The objective of present study was to see the effect of eight weeks aerobic exercise on the thyroid hormones and quality of life of overweight postmenopausal women.
Design
Clinical trial with control, community based and pragmatic groups, with parallel groups, not blinded care, twenty-one sedentary women were randomly divided into two groups: sedentary control (n=11) and aerobic training (n=10)
Settings and conduct
This clinical trial includes control, community based and pragmatic groups carried out as pre-test and post-test in two intervention and control groups at Mashhad Ferdowsi University.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women aged 35-45 years old; Healthy without chronic diseases; not have done regular exercises in the last six months; Exclusion Criteria: Less than 35 years old or older than 45 years; Having any history of chronic diseases; have done regular exercise during the last six months.
Intervention groups
Intervention group: Subjects in aerobic training group underwent 8-week aerobic training of three sessions per week, 30-60 minutes per session. Subjects in this group did aerobic training at 65-75% HRmax intensity. Control group: The control group did not participate in any intervention.
Main outcome variables
Thyroxine; Triiodothyronine; Thyroid releasing hormone;Thyroid-stimulating hormone;
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120129008863N8
Registration date:2018-04-16, 1397/01/27
Registration timing:retrospective
Last update:2018-04-16, 1397/01/27
Update count:0
Registration date
2018-04-16, 1397/01/27
Registrant information
Name
Keyvan Hejazi
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1768 6790
Email address
ke_he981@stu-mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
2015-06-22, 1394/04/01
Actual recruitment end date
2016-09-22, 1395/07/01
Trial completion date
empty
Scientific title
Effect of aerobic exercise on thyroid hormones and quality of life in women
Public title
Effect of aerobic exercise on thyroid hormones and quality of life in women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 35-45years old
Healthy without chronic diseases
Exclusion criteria:
Doing regular exercise during the last six months
Age
From 35 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
21
Actual sample size reached:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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 Ferdowsi University of Mashhad
Street address
Paradise Daneshgah, Azadi Square, Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad, IRAN
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48979
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.MUMS.REC.1394.42314
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Thyroxine
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)
2
Description
Triiodothyronine
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)
3
Description
Thyroid-stimulating hormone
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)
4
Description
Thyrotropin-releasing hormone
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)
5
Description
Quality of life
Timepoint
Eight weeks
Method of measurement
Quality of life of subjects before and at the end of study and measuring by quality of Life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Subjects in aerobic training group underwent aerobic training for eight weeks, 3 sessions per week for 30-60 min. Subjects of this group doing aerobic training with intensity of 65-75% HRmax.
Category
Other
2
Description
Control group: Subjects of the control group did not have any regular physical activities during the period of study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ferdowsi University of Mashhad
Full name of responsible person
Mehrdad Fathie
Street address
Paradise Daneshgah, Azadi Square, Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad
City
Mashad
Province
Razavi Khorasan
Postal code
91779-48979
Phone
+98 51 3883 3910
Email
mfathei@um.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Mehrdad Fathi
Street address
Paradise Daneshgah, Azadi Square, Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad
City
Mshhad
Province
Razavi Khorasan
Postal code
91779-48979
Phone
+98 51 3883 3910
Email
mfathei@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Council of 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
Toos Institute of Higher Education
Full name of responsible person
Keyvan Hejazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Esteghlal Square, Faramarz Abbasi St. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9197913116
Phone
+98 51 3606 3044
Email
keyvanhejazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Toos Institute of Higher Education
Full name of responsible person
Keyvan Hejazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Esteghlal Square, Faramarz Abbasi St. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9197913116
Phone
+98 51 3606 3044
Email
keyvanhejazi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Toos Institute of Higher Education
Full name of responsible person
Keyvan Hejazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Esteghlal Square, Faramarz Abbasi St. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9197913116
Phone
+98 51 3606 3044
Email
keyvanhejazi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In order to observe ethical principles in research, personal data and collected data from subjects will remain with the researcher.