Bariatric Surgery CandidateNCT03159312
Influence of a Moderate Physical Exercise Program in Health of Patients Underwent Bariatric Surgery in Talca City, Chile
A study testing Physical activity based on a moderate exercise program in people with Bariatric Surgery Candidate, run by Universidad de Granada at 1 site in Spain.
Trial summary
Obesity is a multifactorial disorder resulting from multivariate etiopathogenic factors. The current lifestyle, causes a gradual increase in weight both in the adult population and in the child population. Among their treatments is bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Physical activity based on a moderate exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2017to 18 Mar 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent.
- Do not suffer any absolute contraindication.
- Patients who will undergo bariatric surgery and who reside in the city of Talca.
- Age between 18 - 60 years.
- With weight <180 kilograms.
Who cannot join
- Medical indication for basic pathologies.
- Post-operative complications.
- Acute angina-like pain during the 6-minute gait test.
- Absence of 2 or more trainings in a row.
- Pregnancy within the first 6 months post-surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is a multifactorial disorder resulting from multivariate etiopathogenic factors. The current lifestyle, causes a gradual increase in weight both in the adult population and in the child population. Among their treatments is bariatric surgery. About which there is little evidence in the literature regarding the health condition developed by patients operated on the same. Objective: To know the influence of a moderate exercise program on health status in patients operated on with bariatric surgery. Methodology: A controlled clinical trial, the population will consist of 32 women and 11 men. Coming from the consultations of bariatric surgery of the Clinic of the Maule - Talca. In the period between March 2017 and March 2018. It will be selected following a non-probabilistic sampling and for convenience. Results Analysis: The variables used in this study will be: cardiovascular function, respiratory function, strength, health perception, anthropometric measures and functional capacity to perform exercises. The Shapiro-Wilk normality test will be performed to determine the distribution of the data to be analyzed. The t-student test or its nonparametric counterpart will be applied to compare two variables. To compare three or more variables, the ANOVA or Kruskal-Wallis test will be used depending on the results of the normality test.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Physical activity based on a moderate exercise program
- Keywords
- obesity,bariatric surgery,physical activity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity based on a moderate exercise programBehavioural
Physical exercise program begins with a 2-week adaptation stage, climbs onto the treadmill (HP Cosmos®). The programming of the tape will be done initially with an intensity of 40% of its FCdRes obtained from the formula of Karvonen after performing the 6-minute walk test, you will have to maintain that intensity for 15 min, the patient is evaluated with the Borg scale and oxygen saturation permanently.After two weeks of adaptation, the HRdRes becomes to be calculated, 59% of said frequency will be modified until the exercise program is completed.The training is 30 minutes in the tradmill machine.The work of muscle strengthening of biceps, triceps, deltoids and pectorals, will be progressive in intensity and number of repetitions, determined by the evaluation of 1 Rmax. The start of work with weights is 40% of the Rmax, it will be modified monthly from 40% to 75%. Cycloergometer training (Monark ®) is without load for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | 20 individuals undergoing bariatric surgery and post surgery normal indications with moderate exercise program Receives: Behavioral: Physical activity based on a moderate exercise program |
| Control group | No intervention | Control group: 23 individuals undergoing bariatric surgery and post surgery normal indications without exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life prior to bariatric surgery and subsequent
Nottingham Scale: It is a generic instrument for measuring the physical, psychological and social suffering associated with medical, social and emotional problems of the extent to which such suffering affects the lives of individuals, and ICIQ-SF urinary incontinence questionnaire
Measured: 1 year
Secondary outcomes (10)
Blood sugar level
Hemoglucotest, for measuring peripheral blood glucose
Measured: 1 year
Quality of sleep
Pittsburgh Sleep Quality Questionnaire
Measured: 1 year
Anthropometric measures
Rosscraft anthropometry kit containing Campbell 20 (Campbell 10) and Bioelectrical impedance.
Measured: 1 year
Level of physical ability
Borg scale
Measured: 1 year
Level of physical ability
6-minute walk test
Measured: 1 year
Perception of health
Assessment pre-operated patients bariatric surgery
Measured: 1 year
Cardiovascular function
With dynamometer
Measured: 1 year
Cardiovascular function
Tensiometers cable
Measured: 1 year
Cardiovascular function
Cells of load.
