The aim of this study is to investigate the effectiveness of six_month concurrent training on inflammatory markers,growth factors and bone mineral density of HIV positive patients
Design
Current study is a clinical trial with parallel group design and 30 eligible persons will randomly assign to one of intervention (15)and control group(15)
Settings and conduct
location of conducting current project is Tehran Positive Club situated in Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
1- Between 18-60 years old
2-Do not having active addiction
3-Being interest for participation in study
4-Being under stable anti retro viral therapy for previous six months
5-ِDid not have regular exercise training in previous six months
6-hve stable ART in previous six months
7-Do not have situations that susceptible participants to bone loss .
Intervention groups
The participants in the intervention group for six months performing concurrent training.and we will asking from participants in the control group to maintain their levels of physical activity during study period.
Main outcome variables
Bone Mineral Density(BMD)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100601004076N21
Registration date:2018-04-04, 1397/01/15
Registration timing:registered_while_recruiting
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
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
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-05-23, 1397/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of six months concurrent training effects on inflammatory markers, growth factors and bone mineral density of HIV positive patients
Public title
Exercise therapy for HIV+ patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-60 years old
Do not have active addiction at the initiation of study
having interest to participate in study
Being under stable anti retro-viral therapy for previous six month
Exclusion criteria:
using drugs that have affect on bone mineral density
participate in regular exercise training in previous six months
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible volunteers will randomly be assigned to intervention and control groups. randomization will be done by a randomization list that will be generated by computerized software program
Blinding (investigator's opinion)
Not blinded
Blinding description
Due to nature of this study it is not possible to blind participants and researchers to benefits of intervention
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Tehran University of Medical Sciences
Street address
Central building of TUMS, Ghods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
0123456789
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1863
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus [HIV] disease
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Bone Mineral Density(BMD)
Timepoint
pre and post study period
Method of measurement
Dual-energy X-ray absorptiometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants in the intervention group will participate in concurrent training for six months and three times a week. concurrent training involves a combination of aerobic training and resistance training, resistance training with an emphasis on the large muscles groups . In order to maintain the overload, the training variables such as the intensity and volume of exercise, resistance training and aerobic training manipulate according to patient progression. To maintain the principle of overload.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran positive club
Full name of responsible person
Nasrin Kordi
Street address
Tehran positive club,Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6658 1583
Email
ircha@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Younesian
Street address
Ghods Avn, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
0123456789
Phone
+98 21 6641 9661
Email
assafh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Minoo Mohraz
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Iranian Research Center for HIV/AIDS (IRCHA), Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1956865432
Phone
+98 21 6694 7984
Email
ircha@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Ghayomzadeh
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
iranian research center for HIV/AIDS,Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1123565479
Phone
+98 21 6658 1583
Email
morteza_ghayomzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Ghayomzadeh
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6694 7984
Email
morteza_ghayomzadeh@yahoo.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