Protocol summary

Study aim
effects of hatha yoga on anthropometric and psychological indices among retired women.
Design
This randomized controlled trial was conducted on 64 female retirees of Rafsanjan University of Medical Sciences, Rafsanjan, Iran. The samples were randomly divided into intervention and control groups.
Settings and conduct
The sessions of the program were held thrice weekly in a yoga club in Rafsanjan, Iran. Anthropometric indices, depression, anxiety, and stress were measured before, one month, and two months after the intervention onset.
Participants/Inclusion and exclusion criteria
Participants include 64 retired women from the University of Medical Sciences. no history of advanced osteoporosis, hip replacement, gradual blindness, gradual loss of vision, Parkinson’s disease, dizziness, surgery, no special diet, no use of weight-loss medications, and no history of significant loss or acute psychiatric disorder in the past six months. The only exclusion criterion was three or more absences from yoga sessions.
Intervention groups
Participants were randomly recruited and allocated to either a control or an intervention group. Participants in the intervention group were provided with an eight-week yoga program, while their counterparts in the control group received no exercise-based intervention.
Main outcome variables
depression, anxiety, and stress,weight, height, BMI, waist circumference, hip circumference, wais to hip ratio, and wrist circumference.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150519022320N19
Registration date: 2019-01-27, 1397/11/07
Registration timing: retrospective

Last update: 2019-01-27, 1397/11/07
Update count: 0
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-20, 1395/03/31
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
2016-06-20, 1395/03/31
Actual recruitment end date
2016-08-21, 1395/05/31
Trial completion date
2016-08-21, 1395/05/31
Scientific title
The effects of hatha yoga on anthropometric and psychological indices among the retired women
Public title
The effects of hatha yoga on anthropometric and psychological indices
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
the people that they did not have history of improvement Steoprusis during last year no history of significant loss or acute psychiatric disorder in the past six months people that they did not have history of hip replacing people that they did not have history of gradational blindness people that they did not have history of Parkinson people that they did not have history of surgery
Exclusion criteria:
Do not participate more than 4 exercise session Physical injury during the exercise
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: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
From eligible women, 64 were randomly recruited to the study and randomly allocated to an A and a B group using a table of random numbers. Then, groups A and B were randomly allocated to either the control or the intervention side of the study.
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 Rafsanjan University ofMedical Sciences
Street address
Emamali Blv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.RUMS.RES.1394.238

Health conditions studied

1

Description of health condition studied
Anthropometric indices
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Psychological indices
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
depression, which was measured using the DASS-21 scale.
Timepoint
Before the start of the study, one month after the start of the intervention, two months after the intervention begins
Method of measurement
Depression, Anxiety, and Stress Scale (DASS-21)

2

Description
Anxiety, which was measured using the DASS-21 scale.
Timepoint
Before the start of the study, one month after the start of the intervention, two months after the intervention begins
Method of measurement
Depression, Anxiety, and Stress Scale (DASS-21)

3

Description
Stress, which was measured using the DASS-21 scale.
Timepoint
Before the start of the study, one month after the start of the intervention, two months after the intervention begins
Method of measurement
Depression, Anxiety, and Stress Scale (DASS-21)

4

Description
body mass index
Timepoint
Before the start of the study, one month after the start of the intervention, two months after the intervention begins
Method of measurement
By dividing weight in kilograms by the square of height in meters measured.

5

Description
Waist circumference
Timepoint
Before the start of the study, one month after the start of the intervention, two months after the intervention begins
Method of measurement
Waist circumference was measured in the midway between the inferior rib and the iliac crest at the end of expiration

6

Description
hip circumference
Timepoint
Before the start of the study, one month after the start of the intervention, two months after the intervention begins
Method of measurement
hip circumference was measured at the widest point of the greater trochanter muscle.

7

Description
Waist-hip ratio
Timepoint
Before the start of the study, one month after the start of the intervention, two months after the intervention begins
Method of measurement
Waist-hip ratio was calculated through dividing waist circumference by hip circumference.

8

Description
wrist circumference
Timepoint
Before the start of the study, one month after the start of the intervention, two months after the intervention begins
Method of measurement
wrist circumference was measured at the junction point between wrist and the metacarpal bones.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group was subjected to Hatha yoga exercises for 8 weeks with three 1-hour sessions in each week.
Category
Rehabilitation

2

Description
Control group: No intervention for the control group was performed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
RetiredCenter Of Rafsanjan MedicalScience Univeacity
Full name of responsible person
Dr Tayyebe Mirzaei
Street address
Jomhory street, Parastar blv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Alishamce zadeh
Street address
Emamali Blv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.mirzaie@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayyebeh Mirzaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing,Nurse blv, Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayyebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing,Nurse blv, Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohadaseh Raeisi
Position
Non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Parastar blv, Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
mraesi@ymail.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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