Morbid ObesityNCT03975244
Semi-supervised Exercise Program Before Bariatric Surgery
A study testing Exercise program in people with Morbid Obesity and Exercise, run by Hospital General Universitario Elche.
Trial summary
Background: Patients awaiting bariatric surgery, apart from suffering higher BMI, show a large number of comorbidities and a low physical fitness. These factors are associated with a longer surgery time, a longer hospital stay and a greater number of operative complications. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Morbid Obesity, Exercise, Bariatric Surgery
- What is being tested?
- Exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 30 Nov 2020
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-55 years.
- All patients awaiting bariatric surgery.
Who cannot join
- Patients with chronic respiratory diseases
- Patients with cardiovascular diseases
- Inability to perform exercise
About this study
Official title: Effects of Exercise on Body Composition, Cardiovascular Risk Factors and Surgery Complications in Bariatric Patients
Background: Patients awaiting bariatric surgery, apart from suffering higher BMI, show a large number of comorbidities and a low physical fitness. These factors are associated with a longer surgery time, a longer hospital stay and a greater number of operative complications. To reduce these disadvantages, a nutritional intervention is performed to reduce total weight and the comorbidities associated with obesity prior to surgery. However, the prescription of an exercise program, which can be an effective tool to improve these factors, is not usually part of the usual care of these patients.
Objective: To know the effects of a semi-supervised exercise program on body composition, cardiovascular risk factors and operative complications in bariatric patients.
Methods: Approximately 3 months before surgery, 60 patients awaiting bariatric surgery will be recruited. Patients will be randomized into two groups: a) an experimental group (n = 30); b) a control group (n = 30). The experimental group will perform a semi-supervised exercise program, while the control group will only perform the corresponding evaluations. Both groups will be assessed for body composition, cardiovascular risk factors, physical condition, quality of life and physical activity levels at the beginning and at the end of the intervention. In addition, surgery time, hospital length of stay and operative complications will be evaluated in both groups.
- Conditions
- Morbid Obesity, Exercise, Bariatric Surgery
- Being tested
- Exercise program
- Medical subject headings
- Obesity, Morbid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programBehavioural
Also called Exercise program in patients awaiting bariatric surgery.
Twelve-week of semi-supervised exercise program. The exercise program will combine resistance and endurance training. Both the volume and intensity of training will start at moderate intensity, and progressively be increased at higher volumes and intensities.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Three months of semi-supervised exercise program in patients awaiting bariatric surgery. Body composition, cardiovascular risk factors, physical fitness, physical activity levels and quality of life will be assessed before and at the end of the study. In addition, surgery time, hospital length of stay and operative complications also will be evaluated. Receives: Behavioral: Exercise program |
| Control group | No intervention | The control group only will perform the evaluations of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition - Body mass index
Bioimpedance analysis will be used for establishing body weight and body composition. This variables will be evaluated between 8:00 and 9:00 A.M., after at least 8 hours of fasting, with an empty bladder. Body mass index will be calculated dividing weight in kilograms by squared height in meters. Therefore, body mass index will be expressed as kg·m-2.
Measured: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Change in glucose and HbA1c levels.
Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.
Measured: Baseline and 3 months, between 8:00 AM and 10:00 AM.
Change in total cholesterol, HDL cholesterol and LDL cholesterol levels.
Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.
Measured: Baseline and 3 months, between 8:00 AM and 10:00 AM.
Change in systolic and diastolic blood pressure.
Systolic and Diastolic Blood pressure will be measured according to established recommendations.
Measured: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Complications rates
All the complications suffered by patients will be recorded.
Measured: Day 30 after surgery.
Length of stay.
The number of days at hospital after bariatric surgery will be recorded.
Measured: Day 15 after surgery.
Change in handgrip strength
Strength levels will be assessed using a hand dynamometer.
Measured: Baseline and 3 months, between 5:00 PM and 8:00 PM.
Secondary outcomes (3)
Change in physical activity levels.
Levels of physical activity will be measured recording the physical activity performed for 7 days using an accelerometer.
Measured: Baseline and 3 months, seven days.
Change in health-related quality of life: sf-36 questionnaire.
The Spanish version of Short Form Health Survey 36 (SF-36) will be used for knowing changes in quality of life. This questionnaire uses 8 scales to evaluate physical health (4 scales: Physical Function, Role Physical, Bodily Pain, General Health) and mental health (4 scales: Vitality, Social functioning, Role Emotional, and Mental Health). The scores of these scales are transformed into values between 0-100 points, where highest scores are related to better function. These 8 scales are grouped into two summary components (physical summary component; mental summary component) which will be calculated according to the reference values of the Spanish population, with a mean of 50 and standard deviation of 10.population.
