Objectives: This study aims to determine the effect of aerobic exercise and nutrition education on quality of life and early menopause symptoms.
Design: Four parallel arm Randomized Controlled Trial.
Setting and conduct: This study will be conducted in Kaleibar city, located in East Azerbaijan- Iran. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment. Eligible women will be randomly assigned into four groups of 27 subjects with block sizes of 4 and 8, stratified by menopausal status.
Participants: 108 menopause or perimenopause married women aged 45 to 60 years old suffering from early menopause symptoms.
Interventions: The three intervention groups will receive aerobic exercise, nutrition education or both, respectively. The control group will receive no intervention. Exercise program includes walking three times per week for 12 weeks with 60 to 70% of heart rate reserve, under direct supervision of a person from research team. Nutrition education includes three educational sessions; about 45 to 60 minutes lecture and group discussion; held for groups of 10 to 17 persons for three consecutive weeks. At the end of the first session, a booklet will be given to reinforce the education.
Main outcome measures: Early menopause symptoms and quality of life will be assessed by the Green Scale questionnaire and menopause quality of life questionnaire (MENQOL), respectively at baseline, 8 and 12 weeks after starting the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111210324N6
Registration date:2013-01-15, 1391/10/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-01-15, 1391/10/26
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic exercise and nutrition education on quality of life and early menopause symptoms: a randomized controlled trial
Public title
The effect of aerobic exercise and nutrition education on quality of life and early menopause symptoms in perimonopause and monopause women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Perimenopause or menopause women aged 45 to 60 years old; suffering from hot flashes; being literate or having an educated one among family member
Exclusion criteria: taking estrogens during the last three months; having exercise contraindications; doing regular exercise (more than 2 times per week for at least 30 minutes each time) during last three months; Having known thyroid, cardio-vascular, diabetes or mental diseases; following a specific diet; experiencing severe stressors such as the death of first-degree relatives in the last month.
Age
From 45 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, and East Azerbaijan
City
Tabriz
Postal code
Approval date
2012-12-04, 1391/09/14
Ethics committee reference number
91153
Health conditions studied
1
Description of health condition studied
Early menopause symptoms
ICD-10 code
N95.1, N95
ICD-10 code description
Menopausal and female climacteric states, Other specified menopausal and perimenopausal disorders
2
Description of health condition studied
Quality of life
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Total and subdomains scores of early menopause symptoms
Timepoint
Before intervention, 8 and 12 weeks after intervention
Method of measurement
Greene scale
2
Description
Total and subdomains scores of quality of life
Timepoint
Before interventions, 8 and 12 weeks after intervention
Method of measurement
Menopause specific quality of life (MENQOL) questionnaire
Secondary outcomes
1
Description
Frequency of hot flashes
Timepoint
Before interventions, 8 and 12 weeks after intervention
Method of measurement
Daily counts
Intervention groups
1
Description
The third group will receive both exercise intervention program and nutritional education.
Category
Lifestyle
2
Description
The control group will not receive the intervention.
Category
Lifestyle
3
Description
The first group will receive exercise intervention program. Exercise program includes walking sessions for 30 to 45 minutes, three times per week for 12 weeks with 60 to 70% of heart rate reserve, under direct supervision of a person from research team. Their heart rate will be measured using a Polar pulse meter.
Category
Lifestyle
4
Description
The second group will receive nutrition education. Nutrition education includes three educational sessions; about 45 to 60 minutes lecture and group discussion; held for groups of 10 to 17 persons for three consecutive weeks. At the end of the first session, a booklet will be given to reinforce the education.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fatemi health center
Full name of responsible person
Asghari Mehrnaz
Street address
Emam street, Kaleibar
City
Kaleibar
2
Recruitment center
Name of recruitment center
Shahid Pormorad health center
Full name of responsible person
Asghari Mehrnaz
Street address
Moallem street, kaleibar
City
kaleibar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Shakouri Seyyed Kazem
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Asghari Mehrnaz
Position
Master in midwifery
Other areas of specialty/work
Street address
Tarbiat Street, Kaleibar
City
Kaleibar
Postal code
5461835938
Phone
+98 42 7422 4216
Fax
+98 42 7422 3574
Email
m.asghari1355@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
347-51745
Phone
+98 41 1479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)