharmacological treatments (methotrexate 7.5 mg per week and prednisolone 5 mg per day). They didn't participate in any exercise programs.
Category
Treatment - Drugs
2
Description
Intervention group: patients in training group, in addition to use methotrexate 7.5 mg per week and prednisolone 5 mg per day, they participated in an aerobic cycling exercise which was done on the stationary bike, 3 sessions per week for 8 weeks that based on the principles of exercise science, under the supervision of a sport medicine and consulting with the treating physician.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfahan Alzahra Hospital
Full name of responsible person
Dr Mansour Salesi
Street address
Department of Rheumatology, Alzahra Hospital, Sofe Avenue, Esfahan, Iran
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University
Full name of responsible person
Dr Mortza Hosseini
Street address
Vice chancellery of Research, Shahrekord University, Rahbar Boulevard, Chaharmahal Bakhtiari ,Iran
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sahrekord University
Full name of responsible person
Yaser Jafari
Position
Exercise Physiology, Master of Sciencet
Other areas of specialty/work
Street address
Shahrekord University, Rahbar Boulevard, Chaharmahal Bakhtiari ,Iran
City
Shahrekord
Postal code
Phone
+98 38 3232 4407
Fax
Email
sh.yaser91@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Babak Vahdatpour
Position
Assistant Professor
Other areas of specialty/work
Street address
Alzahra Hospital, Sofe Boulevard, Esfahan
City
Esfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
Vahdatpour@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Yaser Jafari
Position
Exercise Physiology, Master of Sciencet
Other areas of specialty/work
Street address
Shahrekord University, Rahbar Boulevard, Chaharmahal Bakhtiari ,Iran
City
Shahrekord
Postal code
Phone
+98 38 3232 4407
Fax
Email
sh.yaser91@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)