Measured: Baseline and 3 months.
Change in waist and hip circumference.
Waist and hip circumference will be measured in centimeters, using established recommendations.
Measured: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975244
- Sponsor's protocol ID
- HRJC-19_Ex.Bar
- Status last verified
- May 2019
- First submitted
- 30 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Body Composition, Cardiovascular Risk Factors and Surgery Complications in Bariatric Patients
- ClinicalTrials.gov ID
- NCT03975244
- Acronym / sponsor ID
- HRJC-19_Ex.Bar
- Conditions
- Morbid Obesity, Exercise, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 5 Jun 2019 (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: Patients awaiting bariatric surgery, apart from suffering higher BMI, show a large number of comorbidities and a low physical fitness. These factors are associated with a longer surgery time, a longer hospital stay and a greater number of operative complications. To reduce these disadvantages, a nutritional intervention is performed to reduce total weight and the comorbidities associated with obesity prior to surgery. However, the prescription of an exercise program, which can be an effective tool to improve these factors, is not usually part of the usual care of these patients.
Objective: To know the effects of a semi-supervised exercise program on body composition, cardiovascular risk factors and operative complications in bariatric patients.
Methods: Approximately 3 months before surgery, 60 patients awaiting bariatric surgery will be recruited. Patients will be randomized into two groups: a) an experimental group (n = 30); b) a control group (n = 30). The experimental group will perform a semi-supervised exercise program, while the control group will only perform the corresponding evaluations. Both groups will be assessed for body composition, cardiovascular risk factors, physical condition, quality of life and physical activity levels at the beginning and at the end of the intervention. In addition, surgery time, hospital length of stay and operative complications will be evaluated in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise programThree months of semi-supervised exercise program in patients awaiting bariatric surgery. Body composition, cardiovascular risk factors, physical fitness, physical activity levels and quality of life will be assessed before and at the end of the study. In addition, surgery time, hospital length of stay and operative complications also will be evaluated. |
| Control group | No intervention | –The control group only will perform the evaluations of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 20-55 years.
- All patients awaiting bariatric surgery.
Key exclusion criteria (3 listed)
- Patients with chronic respiratory diseases
- Patients with cardiovascular diseases
- Inability to perform exercise
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 |
|---|---|---|
| Exercise programAlso: Exercise program in patients awaiting bariatric surgery.Twelve-week of semi-supervised exercise program. The exercise program will combine resistance and endurance training. Both the volume and intensity of training will start at moderate intensity, and progressively be increased at higher volumes and intensities. | Behavioural | Exercise group |
Primary outcome
Change in body composition - Body mass index
Time frame: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Bioimpedance analysis will be used for establishing body weight and body composition. This variables will be evaluated between 8:00 and 9:00 A.M., after at least 8 hours of fasting, with an empty bladder. Body mass index will be calculated dividing weight in kilograms by squared height in meters. Therefore, body mass index will be expressed as kg·m-2.
Change in glucose and HbA1c levels.
Time frame: Baseline and 3 months, between 8:00 AM and 10:00 AM.
Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.
Change in total cholesterol, HDL cholesterol and LDL cholesterol levels.
Time frame: Baseline and 3 months, between 8:00 AM and 10:00 AM.
Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.
Change in systolic and diastolic blood pressure.
Time frame: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Systolic and Diastolic Blood pressure will be measured according to established recommendations.
Complications rates
Time frame: Day 30 after surgery.
All the complications suffered by patients will be recorded.
Length of stay.
Time frame: Day 15 after surgery.
The number of days at hospital after bariatric surgery will be recorded.
Change in handgrip strength
Time frame: Baseline and 3 months, between 5:00 PM and 8:00 PM.
Strength levels will be assessed using a hand dynamometer.
3 secondary outcomes
Change in physical activity levels.
Time frame: Baseline and 3 months, seven days.
Change in health-related quality of life: sf-36 questionnaire.
Time frame: Baseline and 3 months.
Change in waist and hip circumference.
Time frame: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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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 Exercise program in people with Morbid Obesity and Exercise, run by Hospital General Universitario 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jun 2019. 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?
Results are not available in the source record.
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 in body composition - Body mass index (time frame: Baseline and 3 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 5 Jun 2019.