Measured: 1 year
Strength
To analyze the strength and the dynamic resistance were used: free weights (dumbells and bars) exercise machines with constant, variable or isokinetic resistance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start30 Mar 2017
- Primary completion15 Mar 2018
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María José Aguilar Cordero, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159312
- Sponsor's protocol ID
- 23/01/2017 UGR
- Status last verified
- Oct 2019
- First submitted
- 3 Apr 2017
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Moderate Physical Exercise Program in Health of Patients Underwent Bariatric Surgery in Talca City, Chile
- ClinicalTrials.gov ID
- NCT03159312
- Acronym / sponsor ID
- 23/01/2017 UGR
- Conditions
- Bariatric Surgery Candidate
- Keywords
- obesity,bariatric surgery,physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 18 May 2017 (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.
Obesity is a multifactorial disorder resulting from multivariate etiopathogenic factors. The current lifestyle, causes a gradual increase in weight both in the adult population and in the child population. Among their treatments is bariatric surgery. About which there is little evidence in the literature regarding the health condition developed by patients operated on the same. Objective: To know the influence of a moderate exercise program on health status in patients operated on with bariatric surgery. Methodology: A controlled clinical trial, the population will consist of 32 women and 11 men. Coming from the consultations of bariatric surgery of the Clinic of the Maule - Talca. In the period between March 2017 and March 2018. It will be selected following a non-probabilistic sampling and for convenience. Results Analysis: The variables used in this study will be: cardiovascular function, respiratory function, strength, health perception, anthropometric measures and functional capacity to perform exercises. The Shapiro-Wilk normality test will be performed to determine the distribution of the data to be analyzed. The t-student test or its nonparametric counterpart will be applied to compare two variables. To compare three or more variables, the ANOVA or Kruskal-Wallis test will be used depending on the results of the normality test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Behavioral: Physical activity based on a moderate exercise program20 individuals undergoing bariatric surgery and post surgery normal indications with moderate exercise program |
| Control group | No intervention | –Control group: 23 individuals undergoing bariatric surgery and post surgery normal indications without exercise program |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent.
- Do not suffer any absolute contraindication.
- Patients who will undergo bariatric surgery and who reside in the city of Talca.
- Age between 18 - 60 years.
- With weight <180 kilograms.
Key exclusion criteria (5 listed)
- Medical indication for basic pathologies.
- Post-operative complications.
- Acute angina-like pain during the 6-minute gait test.
- Absence of 2 or more trainings in a row.
- Pregnancy within the first 6 months post-surgery.
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 |
|---|---|---|
| Physical activity based on a moderate exercise programPhysical exercise program begins with a 2-week adaptation stage, climbs onto the treadmill (HP Cosmos®). The programming of the tape will be done initially with an intensity of 40% of its FCdRes obtained from the formula of Karvonen after performing the 6-minute walk test, you will have to maintain that intensity for 15 min, the patient is evaluated with the Borg scale and oxygen saturation permanently.After two weeks of adaptation, the HRdRes becomes to be calculated, 59% of said frequency will be modified until the exercise program is completed.The training is 30 minutes in the tradmill machine.The work of muscle strengthening of biceps, triceps, deltoids and pectorals, will be progressive in intensity and number of repetitions, determined by the evaluation of 1 Rmax. The start of work with weights is 40% of the Rmax, it will be modified monthly from 40% to 75%. Cycloergometer training (Monark ®) is without load for 15 minutes. | Behavioural | Assigned Interventions |
Primary outcome
Quality of life prior to bariatric surgery and subsequent
Time frame: 1 year
Nottingham Scale: It is a generic instrument for measuring the physical, psychological and social suffering associated with medical, social and emotional problems of the extent to which such suffering affects the lives of individuals, and ICIQ-SF urinary incontinence questionnaire
10 secondary outcomes
Blood sugar level
Time frame: 1 year
Quality of sleep
Time frame: 1 year
Anthropometric measures
Time frame: 1 year
Level of physical ability
Time frame: 1 year
Level of physical ability
Time frame: 1 year
Perception of health
Time frame: 1 year
Cardiovascular function
Time frame: 1 year
Cardiovascular function
Time frame: 1 year
Cardiovascular function
Time frame: 1 year
Strength
Time frame: 1 year
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 28 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity based on a moderate exercise program in people with Bariatric Surgery Candidate, run by Universidad de Granada 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 5 inclusion and 5 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 28 Oct 2019. 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?
Quality of life prior to bariatric surgery and subsequent (time frame: 1 year). 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 28 Oct 2019.