Physical Activity Program After Bariatric Surgery

NCT03699683 | Completed

• 1 other identifier: 2015.60.E.OEP
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bariatric Surgery and Physical Activity

Outcome Measures

Primary Outcomes (11)

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

• Change from Baseline (T1) Body composition at 13 months

  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.

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

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

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

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

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

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

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

• Change from Baseline (T1) Cardiorespiratory Fitness at 13 months

  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.

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

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

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

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

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

  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).

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

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

  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).

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

Study Arms (1)

Physical Combined Activity Program

EXPERIMENTAL

Before and after a 6-months supervised and individualized program that combined aerobic and resistance training were performed in post bariatric patients. Body composition, physical fitness and cardiovascular risk factors were measured before, after the physical activity program and 6 months later (13 months sinde the program started)

Other: Combined aerobic and resistance training program

Interventions

Combined aerobic and resistance training program OTHER

Physical Combined Activity Program

Eligibility Criteria

• Age: 35 Years - 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two groups (experimental and control) randomly assigned

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2017
• Last Updated: October 9, 2018

Record last verified: 2018-10