investigate the effect of aerobic exercise with and without green tea consumption on kidney function in obese and sedentary postmenopausal women
Design
The clinical trial was performed in 3 experimental groups and without control group. The samples were selected by randomized purposeful method and divided into groups by simple random method.The sample size was 29, and blindness was not done.The aim of clinical trial was to investigate the effect of aerobic exercise and green tea on kidney function.
Settings and conduct
Location: Mashhad city, Indoor swimming pool for exercise and exercise+supplement groups. Blindness was not done in this study. The present study was quasi-experimental with pre-test and post-test design.
Participants/Inclusion and exclusion criteria
entry: BMI more than 25 kg/m2; Age range between 50-65 years; At least 2 years after menopause.
No entry: Suffering from special and underlying diseases; Forced to use drug; Movement and exercise restrictions.
Intervention groups
Intervention group 1: exercise include aerobic exercise in water for 8 weeks, 3 sessions per week and 45-60 minutes with 65-75% maximum heart rate intensiti; Intervention group 2: intake green tea supplement for 8 weeks, 3 times per a day and 200 ml per serving; Intervention group 3: Exercise+Supplement include aerobic exercise in water for 8 weeks, 3 sessions per week and 45-60 minutes with 65-75% maximum heart rate intensiti+intake green tea supplement for 8 weeks, 3 times per a day and 200 ml per serving.
Main outcome variables
Kidney Function Indicators include: Creatinine, urea and uric acid
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180124038494N1
Registration date:2018-03-04, 1396/12/13
Registration timing:retrospective
Last update:2018-03-04, 1396/12/13
Update count:0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Fahime Sadat Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 2774
Email address
fahimesadat.jamali@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
2013-10-02, 1392/07/10
Actual recruitment end date
2013-10-12, 1392/07/20
Trial completion date
empty
Scientific title
The effect of aerobic exercise in water with and without green tea consumption on kidney function in sedentary postmenopausal women
Public title
Effect of aerobic exercise and green tea on kidney function in women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
BMI more than 25 kg/m2
At least 2 yaers after menopause
Not participating in sports activities at least two months before the start of the research
Exclusion criteria:
suffering from underlying and specific diseases
Forced to use drug
movemont and exercise restrictions
Age
From 50 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
29
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling, randomized purposeful method and for grouping the participants, simple random method was used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Danesh va salamat City., Between Shahid javan and Al shahidi sq., Shahid Fakouri Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.MUMS.Rec.1395.386
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
2
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
creatinine
Timepoint
48 hours before the start of the intervention and 48 hours after the end of the intervention
Method of measurement
Useing kit and autoanalyzer device
2
Description
Urea
Timepoint
48 hours before the start of the intervention and 48 hours after the end of the intervention
Method of measurement
Useing kit and autoanalyzer device
3
Description
Uric acid
Timepoint
48 hours before the start of the intervention and 48 hours after the end of the intervention
Method of measurement
Useing kit and autoanalyzer device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Aerobic exercise in water for 8 weeks, 3 sessions per week and 45-60 minutes with 65-75% maximum heart rate intensiti.
Category
Prevention
2
Description
Intervention group 2: intake green tea supplement for 8 weeks, 3 times per a day and 200 ml per serving.
Category
Prevention
3
Description
Intervention group: Exercise+Supplements: Aerobic exercise in water for 8 weeks, 3 sessions per week and 45-60 minutes with 65-75% maximum heart rate intensiti+intake green tea supplement for 8 weeks, 3 times per a day and 200 ml per serving.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Armaghan Sports Complex
Full name of responsible person
Reza Pasban
Street address
No. 23, Resalat Ave., Ferdowsi Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9899656372
Phone
+98 51 3609 0634
Fax
Email
re.pas63@yahoo.com
Web page address
http://armaghanpool.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Ferdowsi University of Mashhad
Full name of responsible person
Ahmadreza Bahrami
Street address
Azadi Sq., Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 2422
Email
a.safarnejad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Ferdowsi University of Mashhad
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
Ferdowsi University of Mashhad
Full name of responsible person
Fahime Sadat Jamali
Position
Lecturer and phd student of ferdowsi university of mashhad
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 14, Dandanpezeshkan Blvd., Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9891235731
Phone
+98 51 3501 2774
Email
fasaja88@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Fahime Sadat Jamali
Position
Lecturer and phd student of ferdowsi university of mashhad
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 14, Dandanpezeshkan Blvd., Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9899656372
Phone
+98 51 3501 2774
Email
fasaja88@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Fahime Sadat Jamali
Position
Lecturer and phd student of ferdowsi university of mashhad
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 14, Dandanpezeshkan Blvd. Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9899656372
Phone
+98 51 3501 2774
Email
fasaja88@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available