Morbid ObesityNCT02406976
Effect Physical Exercise in Morbid Obesity
A study testing G1 -Exercise and G2- Exercise and Lifestyle in people with Morbid Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This objective study to verify the effect of physical training with and without behavioral cognitive therapy, compared with controls, in functional capacity and cardio-metabolic profile in individuals with morbidly obese Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- G1 -Exercise and G2- Exercise and Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with morbid obesity
- Individuals do not have contraindications to practice low-intensity exercise.
Who cannot join
- Contraindications to physical exercise
- Cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association)
- Orthopedic problems
- Severe retinopathy
- Severe neuropathy
- Drug addicts and severe mental illness
- High blood pressure or metabolic decompensation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035 903
About this study
Official title: Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity
This objective study to verify the effect of physical training with and without behavioral cognitive therapy, compared with controls, in functional capacity and cardio-metabolic profile in individuals with morbidly obese
Read the detailed description
This study is a Randomized Clinical Trial, with individuals with morbid obesity, and will be consists of 3 groups:
- Group 1 (G1 EXERCISE): This group will participate in an physical exercise program twice a week in hospital.
- Group 2 (G2 - LIFESTYLE AND EXERCISE): This groups will receive the same G1 intervention associated with a weekly group followed up with techniques of cognitive behavioral therapy with a psychologist
- Group 3 (G3 - CONTROL): This group will keep medical appointments information and routine procedure in the hospital.
Will be included in study the individuals with morbid obesity who do not have contraindications to practice low-intensity exercise.
Exclusion criteria are contraindications to physical exercise, individuals with cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association), orthopedic problems, severe retinopathy, severe neuropathy, drug addicts and severe mental illness, metabolic or blood pressure decompensated.
- Conditions
- Morbid Obesity
- Being tested
- G1 -Exercise, G2- Exercise and Lifestyle, G3- Control
- Keywords
- Exercise, Morbidity Obesity
- 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.
G1 -ExerciseOther
20 minutes of aerobic exercises of low intensity (2-4 on the Borg scale) in the rhythm of different songs that encourage their implementation. After these exercises will be performed five minutes of stretching exercises.
Furthermore the similar treatment to G3.
G2- Exercise and LifestyleBehavioural
Exercise more techniques of cognitive behavioral therapy based on principles of learning, in order to promote and maintain new healthy behaviors and the reduction or elimination of undesirable conduct.
Furthermore the similar treatment to G3.
G3- ControlOther
Routine treatment in outpatient of bariatric surgery. Consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention.
| Study group | Role | What they receive |
|---|---|---|
| G1- EXERCISE | Experimental | The group will Participate in an physical exercise program twice a week. This program consists of 20 minutes of aerobic exercises of low intensity (2-4 on the Borg scale) in the rhythm of different songs that encourage their implementation. After these exercises will be performed five minutes of stretching exercises. Receives: Other: G1 -Exercise; Other: G3- Control |
| G2- EXERCISE AND LIFESTYLE | Experimental | This groups will receive the same intervention of G1 group, associated with the weekly group with a psychologist.
These groups worked techniques of cognitive behavioral therapy based on principles of learning, in order to promote and maintain new healthy behaviors, as well as the reduction or elimination of undesirable conduct. Receives: Behavioral: G2- Exercise and Lifestyle; Other: G3- Control |
| G3- CONTROL | Active comparator | This group will keep the routine treatment in outpatient of bariatric surgery. This treatment consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention. Receives: Other: G3- Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight Loss
Measured: baseline and Four months
Secondary outcomes (2)
Metabolic Parameters (composite)
Metabolic parameters will be evaluated using total cholesterol, HDL, triglycerides and glucose (Assessment at baseline and 4 months).
Measured: baseline and Four months
Six minute walk test (6MWT)
Functional capacity will be evaluated using the six minute walk test (6MWT)
Measured: baseline and Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startAug 2010
- Primary completionNov 2015
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manoel R Trindade, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406976
- Sponsor's protocol ID
- 10-0328
- Status last verified
- Mar 2017
- First submitted
- 30 Mar 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Marcon ER, Gus I, Neumann CR. [Impact of a minimum program of supervised exercises in the cardiometabolic risk in patients with morbid obesity]. Arq Bras Endocrinol Metabol. 2011 Jun;55(5):331-8. doi: 10.1590/s0004-27302011000500006. Portuguese.
