Effect of 12 Weeks Aerobic Exercise and Combination of Aerobic-Resistance Exercise on anthropometric Indices and Functional Capacity in obese Patients after Bariatric Surgery
The study is an interventional trial to investigate the effects of 12 weeks exercise on anthropometric indices and functional capacity of obese patients after bariatric surgery. Sixthly patients with body mass index equal to or greater than 35 will be included in the trial. The patients will be allocated randomly in the aerobic or aerobic-resistance exercise groups or in the control group. After inclusion of the participants, all of them will receive the standard diet (600-800 Kcal for the first 4-weeks, 800 Kcal for the second 4-weeks and 1000-12000 Kcal for the third 4-weeks) with high protein formula. Outcomes including anthropometric changes and functional aerobic-resistance capacity improvement will be assessed in the beginning of the trial (pre-surgery) and after 12 weeks of the bariatric surgery. Anthropometric measurements include weight, high, body mass index and body composition analysis. The functional capacity includes 12-minute walk run test, chest press and squat. The measurements and data analysis will be applied by blinded educated persons.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512297903N7
Registration date:2016-01-15, 1394/10/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-15, 1394/10/25
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
z_alizadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 12 Weeks Aerobic Exercise and Combination of Aerobic-Resistance Exercise on anthropometric Indices and Functional Capacity in obese Patients after Bariatric Surgery
Public title
The effect of bariatric surgery along with exercise on weight reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: body mass index greater than 35, bariatric surgery, age between 20 to 50 years, without history of metabolic or cardiovascular or musculoskeletal disease,
Exclusion: pregnancy during the trial, musculoskeletal problems, taking drugs with effect on appetite or weight.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
The Center of Tehran University of Medical Sciences,Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.TUMS.REC.1394.1434
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
(E65, E66,
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Weight reduction
Timepoint
3 month
Method of measurement
Anthropometery and body composition analysis
Secondary outcomes
1
Description
Aerobic and resistance functional capacity
Timepoint
3 month
Method of measurement
12 minute walk-run aerobic test, 1 repetittion maximal test
Intervention groups
1
Description
surgery, diet and aerobic or aerobic-resistance exercise in the intervention groups during 3 months
Category
Treatment - Other
2
Description
surgery and diet in the control group during 3 month
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Mostafa Khomeini Hospital
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Khataam Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Miss Khalilpour
Street address
4th Floor, The Center of Tehran University of Medical Sciences, Ghods St., 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
Vice chancellor for research, 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
No7, Opposite of Shariati Hospital, Ale-Ahmad Highway, Tehran
City
Tehran
Postal code
Phone
+98 21886302278
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
7
City
No7, Opposite of Shariati Hospital, Ale-Ahmad Highway, Tehran
Postal code
Phone
+98 21886302278
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
No7, Opposite of Shariati Hospital, Ale-Ahmad Highway, Tehran
City
Tehran
Postal code
Phone
+98 21886302278
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)