Evaluation of the effect of yoga on cognitive functions in women with HIV
Design
In this single-blind clinical trial, 44 HIV patients will be assigned into parallel groups using the random blocks method.
Settings and conduct
The study population consists of HIV-infected women undergoing treatment at Behavioral Disease Counseling Center, Hamadan, Iran. In this single-blind study, the person responsible for data collection is blind to the type of treatment in participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Not participating in similar fitness activities.
Exclusion criteria: Inability to perform respiratory, physical, and relaxation exercises; moderate to severe hepatic disorder; cardiovascular diseases; drug abuse; not doing regular exercise.
Intervention groups
The control group will not receive special training in addition to the routine treatment. The intervention group will receive yoga exercises, along with the treatment, consisting of two 1-hour sessions per week under the supervision of yoga teachers, one 1-hour session at home, and 15-minute relaxation exercises at the end of each session for 8 weeks.
Main outcome variables
Evaluation and comparison of cognitive functions between intervention and control group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191216045756N1
Registration date:2020-01-19, 1398/10/29
Registration timing:prospective
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Shahla Adelkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3837 1164
Email address
adelkhanis@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-09-18, 1399/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial investigating the effect of yoga on cognitive functions in women with HIV
Public title
Effect of yoga on cognitive functions in HIV patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not participating in similar fitness activities
Exclusion criteria:
Inability to perform respiratory, physical, and relaxation exercises
Moderate to severe hepatic disorder
Cardiovascular diseases
Drug abuse
Not doing regular exercise
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into two groups of 22 patients with blocks of 2 and 4 using the randomization method. A noninvolved researcher will determine the random allocation sequencing in sample selection using a the SAS software. Sequentially numbered sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants will be given codes and assigned into the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study population consists of HIV-infected women undergoing treatment at Behavioral Disease Counseling Center, Hamadan, Iran. In this single-blind study, the person responsible for data collection is blind to the type of treatment in participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Vice Chancellor for Research, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2019-12-12, 1398/09/21
Ethics committee reference number
IR.UMSHA.REC.1398.758
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B20.0
ICD-10 code description
HIV disease resulting in mycobacterial infection
Primary outcomes
1
Description
Cognitive functions
Timepoint
Before and after the intervention
Method of measurement
Based on quantitative electroencephalography (QEEG)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive yoga exercises, along with the treatment, consisting of two 1-hour sessions per week under the supervision of yoga teachers, one 1-hour session at home, and 15-minute relaxation exercises at the end of each session for 8 weeks.
Category
Other
2
Description
Control group: The control group will not receive special training in addition to the routine treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Behavioral Counseling Center
Full name of responsible person
Shahla Adelkhani
Street address
Beginning at Takhti Street, Martyrs Health Center
City
Hamadan
Province
Hamadan
Postal code
6517838654
Phone
+98 81 3252 1411
Fax
Email
Hamedan_health@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Vice Chancellor for Research, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3448 1000
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Islamic Azad University
Full name of responsible person
Shahla Adelkhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Islamic Azad University of Hamadan, Prof. Mousivand Blvd, Imam Khomeini Blvd
City
Hamedan
Province
Hamadan
Postal code
4816633131
Phone
+98 81 3448 1000
Email
adelkhanis@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahla Adelkhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Islamic Azad University of Hamadan, Prof. Mousivand Blvd, Imam Khomeini Blvd
City
Hamedan
Province
Hamadan
Postal code
4816633131
Phone
+98 81 3448 1000
Email
adelkhanis@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahla Adelkhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Islamic Azad University of Hamadan, Prof. Mousivand Blvd, Imam Khomeini Blvd
City
Hamedan
Province
Hamadan
Postal code
4816633131
Phone
+98 81 3448 1000
Email
adelkhanis@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Shahla Adelkhani provides the analysis code to the applicants via email: adelkhanis@yahoo.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.