Physical Activity Program Before Bariatric Surgery

NCT03613766 | Completed

• 1 other identifier: 2016.234.E.OEP
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Weight reduction, especially of visceral fat in patients awaiting bariatric surgery (BS), may facilitate the surgical process, and reduce postoperative complications. Normally, to achieve weight reductions a nutritional treatment is prescribed, but the effects of exercise on these patients have been little studied. Objectives: To know the effects of an exercise program on body composition and cardiovascular risk factors in patients awaiting BS. Methods: Twenty-three patients awaiting BS were divided into two groups: a) an experimental group (EG, n = 12); b) a control group (CG, n = 11). Both groups received the usual care prior to surgery, but the EG also performed a 12-week exercise program in which endurance and resistance training were combined. Body composition, anthropometric measures, cardiovascular risk factors, physical fitness, basal metabolic rate and quality of life were assessed at baseline and at the end of the study.

Conditions

Bariatric Surgery Candidate; Physical Activity

Outcome Measures

Primary Outcomes (6)

• Change from Baseline Body Composition at 3 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 BC-420MA, Tanita, Tokyo, Japan) was used to establish body weight and body composition.

  Baseline and 3 months, between 7:30 AM and 8:30 AM.

• Change from Baseline Cardiorespiratory Fitness at 3 months

  A protocol in cycle ergometer (Technogym Bike Med, Technogym, Gambettola, Italy) adapted Achten was used to determine the peak oxygen uptake (VO2peak) using an Oxycon Pro gas analysis system (Jaeger, Friedberg, Germany). This protocol consisted of two phases. In the first phase, patients performed a 4-minutes warm-up at 40 watts (W), followed by increases of 20 W every 3 minutes, maintaining a cadence of 60 rotations per minute (RPM), until the respiratory exchange ratio (RER) reached 1.0. At this point the second phase started, which consisted of increments of 20 w each minute, maintaining a cadence between 70-80 RPM, until volitional fatigue. The average of the highest 30 seconds of VO2 was used to calculate VO2peak. The VO2peak was expressed in absolute values (VO2peak abs) and normalized to total body weight (VO2peak/BW) and fat- free mass (VO2peak/FFM)

  Baseline and 3 months, between 8:00 AM and 9:00 AM.

• Change from Baseline Muscle strength at 3 months. Dynamic strength measurement

  Dynamic and isometric strength of the quadriceps, hamstrings, biceps and triceps brachii were assessed using an isokinetic dynamometer (Biodex System 4; Biodex Medical Systems, New York, USA). Participants performed 4 sets of 4 concentric contractions (flexion-extension) of the upper (elbow) and lower body (knee), at an angular speed of 60º/s, with 90 s rest between repetitions. The knee and elbow motion ranges were within 105° to 10° and within 160° to 60°, respectively. The first series was a submaximal familiarization trial. In the following three sets, 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 (MDSBW) and relative to FFM (MDSFFM)

  Baseline and 3 months, between 8:00 AM and 9:00 AM.

• Change from Baseline Muscle strength at 3 months. Isometric strength measurement

  Dynamic and isometric strength of the quadriceps, hamstrings, biceps and triceps brachii were assessed using an isokinetic dynamometer (Biodex System 4; Biodex Medical Systems, New York, USA). Participants completed a submaximal repetition followed by 3 maximum voluntary contraction (15 s rest between repetitions), during which they were verbally encouraged to perform a maximal effort for 5 s, following the recommendations of previous research. The angles used for assessing quadriceps and hamstrings were of 105º and 75º, respectively, and triceps and biceps brachii were of 75º and 120º, respectively. As there was one set per exercise, the peak torque (N·m) was analyzed and normalized to the body weight (MISBW) and individual's FFM (MISFFM).

  Baseline and 3 months, between 8:00 AM and 9:00 AM.

• Change from Baseline Cardiovascular risk factors at 3 months.

  Blood samples were taken at the University Hospitals, after 12 hours overnight fast. Patients were instructed not to perform exercise 48 hours before the test. Standard methods were used to measure total cholesterol (TC), HDL cholesterol (HDL-C), glucose, HbA1C, and triglycerides (TG). Friedwald equation was used for calculating LDL cholesterol (LDL-C). Blood pressure was measured according to established recommendations, using a digital sphygmomanometer (Microlife WatchBP Home, Heerbrugg, Switzerland). Framingham cardiac risk score adapted to the Spanish context was used to calculate CVR. This formula, uses the TC, HDL-C, blood pressure values, sex, age, diabetic and/or smoking status, to calculate the 10-year coronary risk. In some subjects of the CG, this formula could not be applied, since they were less than 35 years old, thus, CVR was also determined by the waist-to-hip ratio (WHpR) (45) and by the waist-to-height ratio (WHtR)

  Baseline and 3 months, in a different day of the other tests, between 8:00 AM and 9:00 AM.

• Change from Baseline waist and hip circumference at 3 months

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

  Baseline and 3 months, between 7:30 AM and 8:30 AM.

Secondary Outcomes (2)

• Change from Baseline Basal metabolic rate at 3 months

  Baseline and 3 months, in a different day of the other tests, between 8:00 AM and 9:00 AM.

• Change from Baseline Health-related quality of life at 3 months

  Baseline and 3 months, between 8:00 AM and 9:00 AM.

Study Arms (2)

Physical activity program

EXPERIMENTAL

Before 3 to 6 months before the expected date of surgery, the experimental group, performed a 12-week monitored and supervised concurrent exercise program. Before and after of this period, body composition, anthropometric measures, physical fitness, cardiovascular risk, blood samples, Basal Metabolic Rate and health-related quality of life were measured in a laboratory under controlled conditions.

Other: Physical activity program

Habitual care prescription

NO INTERVENTION

Before 3 to 6 months before the expected date of surgery, the control group, followed the habitual care prescriptions until the surgery

Interventions

Physical activity program OTHER

Physical activity program

Eligibility Criteria

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

You may qualify if:

• Be on the surgery waiting list.
• Follow the doctor's usual health prescriptions

You may not qualify if:

• cardiovascular diseases
• severe functional limitations
• chronic respiratory diseases
• being undergoing another exercise program at the time of the study

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Related Publications (1)

• Marc-Hernandez A, Ruiz-Tovar J, Aracil A, Guillen S, Moya-Ramon M. Impact of Exercise on Body Composition and Cardiometabolic Risk Factors in Patients Awaiting Bariatric Surgery. Obes Surg. 2019 Dec;29(12):3891-3900. doi: 10.1007/s11695-019-04088-9.

  PMID: 31313237 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• 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). Chronological order of recruitment

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 3, 2018
• Study Start: September 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: June 30, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-07