Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000055909
Ethics application status
Approved
Date submitted
14/01/2011
Date registered
17/01/2011
Date last updated
17/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Variability and Heart Rate Kinetics During the Six-Minute Walk Test in Morbidly Obese Women – Effect of Aerobic Exercise Training after Gastric Bypass Surgery
Scientific title
Variability and Heart Rate Kinetics During the Six-Minute Walk Test in Morbidly Obese Women – Effect of Aerobic Exercise Training after Gastric Bypass Surgery
Secondary ID [1] 253409 0
no secondary IDs
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obese women undergoing aerobic exercise after gastric bypass surgery 260961 0
Condition category
Condition code
Diet and Nutrition 259096 259096 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will undergo a clinical examination prior to the gastric bypass surgery (GBS) Roux-en-Y, which will be done by gastroenterologist and a cardiologist physician (anamnesis, resting 12-lead electrocardiogram, endoscopy and blood analysis used to determine hemoglobin, triglycerides, total cholesterol and fractions: low-density lipoprotein - LDL and high-density lipoprotein - HDL, fasting glucose and uric acid). In addition, anthropometric data, spirometric measurements, regular physical activity pattern, record of heart rate (HR) and R-R intervals during six-minute walk test (6MWT) will be collected 1 week before and 4 months after GBS. One month after surgery, the obese women will be randomly assigned to two groups: 1) trained (that will participate in a aerobic exercise training program for 3 months) and 2) untrained (will not participate in the exercise program).
The aerobic exercise training program consist of five steps: 1) initial five minutes of stretching the upper and lower limbs (hamstrings, quadriceps, calves, shoulders) and diaphragmatic breathing and awareness of proper posture in front of a mirror in the position standing and sitting;
2) five minutes of heating on a treadmill at 3 km/h;
3) forty minutes of walking on treadmill with speed and inclination varying according to the behavior of HR. These forty minutes will be separated into four steps of 10 minutes each: 1 degree) intensity of exercise which the HR remained at 50% of HR maximal; 2 degrees) 60% of HR maximal; 3 degrees) 70% of HR maximal and 4 degrees) maintaining 70% of HR maximal; Note: Heart rate and blood pressure will be obtained at the end of each step;
4) recovery of one minute at 3 km/h and;
5) last step of ten minutes of the same initial stretching and diaphragmatic breathing.
HR and blood pressure will be obtained at the beginning of the session, at the end of each step, recovery and at the end of session. The sessions will be held during one hour on alternate days: 3 times per week, for 12 weeks, a total of 36 sessions, a period of 3 months. The sessions will be performed individually and supervisioned by physiotherapist.
The control group (eutrophic healthy women), will not perform the GBS and will not participate in the exercise program
Intervention code [1] 257859 0
Rehabilitation
Intervention code [2] 257860 0
Treatment: Other
Comparator / control treatment
The group of eutrophic healthy women (that had not been previously submitted to bariatric surgery) will performe all the assessments (anthropometric data, spirometric measurements, regular physical activity pattern, record of HR and R-R intervals during 6MWT) and will be considered the control group, because , however, they do not carry out any intervention (will not perform the GBS and will not participate in the exercise program)
Control group
Active

Outcomes
Primary outcome [1] 261949 0
The six-minute walk test will be performed to assess the heart rate kinetics and heart rate variability
Timepoint [1] 261949 0
In the obese group: 1 week before and 4 months after gastric bypass surgery.

In the control group: performed the same evaluation, only one time
Secondary outcome [1] 268862 0
The heart rate and R-R interval will be measured using an cardiofrequencimeter
Timepoint [1] 268862 0
In the obese group: 1 week before and 4 months after gastric bypass surgery during the six-minute walk test.

