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Completed

NCT Number: NCT03699683

Physical Activity Program After Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery and Physical Activity Behavior Motor Activity

Age range

35 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cardiovascular diseases
  • Chronic respiratory deseases
  • Cancer in the 5 years prior to surgery
  • Severe functional limitations

Treatment and study plan

Combined aerobic and resistance training program

Other

Primary outcomes

  1. Change from Baseline (T1) Total Cholesterol Blood Samples at 13 months

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.

    Blood samples were taken at the Vinalopó-Salud Hospital of Elche (Spain), after a 12 h fast and 48 h before the test and without performing exercise in that period. Total cholesterol was measured using standard methods.

  2. Change from Baseline (T1) HDL Cholesterol Blood Samples at 13 months

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.

    Blood samples were taken at the Vinalopó-Salud Hospital of Elche (Spain), after a 12 h fast and 48 h before the test and without performing exercise in that period. HDL cholesterol was measured using standard methods.

  3. Change from Baseline (T1) Glucose Blood Samples at 13 months

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.

    Blood samples were taken at the Vinalopó-Salud Hospital of Elche (Spain), after a 12 h fast and 48 h before the test and without performing exercise in that period. Glucose was measured using standard methods.

  4. Change from Baseline (T1) Triglycerides Blood Samples at 13 months

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.

    Blood samples were taken at the Vinalopó-Salud Hospital of Elche (Spain), after a 12 h fast and 48 h before the test and without performing exercise in that period. Triglycerides were measured using standard methods.

  5. Change from Baseline (T1) Body composition at 13 months

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.

    Body mass index (BMI) was calculated according to the formula: total weight in kilograms divided by squared height in meters (kg·m-2). Participants performed the assessment with an empty bladder. Bioimpedance analysis (Tanita, TBF 300A, Tokyo, Japan) was used to establish body weight and body composition.

  6. Change from Baseline (T1) waist and hip circumference at 13 months

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.

    The ISAK (International Society for the Advancement of Kinanthropometry) protocol was used to assess waist and hip circumference.

  7. Change from Baseline (T1) Systolic and Diastolic Blood pressure at 13 months

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.

    A digital sphygmomanometer (Microlife WatchBP Home, Heerbrugg, Switzerland) was used to measure blood pressure, according to established recommendations.

  8. Change from Baseline (T1) Cardiorespiratory Fitness at 13 months

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 8:00 AM and 9:00 AM.

    The maximum oxygen consumption (VO2max) was determined indirectly following the protocol previously published (YMCA) on a cycle ergometer (Technogym Bike Med, Technogym, Gambettola, Italy). The VO2max was calculated using the following formula: VO2max (ml·Kg-1·min-1) = 1.8 *(6.12 * Wpeak) / BW + 3.5 + 3.5 (in which "BW" is body mass in kilograms and "Wpeak" is the power output in watts). Additionally, VO2max was expressed in absolute values (VO2max abs), relative to FFM (VO2max/FFM) and relative to each individual's body weight (VO2max/BW). A digital sphygmomanometer (Tango+, Suntech, USA) was used for the assessment of blood pressure and an electrocardiogram was also administered. An experienced exercise physiologist together with a cardiologist supervised all the cardiorespiratory tests.

  9. Change from Baseline (T1) Muscle strength at 13 months. Range of Motion of Dynamic strength measurement

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 5:00 PM and 8:00 PM.

    Participants performed 1 submaximal trial (1st set) to get used to the range of motion and the accommodating resistance of the dynamometer.

  10. Change from Baseline (T1) Muscle strength at 13 months. Dynamic strength measurement

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 5:00 PM and 8:00 PM.

    Participants performed 3 sets of 4 concentric contractions (flexion-extension) of lower body (knee), at an angular speed of 60º/s, with 90 s rest between repetitions. The knee motion ranges were within 105° to 10°. The participants were verbally encouraged to perform and maintain maximal effort in every contraction. The peak torque (N·m) of each set was analyzed and the average of the last three sets was calculated. Additionally, the peak torque was normalized to the individual's body weight (N·m·kg-1∙100) and relative to FFM (N·m·FFM-1∙100).

  11. Change from Baseline (T1) Muscle strength at 13 months. Isometric strength measurement

    Time frame: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 5:00 PM and 8:00 PM.

    Participants completed four repetitions of a Maximum Voluntary Contraction trial (15 s rest between repetitions), during which they were verbally encouraged to perform a maximal effort for 5 s. The first repetition was a submaximal familiarization trial. The angles used for assessing quadriceps and hamstrings were of 105º and 75º, respectively. As there was one set per exercise, the peak torque (N·m) was analyzed and normalized to each participant´s body weight (N·m·kg-1∙100) and individual FFM (N·m·FFM-1∙100).

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Registry information

Official study title

A Supervised Exercise Program After Bariatric Surgery Avoids Fat-Free Mass Loss And Reduces Cardiovascular Risk Factors

Important dates

Study start
2010
Primary completion
2013
Study completion
2017
First posted
Oct 9, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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