The study goal is comparing the effectiveness of home-based aerobic and resistance exercise training versus supervised aerobic or strength training on physical fitness, weight loss and muscle mass in obese patients after Bariatric surgery. This study includes 90 patients who had Bariatric surgery 6 weeks ago. The evaluation includes medical history and physical examination, measurement of weight and height to calculate body mass index .Then patients will undergo the 6-minute walking test to determine physical fitness. We evaluate fatigue and shortness of breath based on Borg Scale questionnaire and muscle strength by Dynamo meter. Then Patients will be randomized to 3 different groups: Group 1 includes 30 patients who will receive conventional therapy including sessions how to do aerobic and resistance exercise, supplemental handbook as a reminder for exercises they are supposed to do as well as a pedometer to keep track of their physical activity . Group 2 includes 30 patients who will receive conventional therapy plus 2 sessions of strength training per week each for an hour under supervision of a Sports Medicine physician. Group 3 Includes 30 patients who will receive 2 hourly sessions of aerobic exercise per week supervised by a sport medicine specialist in addition to conventional therapy. At the end of the 3 months we will re-measure all parameters and compare them to the initial values to find out if our interventions by using supervised training make a difference between the values of 3 different groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111064251N6
Registration date:2011-12-29, 1390/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-29, 1390/10/08
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
halehd@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical sciences
Expected recruitment start date
2011-08-06, 1390/05/15
Expected recruitment end date
2012-08-05, 1391/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of home base exercise versus supervised exercise therapy on weight loss, fitness and muscle mass in patients undergoing Bariatric surgery
Public title
The effect of home base exercise versus supervised exercise therapy on weight loss, fitness and muscle mass in patients undergoing Bariatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with Bariatric Surgery in 1-3 months ago. Exclusion criteria: 1. Those with heart disease may include: heart valve disease , ischemic heart disease , uncontrolled symptomatic arrhythmia , hypertrophic cardiomyopathy; 2.Patients with high systolic blood pressure ≥ 200 and high diastolic blood pressure ≥90; 3. Uncontrolled metabolic diseases; 4. Neuromuscular, musculoskeletal and rheumatoid disease that Resonance with exercise; 5. Acute pulmonary embolism; 6. Symptomatic chronic heart failure.
Age
From 15 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethics comitte of Tehran University of Medical Sciences
Street address
Ghods street, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2011-11-19, 1390/08/28
Ethics committee reference number
130.1764/ص/90
Health conditions studied
1
Description of health condition studied
weight loss in morbid obese patients
ICD-10 code
E66.8
ICD-10 code description
Morbid obesity
Primary outcomes
1
Description
Body mass index
Timepoint
6 weeks after bariatric surgery and 4.5 months after surgery
Method of measurement
BMI = ( Weight in Kilograms / ( Height in Meters x Height in Meters
2
Description
physical fitness
Timepoint
6 weeks after bariatric surgery and 4.5 months after surgery
Method of measurement
6-minute walk test
3
Description
Muscle mass
Timepoint
6 weeks after bariatric surgery and 4.5 months after surgery
Method of measurement
Bioelectrical impedance analysis
4
Description
muscle strength
Timepoint
6 weeks after bariatric surgery and 4.5 months after surgery
Method of measurement
hand daynamo meter
5
Description
Exertional dyspnea
Timepoint
6 weeks after bariatric surgery and 4.5 months after surgery
Method of measurement
Borg scale questionnaire
Secondary outcomes
1
Description
waist circumference
Timepoint
6 weeks after bariatric surgery and 4.5 months after surgery
Method of measurement
in centimeters by Tape
2
Description
Heart rate
Timepoint
6 weeks after bariatric surgery and 4.5 months after surgery
Method of measurement
Stethoscope
3
Description
weight
Timepoint
6 weeks after bariatric surgery and 4.5 months after surgery
Method of measurement
in kilograms by Balance
Intervention groups
1
Description
Group 1: includes 30 patients who will receive conventional therapy including session of how to do aerobic and resistance exercise, supplemental handbook as a reminder for exercises they are supposed to do as well as a pedometer to keep track of their physical activity.
Category
Lifestyle
2
Description
Group 2: includes 30 patients who will receive conventional therapy plus 2 sessions of strength training per week each for an hour under supervision of a Sports Medicine physician
Category
Lifestyle
3
Description
Group 3: Includes 30 patients who will receive 2 hourly sessions of aerobic exercise per week supervised by a sport medicine specialist in addition to conventional therapy.