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The effect of yoga exercise on anxiety, depression, sleep quality and memory of elderly women at Adult Day Care Centers

Protocol summary

Study aim
The effect of yoga exercise on anxiety, depression, sleep quality and memory of elderly women Adult day centers in Yazd
Design
This study is a clinical trial.From the Adult Day Care Centers in Yazd, two centers are randomly selected, one is assigned as a test group and the other is assigned as a control group.Community-based and action-oriented, with parallel groups, not blind
Settings and conduct
Research in adult day centers are in Yazd. In the intervention group, yoga exercises are held for 8 weeks and each week in three 1-hour sessions. In the control and intervention groups, the anxiety, depression, DASS depression, Pittsburgh sleep quality and Wechsler memory are completed before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: were age over 60 years old, no physical problems such as hip replacement, Parkinson’s disease, and dizziness leading to inabilities to practice the exercises, signing consent forms to participate in the study, and obtaining permission from a trusted physician to practice the yoga poses. Exclusion Criteria: Lack of cooperation, cognitive problems (Alzheimer’s disease, progressive physical and mental problems during practice, sensorineural hearing loss (deafness), neurodevelopmental disorder (mental retardation), absenteeism in more than 3 sessions of exercises, no consumption of sleeping pills over the last one month, and movement from the adult day care center
Intervention groups
Intervention group: As a group, by experienced educators, for 8 weeks, three sessions of one hour a week doing yoga. Before intervention and after intervention, anxiety, depression, sleep quality and memory of the samples will be investigated. Control group: In this study, no intervention was performed for the control group.
Main outcome variables
The mean score of anxiety, depression, sleep quality and memory

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190103042225N1
Registration date: 2019-01-14, 1397/10/24
Registration timing: registered_while_recruiting

Last update: 2019-01-14, 1397/10/24
Update count: 0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Sanaz Behzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3624 9939
Email address
sanaz24behzadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga exercise on anxiety, depression, sleep quality and memory of elderly women at Adult Day Care Centers
Public title
The effect of yoga exercise on anxiety, depression, sleep quality and memory
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
were age over 60 years old, no physical problems such as hip replacement, Parkinson’s disease, and dizziness leading to inabilities to practice the exercises, signing consent forms to participate in the study, and obtaining permission from a trusted physician to practice the yoga poses.
Exclusion criteria:
Lack of cooperation, cognitive problems (Alzheimer’s disease, progressive physical and mental problems during practice, sensorineural hearing loss (deafness), neurodevelopmental disorder (mental retardation), absenteeism in more than 3 sessions of exercises, no consumption of sleeping pills over the last one month, and movement from the adult day care center
Age
From 60 years old to 89 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 58
Actual sample size reached: 58
Randomization (investigator's opinion)
Randomized
Randomization description
From the Adult Day Care Centers in Yazd, two centers are randomly selected, one is assigned as a test group and the other is assigned as a control group.Then, due to the low level of elderly covered by each center, all elderly people are covered by the control and test groups covered by each entry-level criteria.The random method will be in the form of a draw, in this way, for each of the code centers, then the codes are written on a piece of paper. The pieces of paper are placed in a container and they are thrown well. Then two centers are selected from among them.
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
Shahid Sadoughi University of Medical Sciences Yazd
Street address
Yazd, Shahid Bahonar Square, Central Office of Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IR.SSU.SPH.REC.1396.45

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

2

Description of health condition studied
depression
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode

3

Description of health condition studied
sleep quality
ICD-10 code
ICD-10 code description

4

Description of health condition studied
memory
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety scale Evaluation
Timepoint
Before the intervention and after the intervention.
Method of measurement
DASS21 questionnaire

2

Description
Depression scale Evaluation
Timepoint
Before the intervention and after the intervention.
Method of measurement
DASS21 questionnaire

3

Description
sleep quality scale Evaluation
Timepoint
Before the intervention and after the intervention.
Method of measurement
Pittsburgh Sleep Quality Questionnaire

4

Description
Memory scale Evaluation
Timepoint
Before the intervention and after the intervention.
Method of measurement
Wechsler Memory scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Performing yoga exercises for 8 weeks, three sessions per hour each week.
Category
Lifestyle

2

Description
Control group: In this study, no intervention is performed for the control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad adult day center
Full name of responsible person
Sanaz Behzadi
Street address
Alam Square, Shahid Sadoughi University of Medical Sciences, School of Public Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3624 9939
Email
sanaz24behzadi@yahoo.com

2

Recruitment center
Name of recruitment center
Bahar adult day center
Full name of responsible person
Sanaz Behzadi
Street address
Alam Square, Shahid Sadoughi University of Medical Sciences, School of Public Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3624 9939
Email
sanaz24behzadi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Vaezi
Street address
Alam Square, Shahid Sadoughi University of Medical Sciences, School of Public Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
vaeziali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sanaz Behzadi
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Alam Square, Shahid Sadoughi University of Medical Sciences, School of Public Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3624 9939
Email
sanaz24behzadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Vaezi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Alam Square, Shahid Sadoughi University of Medical Sciences, School of Public Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
vaeziali@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sanaz Behzadi
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Alam Square, Shahid Sadoughi University of Medical Sciences, School of Public Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3624 9939
Email
sanaz24behzadi@yahoo.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
No more information
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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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