A High-Intensity Exercise Program in Post-Bariatric Patients

NCT03603392 | Completed

• 1 other identifier: DPS.MMR.01.15
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Weight regain is one of the most common problems in bariatric patients. Although exercise contributes to maintaining weight, there are currently few studies performed on this population. Objective: To know the effects of a high-intensity exercise program applied 3 years after bariatric surgery on body composition and cardiovascular risk factors. Methods: A 37-month follow-up was performed on 21 patients who underwent bariatric surgery, in which periodic body composition was evaluated. At month 37, participants were divided into an experimental group (EG) and a control group (CG). The EG performed a 5-months of a supervised exercise program. At this point physical fitness, glycemia and cholesterolemia were also evaluated in the EG. Finally, the EG repeated the evaluations 2-months after the end of the program.

Conditions

Bariatric Surgery and Physical Activity

Outcome Measures

Primary Outcomes (7)

• Change from Baseline Body Composition at 5 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 and 5 months, between 8:00 AM and 9:00 AM.

• Change from Baseline waist and hip circumference at 5 months

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

  Baseline and 5 months, between 8:00 AM and 9:00 AM.

• Change from Baseline Systolic and Diastolic Blood pressure at 5 months

  Blood pressure was measured using a digital sphygmomanometer (Microlife WatchBP Home, Heerbrugg, Switzerland), according to established recommendations

  Baseline and 5 months, between 8:00 AM and 9:00 AM.

• Change from Baseline Capillary Blood Samples at 5 months

  Capillary blood samples were taken to analyse blood glucose and TC using a portable multi-analyser (Accutrend GCT, Roche Diagnostics, Mannheim, Germany)

  Baseline and 5 months, between 8:00 AM and 9:00 AM.. Measurements only performed at the experimental group

• Change from Baseline Cardiorespiratory Fitness at 5 months

  he peak oxygen uptake (VO2peak) was determined on a cycle ergometer (Technogym Bike Med, Technogym, Gambettola, Italy), using an Oxycon Pro gas analysis system (Jaeger, Friedberg, Germany) by adapted protocol from Achten. The protocol had two phases: a) a first phase in which the participants performed a 4-minute warm-up at 40 watts (W), followed by increases of 20 W every 3 minutes, maintaining a cadence of 60 rotations per minute (RPM) during the whole phase; and, b) a second phase that started when the respiratory exchange ratio reached 1.0, and which was aimed to determine the VO2peak. This phase consisted of increments of 20 W every minute, maintaining a cadence between 70-80 RPM, until volitional fatigue. The VO2peak was calculated as the average of the highest 30 seconds of VO2. 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 5 months, between 8:00 AM and 9:00 AM. Measurements only performed at the experimental group

• Change from Baseline Cardiovascular Risk at 5 months

  The SCORE risk charts of the European Society of Cardiology were used to calculate CVR. The formula to calculate CVR estimates the 10-year coronary risk using Total Cholesterol, systolic blood pressure, gender, age, and smoking status. The underlying survival probability, S0, is given by: S(age)={S0(age)}exp(w) S(age)={S0(age)}exp(w) S(age+10)={S0(age+10)}exp(w)S(age+10)={S0(age+10)}exp(w) Where w=βchol(cholesterol-6)+βSBP(SBP-120)+βsmoker(current)w=βchol(cholesterol-6)+βSBP(SBP-120)+βsmoker(current) For each cause, calculate the 10-year survival probability based on the survival probability for the person's current age and their age in 10 years time: S10(age)=S(age+10)/S(age)S10(age)=S(age+10)/S(age) Calculate the 10-year risk for each end-point as Risk10=1-S10(age)Risk10=1-S10(age) The scale range ordered by the 10-year risk of fatal cardiovascular desease are: 15% and over, between 10%-14%, between 5%-9%, Between 3%-4%, 2%, 1%, under 1%.

  Baseline and 5 months, between 8:00 AM and 9:00 AM.

• Change from Baseline Health Status at 5 months

  The health-related quality of life was measured by the Short Form Health Survey 36 (SF-36), in its version adapted to the Spanish context. This questionnaire measures physical and mental health through 8 scales, the scores of which are transformed to values between 0-100 points, with the highest scores meaning a better function. These 8 scales are grouped into two summary components, the physical summary component, and the mental summary component, which were calculated according to the reference values of the Spanish population, with a mean of 50 and a standard deviation of 10.

  Baseline and 5 months, between 8:00 AM and 9:00 AM. Measurements only performed at the experimental group

Study Arms (1)

Physical activity program

EXPERIMENTAL

Before and after a 5-months of a supervised exercise program were performed in post bariatric patients, body composition, physical fitness and cardiovascular risk factors were measured.

Other: Physical activity program

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:

• Absence of cardiovascular disease
• They had not suffered any type of cancer in the 5-year period before surgery
• Absence of functional limitations that prevented them from performing the exercise program

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Manuel

Elche, Alicante, 03202, Spain

Location

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: July 4, 2018
• First Posted: July 27, 2018
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2016
• Last Updated: July 27, 2018

Record last verified: 2018-07

Locations

ES (1)