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Variability and Heart Rate Kinetics During the Six-Minute Walk Test in Morbidly Obese Women – Effect of Aerobic Exercise Training after Gastric Bypass Surgery

Variability and Heart Rate Kinetics During the Six-Minute Walk Test in Morbidly Obese Women – Effect of Aerobic Exercise Training after Gastric Bypass Surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000055909
Enrollment
31
Registered
2011-01-17
Start date
2011-02-03
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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

Sponsors

Viviane Castello
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
20 Years to 45 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026