The Impact of Four Months Resistance Training and Recreational Sport Activities on CD4 Level, Body Composition and Psychological Health among HIV Infected Men in Tehran Positive Club
The main goal of this project is to study effects of four months resistance training and recreational sport activities on CD4 level, quality of life, quality of sleep, anxiety and depression, clinical symptoms and body composition among HIV infected men. These group will be compare with the group of HIV infected men in control group without any physical activities during 4 months. Participants consist of 45 HIV positive men (with inclusion criteria include: being between 18 to 45 years old; don’t be on highly active antiretroviral therapy or do not take any antiretroviral treatment at least in last six months; do not be actively addicted to any drug; be cooperative in this study and follow ups; do not have physical exercises in last six months) and will be exclude from the study if they take psychological drugs in order to treatment of anxiety and depression; has unstable condition regarding HIV infection status; has exacerbation in health condition during the study in a way that he could not do physical exercises.
HIV positive men will be divided in three groups randomly which are mentioned below; men who will do resistance training for 4 months (15 participants); men who will do recreational sport activities for 4 months (15 participants); men who will do no physical activities for 4 months (15 participants).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604034076N18
Registration date:2016-05-05, 1395/02/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Four Months Resistance Training and Recreational Sport Activities on CD4 Level, Body Composition and Psychological Health among HIV Infected Men in Tehran Positive Club
Public title
The Impact of Resistance Training and Recreational Sport Activities on CD4 Level, Body composition and Psychological Health among HIV Infected Men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Be between 18 to 45 years old; don’t be on highly active antiretroviral therapy or do not take any antiretroviral treatment at least in last six months; do not be actively addicted to any drug; be cooperative in this study and follow ups; do not have physical exercises in last six months.
Exclusion criteria: Takes psychological drugs; has unstable condition regarding HIV infection status; has exacerbation in health condition during the study in a way that he could not do physical exercises
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central building of TUMS, Ghods St, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
IR.TUMS.REC.1395.2348
Health conditions studied
1
Description of health condition studied
HIV/AIDS
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
Primary outcomes
1
Description
CD4 level
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Laboratory tests
Secondary outcomes
1
Description
Sleep quality
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Sleep Quality questionnaire (PSQI)
2
Description
Anxiety and depression
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Anxiety and Depression questionnaire (HAD)
3
Description
Body composition
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Body composition device
4
Description
Quality of life
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Quality of life questionnaire (SF-36)
5
Description
Clinical symptoms
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Clinical symptoms checklist (MSCL & SCL90-R)
Intervention groups
1
Description
Intervention group: In this clinical trial, after getting consent of participants, we will conduct interviews based on questionnaires and following by that body composition of participants will be measured by body composition machine. These participants will be divided in three groups randomly. People in first group with resistance training, will do exercises with emphasis on big muscles three times a week for four months. The other group with recreational sport activities will do activities such as Ping-Pong, foosball and throwing darts three times a week based on their interests.
At the end of four months, all the participants in three groups will be assessed body composition, CD4 level and Psychological Health.
Category
Other
2
Description
Control group: In this group no intervention will be made.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran positive club
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Resaerch Deputy of Tehran University of Medical Sciences
Full name of responsible person
Dr Younesian
Street address
Ghods Avn, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Resaerch Deputy of Tehran 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
Iranian Research Center for HIV/AIDS (IRCHA)
Full name of responsible person
Dr Minoo Mohraz
Position
Head of IRCHA
Other areas of specialty/work
Street address
Iranian Research Center for HIV/AIDS (IRCHA), Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6694 7984
Fax
Email
ircha@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Research Center for HIV/AIDS
Full name of responsible person
Dr Minoo Mohraz
Position
Professor
Other areas of specialty/work
Street address
Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6658 1583
Fax
Email
ircha@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian Research Center for HIV/AIDS
Full name of responsible person
Farzaneh Vakil Ghahani
Position
Msc
Other areas of specialty/work
Street address
Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)