PubMed 21881816Fonseca Jr SJ, et al. Exercício Físico e Obesidade Mórbida: Uma Revisão Sistemática. ABCD Arq Bras Cir Dig 2013;26(Suplemento 1):67-73
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity
- ClinicalTrials.gov ID
- NCT02406976
- Acronym / sponsor ID
- 10-0328
- Conditions
- Morbid Obesity
- Keywords
- Exercise, Morbidity Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2018 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- 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.
This objective study to verify the effect of physical training with and without behavioral cognitive therapy, compared with controls, in functional capacity and cardio-metabolic profile in individuals with morbidly obese
Detailed description
This study is a Randomized Clinical Trial, with individuals with morbid obesity, and will be consists of 3 groups:
- Group 1 (G1 EXERCISE): This group will participate in an physical exercise program twice a week in hospital.
- Group 2 (G2 - LIFESTYLE AND EXERCISE): This groups will receive the same G1 intervention associated with a weekly group followed up with techniques of cognitive behavioral therapy with a psychologist
- Group 3 (G3 - CONTROL): This group will keep medical appointments information and routine procedure in the hospital.
Will be included in study the individuals with morbid obesity who do not have contraindications to practice low-intensity exercise.
Exclusion criteria are contraindications to physical exercise, individuals with cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association), orthopedic problems, severe retinopathy, severe neuropathy, drug addicts and severe mental illness, metabolic or blood pressure decompensated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G1- EXERCISE | Experimental | Other: G1 -Exercise, Other: G3- ControlThe group will Participate in an physical exercise program twice a week. This program consists of 20 minutes of aerobic exercises of low intensity (2-4 on the Borg scale) in the rhythm of different songs that encourage their implementation. After these exercises will be performed five minutes of stretching exercises. |
| G2- EXERCISE AND LIFESTYLE | Experimental | Behavioral: G2- Exercise and Lifestyle, Other: G3- ControlThis groups will receive the same intervention of G1 group, associated with the weekly group with a psychologist. These groups worked techniques of cognitive behavioral therapy based on principles of learning, in order to promote and maintain new healthy behaviors, as well as the reduction or elimination of undesirable conduct. |
| G3- CONTROL | Active comparator | Other: G3- ControlThis group will keep the routine treatment in outpatient of bariatric surgery. This treatment consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with morbid obesity
- Individuals do not have contraindications to practice low-intensity exercise.
Key exclusion criteria (7 listed)
- Contraindications to physical exercise
- Cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association)
- Orthopedic problems
- Severe retinopathy
- Severe neuropathy
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 |
|---|---|---|
| G1 -Exercise20 minutes of aerobic exercises of low intensity (2-4 on the Borg scale) in the rhythm of different songs that encourage their implementation. After these exercises will be performed five minutes of stretching exercises. Furthermore the similar treatment to G3. | Other | G1- EXERCISE |
| G2- Exercise and LifestyleExercise more techniques of cognitive behavioral therapy based on principles of learning, in order to promote and maintain new healthy behaviors and the reduction or elimination of undesirable conduct. Furthermore the similar treatment to G3. | Behavioural | G2- EXERCISE AND LIFESTYLE |
| G3- ControlRoutine treatment in outpatient of bariatric surgery. Consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention. | Other | G1- EXERCISE, G2- EXERCISE AND LIFESTYLE, G3- CONTROL |
Primary outcome
Change in Weight Loss
Time frame: baseline and Four months
2 secondary outcomes
Metabolic Parameters (composite)
Time frame: baseline and Four months
Six minute walk test (6MWT)
Time frame: baseline and Four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Background: PubMed 21881816Marcon ER, Gus I, Neumann CR. [Impact of a minimum program of supervised exercises in the cardiometabolic risk in patients with morbid obesity]. Arq Bras Endocrinol Metabol. 2011 Jun;55(5):331-8. doi: 10.1590/s0004-27302011000500006. Portuguese.
- BackgroundFonseca Jr SJ, et al. Exercício Físico e Obesidade Mórbida: Uma Revisão Sistemática. ABCD Arq Bras Cir Dig 2013;26(Suplemento 1):67-73
- 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.
Manoel R Trindade, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G1 -Exercise and G2- Exercise and Lifestyle in people with Morbid Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 7 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 14 Mar 2017. 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 Brazil. 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?
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 Weight Loss (time frame: baseline and Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02406976, which also lists 2 linked publications.
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 14 Mar 2017.