Clinical trial NCT03699683: Physical Activity Program After Bariatric Surgery
Official title: A Supervised Exercise Program After Bariatric Surgery Avoids Fat-Free Mass Loss And Reduces Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery and Physical Activity
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 38
Sex: ALL
Minimum age (years): 35
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: two groups (experimental and control) randomly assigned
Primary purpose: TREATMENT

Brief summary: Background: Bariatric surgery (BS) causes large weight reductions and improvements in cardiovascular risk (CVR), although, there are also decreases in fat-free mass (FFM). However, the effects of exercise after surgery on these variables remains to be determined.

Methods: 38 patients who underwent BS were divided into two groups: an experimental group (EG, n = 19) and a control group (CG, n = 19). Body composition, physical fitness, CVR and CVR factors were assessed in both groups one month after the surgery (T1), at 7 months (T2) and at 13 months (T3). Between T1 and T2, the EG performed a 6 month monitored aerobic and resistance combined training.

Detailed description: Forty adults that underwent BS (sleeve gastrectomy and gastric bypass) were invited to participate in the study along two years (between 1-4 patients per month). After the initial interview, two patients refused to participate in the study. The participants provided written informed consent before starting the study. The study was approved by the Ethics Committee of the University in accordance with the Declaration of Helsinki. Participants were divided into two groups (experimental, EG; and control, CG) depending on when the BS was performed. The first 10 patients of each year were the EG (n=19) and the other mine patients were the CG (n=19). A 6-month supervised and individualized program that combined aerobic and resistance training (CART) was only conducted with the EG. Both groups followed a nutritional supervision and were evaluated in 3 different time periods: Test 1 (T1), before the intervention period (approximately 1 month after BS) with no differences in any variable measured; Test 2 (T2), after the intervention period (7 months after BS) and Test 3 (T3) to evaluate a retention period (13 months after BS). The tests included in the evaluation were: blood sample, body composition, blood pressure, physical fitness (cardiorespiratory fitness, isokinetic and isometric strength measures of the lower limbs) and CVR. The test protocols were divided into 3 days: 1) between 8:00 AM and 9:00 AM., a blood sample was collected. 2) 24 hours after, at the same hour, body composition and resting blood pressure were measured. In the afternoon (between 5:00 P.M. and 8:00 P.M.), muscle strength measures were obtained. 3) at least 72 hours after the second testing session day, a cardiorespiratory fitness test was performed. Body composition, blood pressure and strength and cardiovascular tests were conducted at the facilities of the Sports Research Centre (Elche, Spain), in a climatically controlled laboratory, with a temperature between 22-24º and relative air humidity between 45-60%. Before any testing, all participants attended two familiarization sessions to introduce testing procedures and minimize the learning effects over the measures

Eligibility criteria: Inclusion Criteria:

1. Meet the age requirements
2. Be a patient of the reference hospital.
3. Follow the doctor's usual health prescriptions

Exclusion Criteria:

1. Cardiovascular diseases
2. Chronic respiratory deseases
3. Cancer in the 5 years prior to surgery
4. Severe functional limitations

Primary outcomes:
measure: Change from Baseline (T1) Total Cholesterol Blood Samples at 13 months
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.
measure: Change from Baseline (T1) HDL Cholesterol Blood Samples at 13 months
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.
measure: Change from Baseline (T1) Glucose Blood Samples at 13 months
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.
measure: Change from Baseline (T1) Triglycerides Blood Samples at 13 months
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.
measure: Change from Baseline (T1) Body composition at 13 months
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.
measure: Change from Baseline (T1) waist and hip circumference at 13 months
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.
measure: Change from Baseline (T1) Systolic and Diastolic Blood pressure at 13 months
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.
measure: Change from Baseline (T1) Cardiorespiratory Fitness at 13 months
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.
measure: Change from Baseline (T1) Muscle strength at 13 months. Range of Motion of Dynamic strength measurement
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 5:00 PM and 8:00 PM.
measure: Change from Baseline (T1) Muscle strength at 13 months. Dynamic strength measurement
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 5:00 PM and 8:00 PM.
measure: Change from Baseline (T1) Muscle strength at 13 months. Isometric strength measurement
timeFrame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 5:00 PM and 8:00 PM.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: