Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000406000
Ethics application status
Approved
Date submitted
18/05/2010
Date registered
20/05/2010
Date last updated
17/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of aerobic exercise training on heart rate variability and functional capacity in obese women after gastric bypass surgery
Scientific title
Impact of aerobic exercise training on heart rate variability and functional capacity in obese women after gastric bypass surgery
Secondary ID [1] 251787 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 257386 0
Condition category
Condition code
Diet and Nutrition 257543 257543 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will undergo a clinical examination prior to the surgery, 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, six-minute walk test (6MWT) and R-R intervals will be collected before and 4 months after gastric bypass surgery.
One month after surgery, patients will be randomly assigned to two groups: 1) control and 2) physical training. The aerobic exercise training program consist of: 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 heart rate (HR). These forty minutes will be separated into four steps of 10 minutes each: 1 degree) intensity of exercise in 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; 4) recovery of one minute at 3 km/h and; 5) 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.
Intervention code [1] 256495 0
Rehabilitation
Intervention code [2] 256520 0
Treatment: Other
Comparator / control treatment
The control group will be submitted to clinical examination (anamnesis, resting 12-lead electrocardiogram, endoscopy, blood analysis, anthropometric data, spirometric measurements, regular physical activity pattern, six-minute walk test and R-R intervals), without participating in the program of physical training after surgery.
Control group
Active

Outcomes
Primary outcome [1] 258444 0
The heart rate and R-R interval will be measured using an cardiofrequencimeter
Timepoint [1] 258444 0
1 week before and 4 months after gastric bypass surgery in the rest (supine position).
Secondary outcome [1] 264231 0
The six-minute walk test will be performed to assess the walking distance
Timepoint [1] 264231 0
1 week before and 4 months after gastric bypass surgery in the rest (supine position).

Eligibility
Key inclusion criteria
Will be included in the study women with morbid obesity (body mass index greater than or equal to 40 kg/m2) for more than 5 years, aged between 20 and 45 years and that will be submitted to gastric bypass surgery.
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) patients with orthopedic or neurological conditions that would preclude participation in an exercise program, 2) recent myocardial infarction (6 months), 3) implanted pacemaker, 4) unstable angina, 5) chronic disturbances in heart rhythm, 6) significant acute arrhythmias, 7) valvular heart disease, 8) a past history consistent with heart disease, 9) uncontrolled hypertension and diabetes mellitus, 10) concomitant surgery, 11) chronic obstructive pulmonary disease, 12) beta-blocker use 13) postmenopausal women and 14) physically active women.

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)
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
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
10/06/2010
Date of last participant enrolment
Anticipated
Actual
10/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2631 0
Brazil
State/province [1] 2631 0
Sao Paulo/Sao Carlos

Funding & Sponsors
Funding source category [1] 256983 0
University
Name [1] 256983 0
Universidade Federal de Sao Carlos
Country [1] 256983 0
Brazil
Primary sponsor type
Individual
Name
Audrey Borghi e Silva
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] 256244 0
Individual
Name [1] 256244 0
Viviane Castello
Address [1] 256244 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] 256244 0
Brazil
Other collaborator category [1] 1259 0
Individual
Name [1] 1259 0
Rodrigo Polaquini Simoes
Address [1] 1259 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] 1259 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258992 0
Ethics Committee of Federal University of Sao Carlos
Ethics committee address [1] 258992 0
Ethics committee country [1] 258992 0
Brazil
Date submitted for ethics approval [1] 258992 0
Approval date [1] 258992 0
Ethics approval number [1] 258992 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31174 0
A/Prof Audrey Borghi e Silva
Address 31174 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 31174 0
Brazil
Phone 31174 0
+551633518705
Fax 31174 0
No fax number
Email 31174 0
[email protected]
Contact person for public queries
Name 14421 0
Viviane Castello
Address 14421 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 14421 0
Brazil
Phone 14421 0
(+55 16) 3351-8705
Fax 14421 0
Email 14421 0
[email protected]
Contact person for scientific queries
Name 5349 0
Viviane Castello
Address 5349 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 5349 0
Brazil
Phone 5349 0
(+55 16) 3351-8705
Fax 5349 0
Email 5349 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.