Bariatric Surgery and Physical ActivityNCT03699683
Physical Activity Program After Bariatric Surgery
A study testing Combined aerobic and resistance training program in people with Bariatric Surgery and Physical Activity, run by Universidad Miguel Hernandez de Elche.
Trial 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. 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?
- Combined aerobic and resistance training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2010to 1 Sep 2017
- 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
- Meet the age requirements
- Be a patient of the reference hospital.
- Follow the doctor's usual health prescriptions
Who cannot join
- Cardiovascular diseases
- Chronic respiratory deseases
- Cancer in the 5 years prior to surgery
- Severe functional limitations
About this study
Official title: A Supervised Exercise Program After Bariatric Surgery Avoids Fat-Free Mass Loss And Reduces Cardiovascular Risk Factors
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.
Read the detailed description
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
- Conditions
- Bariatric Surgery and Physical Activity
- Being tested
- Combined aerobic and resistance training 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.
Combined aerobic and resistance training programOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Combined aerobic and resistance training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline (T1), at 7 months (T2) and at 13 months (T3), between 5:00 PM and 8:00 PM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Sep 2010
- Primary completion1 Sep 2013
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery and Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Moya, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699683
- Sponsor's protocol ID
- 2015.60.E.OEP
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Supervised Exercise Program After Bariatric Surgery Avoids Fat-Free Mass Loss And Reduces Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT03699683
- Acronym / sponsor ID
- 2015.60.E.OEP
- Conditions
- Bariatric Surgery and Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Sep 2013 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- two groups (experimental and control) randomly assigned
| Arm | Type | Receives |
|---|---|---|
| Physical Combined Activity Program | Experimental | Other: Combined aerobic and resistance training programBefore 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) |
Who may qualify
- Ages
- 35 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meet the age requirements
- Be a patient of the reference hospital.
- Follow the doctor's usual health prescriptions
Key exclusion criteria (4 listed)
- Cardiovascular diseases
- Chronic respiratory deseases
- Cancer in the 5 years prior to surgery
- Severe functional limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined aerobic and resistance training program | Other | Physical Combined Activity Program |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Combined aerobic and resistance training program in people with Bariatric Surgery and Physical Activity, run by Universidad Miguel Hernandez de Elche.
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 4 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 (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.). The study lists 11 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 9 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.