In the control group: performed the same evaluation, only one time

Eligibility
Key inclusion criteria
Inclusion criteria wiil be: (1) obese group: BMI = 40 kg/m2 for more than 5 years who will undergoa Roux-en-Y GBS, (2) control group (CG): 18.5 < BMI < 24.9 Kg/m2, (3) sedentary lifestyle and (4) age from 20 to 45 years old.
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) women with orthopedic or neurological conditions that would preclude participation in an exercise program, (2) a history of cardiac arrhythmias or potential ECG alterations, (3) past history consistent with heart disease, (4) uncontrolled hypertension and diabetes mellitus, (5) chronic obstructive pulmonary disease (evaluated by previous pulmonary function measurements), (6) beta-blocker use, (7) postmenopausal status and, (8) participation in a regular exercise program at the time of study enrollment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
One month after GBS, the obese group was randomized by using sequentially-numbered, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment outside Australia
Country [1] 3140 0
Brazil
State/province [1] 3140 0
Sao Paulo
Country [2] 3141 0
Brazil
State/province [2] 3141 0
Sao Carlos

Funding & Sponsors
Funding source category [1] 258325 0
University
Name [1] 258325 0
Universidade Federal de Sao Carlos
Country [1] 258325 0
Brazil
Primary sponsor type
Individual
Name
Viviane Castello
Address
Laboratorio de Fisioterapia Cardiorrespiratoria, Nucleo de Pesquisa em Exercicio Fisico (NUPEF), Rodovia Washington Luis (SP-310), km 235, Sao Carlos - Sao Paulo. CEP 13565-905.
Country
Brazil
Secondary sponsor category [1] 257484 0
Individual
Name [1] 257484 0
Rodrigo Polaquini Simoes
Address [1] 257484 0
Laboratorio de Fisioterapia Cardiorrespiratoria, Nucleo de Pesquisa em Exercicio Fisico (NUPEF), Rodovia Washington Luis (SP-310), km 235, Sao Carlos - Sao Paulo. CEP 13565-905.
Country [1] 257484 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260303 0
Ethics Committee of Federal University of Sao Carlos
Ethics committee address [1] 260303 0
Rodovia Washington Luis (SP-310), km 235, Sao Carlos - Sao Paulo. CEP 13565-905.
Ethics committee country [1] 260303 0
Brazil
Date submitted for ethics approval [1] 260303 0
Approval date [1] 260303 0
Ethics approval number [1] 260303 0

Summary
Brief summary
the purpose of this study will be (1) evaluate whether morbidly obese women have alteration of responses of heart rate (HR) kinetics during transition from resting to six-minute walk test (6MWT) and alteration in the HR variability during this test when compared with eutrophic women; (2) to determine if 4 months after gastric bypass surgery improves the HR kinetics and the cardiac modulation during the 6MWT and (3) determine the impact of an aerobic exercise training program (12 weeks) after GBS on HR kinetics and cardiac autonomic modulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32093 0
Address 32093 0
Country 32093 0
Phone 32093 0
Fax 32093 0
Email 32093 0
Contact person for public queries
Name 15340 0
Viviane Castello
Address 15340 0
Laboratorio de Fisioterapia Cardiorrespiratoria, Nucleo de Pesquisa em Exercicio Fisico (NUPEF), Rodovia Washington Luis (SP-310), km 235, Sao Carlos - Sao Paulo. CEP 13565-905.
Country 15340 0
Brazil
Phone 15340 0
(+55 16) 3351-8705
Fax 15340 0
(+55 16) 3361-2081
Email 15340 0
[email protected]
Contact person for scientific queries
Name 6268 0
Rodrigo Polaquini Simoes
Address 6268 0
Laboratorio de Fisioterapia Cardiorrespiratoria, Nucleo de Pesquisa em Exercicio Fisico (NUPEF), Rodovia Washington Luis (SP-310), km 235, Sao Carlos - Sao Paulo. CEP 13565-905.
Country 6268 0
Brazil
Phone 6268 0
(+55 16) 3351-8705
Fax 6268 0
(+55 16) 3361-2081
Email 6268 0
[email protected]

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