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Bariatric Surgery and Physical ActivityNCT03603392

A High-Intensity Exercise Program in Post-Bariatric Patients

A study testing Physical activity program in people with Bariatric Surgery and Physical Activity, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 57 years
Conditions the study is for
Bariatric Surgery and Physical Activity
What is being tested?
Physical activity program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSpain
Study dates
1 Sep 2010to 1 Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 57 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Manuel

    Elche, Alicante, 03202

Other trials in Spain

About this study

Official title: A High-Intensity Exercise Program Stops Weight Regain and Improves Cardiovascular Profile in Post-Bariatric Patients

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.

Read the detailed description

A total of 40 patients from the Vinalopó-Salud Hospital of Elche (Spain) who underwent bariatric surgery between 2010-2013, were recruited. Male and female participants were eligible if they complied with the following inclusion criteria: a) absence of cardiovascular disease; b) they had not suffered any type of cancer in the 5-year period before surgery; c) absence of functional limitations that prevented them from performing the exercise program.

Before starting the study, an initial interview was conducted with the patients to verify that they complied with the inclusion criteria. In this interview, all aspects of the program were carefully explained. At the start of the study, all patients who had agreed to participate signed an informed consent. This study was conformed to the Declaration of Helsinki and approved by the Ethics Committees of the University. Two patients declined to participate in the study after the initial interview. Finally, 38 patients started the study and 18 finished it.

One month after surgery, participant's body composition, anthropometric measures and resting blood pressure were assessed. These assessments were performed periodically every six months until month 19 after surgery. At an average of 37.10 ± 4.35 months of follow-up after surgery, they were distributed into two groups, an experimental group (EG; n=10), and a control group (CG; n=8). The EG group performed a monitored exercise program, while only the evaluations were performed in the CG. At this point, measurements of cardiorespiratory fitness and biochemical parameters were added to the previous assessments (anthropometric measures and blood pressure) for the EG. An assessment was performed coinciding with the start of the exercise program (which lasted 20 weeks), and a final assessment was also performed at the end of the program. Finally, the EG was evaluated 2 months after the end of the exercise program.

Body composition, waist and hip circumference, blood pressure and biochemical parameters were evaluated between 8:00 ante meridien (AM) and 9:00 AM. Cardiorespiratory fitness was evaluated between 4:00 post meridien (PM) and 8:00 PM. Measurements were performed in a climatically controlled laboratory, located at 80 m above sea level, in which the relative air humidity was maintained between 45-60% and the temperature between 22-24º.

Body composition, anthropometric measures and cardiovascular risk factors (CVRF) After at least 10 hours of fasting, body composition, biochemical parameters and blood pressure were measured. Alcohol consumption was restricted for at least 8 hours before the test, while PA was forbidden in the 48 hours prior to the test. Participants performed the assessment with an empty bladder. Bioimpedance analysis (Tanita, TBF 300A, Tokyo, Japan) was used to establish body weight and body composition. Body mass index (BMI) was calculated according to the formula: total weight in kilograms divided by squared height in meters (kg·m-2). The International Society for the Advancement of Kinanthropometry (ISAK) protocol was used to assess height and waist and hip circumference. Blood pressure was measured using a digital sphygmomanometer (Microlife WatchBP Home, Heerbrugg, Switzerland), according to established recommendations. Capillary blood samples were taken to analyse blood glucose and Total Cholesterol (TC) using a portable multi-analyser (Accutrend GCT, Roche Diagnostics, Mannheim, Germany).

Cardiorespiratory fitness The 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).

Cardiovascular risk (CVR) 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 TC, systolic blood pressure, gender, age, and smoking status. In addition, CVR was also calculated using waist to hip ratio, and waist to height ratio.

Health-related quality of life 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.

The exercise program lasted 20 weeks, which were distributed in five 4-week blocks. The first -block included two weekly sessions, in which the endurance training (ET) and the resistance training (RT) for 5 muscle groups (hamstrings, pectorals, quadriceps, latissimus dorsi, and gastrocnemius) was combined in the same session. In the second block participants trained 3 days a week, in two of them a high-intensity interval training (HIIT) was performed, followed by RT (biceps and triceps were added to the previous 5 major muscle groups trained), while in the third session only the ET was performed. Between the third and fifth block participants trained 4 days a week. In two sessions, a HIIT was performed, followed by RT, focusing on different muscle groups in each session: a) session 1: pectorals, quadriceps, biceps, and hamstrings; b) session 2: dorsal, triceps, gastrocnemius and deltoids. In the other two sessions, ET was performed. In all the blocks, 2 days a week of flexibility training were carried out.

The ET (performed on a cycle-ergometer, elliptical and treadmill) was monitored using a heart rate (HR) monitor (FT40, Polar, Finland). The RT was performed using resistance machines, and training intensity was determined by percentages of 1 maximum repetition which was estimated using the Brzycki formula.

The HIIT consisted of a five-minute warm up, increasing the intensity from 40% of VO2peak to 60% VO2peak. After this, 20 minutes with bouts of 30 seconds at high intensity (60-95% VO2peak) and 30 seconds of active recovery (40% VO2peak), for a total of 10 minutes of training at high intensity were performed. Finally, 3 minutes of cool-down at 40% VO2peak were performed.

Being tested
Physical activity program
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity programOther

Study groups in NCT03603392
Study groupRoleWhat they receive
Physical activity programExperimentalBefore 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.
Receives: Other: Physical activity program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

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

  3. 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

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

  4. 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)

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

  5. 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).

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

  6. 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%.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start1 Sep 2010
  3. Primary completion1 Sep 2013
  4. Study completion1 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Intervention model
Sequential
Model description
two groups (experimental and control) randomly assigned
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603392
Sponsor's protocol ID
DPS.MMR.01.15
Status last verified
Jul 2018
First submitted
4 Jul 2018
Last updated
27 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity program in people with Bariatric Surgery and Physical Activity, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Body Composition at 5 months (time frame: Baseline and 5 months, between 8:00 AM and 9:00 AM.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.

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