Bariatric Surgery CandidateACTIBARIANCT05050968
Physical Activity and Bariatric Surgery
A study testing Physical activity in people with Bariatric Surgery Candidate, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2018to 7 Jun 2021
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women between 18 and 55 years old
- undergoing bariatric surgery (a "bypass gastric" or a "sleeve")
- not practicing a supervised physical activity
- having read and signed an informed consent prior to the start of the trial
- being affiliated to a social security system
Who cannot join
- Women with a contraindication to physical activity
- any medical contraindication to the practice of stress tests.
- unable to go to the hospital regularly
- having a significant functional limitation that does not allow her to perform the 6-minute walk test
- with an intellectual disability and/or psychiatric illness
- does not speak and/or understand French
Show all 9Show fewer
- pregnant woman
- under guardianship or curatorship
- participating in another clinical research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Controlled Physical Activity on the Fitness, Body Composition and Quality of Life of Obese Women Undergoing Bariatric Surgery
Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice.
So, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.
Read the detailed description
Upon hospitalization for their bariatric surgery (bypass or sleeve), subjects will sign their informed consent and be included in the study. Six weeks' post-surgery, the subjects will be randomized in one of the 2 groups (Control group CG or Adapted Physical Activity group APAG). Patients in both groups will have 3 postoperative visits one at 6 weeks (V1), one at 18 weeks (V2) and one at 30 weeks (V3). During these visits, they will undergo the same assessments (body composition, physical condition, quality of life). Patients in the CG will receive standard hospital management. Patients in APAG will follow the same management and will also follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups.
The subjects will evaluate during each visit V1, V2 and V3:
- body composition,
- physical condition,
- quality of life
- daily physical activity
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Physical activity
- Keywords
- Physical activity, Bariatric Surgery, Physical Fitness, Quality of life, Body Composition
- 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 activityOther
Between V1 and V2 (i.e. 12 weeks), the APAG (Adapted Physical Activity Group) will participate at a physical training program, 3 sessions of 1h30 per week consisting of endurance activities (60-75% of VO2 peak) and muscle strengthening while the CG will not perform any controlled physical training program. Then, between V2 and V3, no APA (Adapted Physical Activity) program will be offered to both groups.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity Group | Experimental | Patients will follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups. Receives: Other: Physical activity |
| Control group | No intervention | Patients will receive standard hospital management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen consumption (VO2 max)
The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load
Measured: Week 6
Maximum oxygen consumption (VO2 max)
The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load
Measured: Week 18
Maximum oxygen consumption (VO2 max)
The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load
Measured: Week 30
Secondary outcomes (30)
Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)
QoL will be assessed using a simplified version of the French obesity-specific QoL questionnaire developed by Ziegler et al. Each participant will be asked to evaluate 14 statements about their life on a 4-point Likert scale (with 1 representing total disagreement and 4 representing total agreement). The 14 statements (eg, "Because of my weight, I have trouble to dress or undress") will equally be divided between physical aspects of life and psychosocial aspects of life. A French obesity-specific QoL questionnaire will be used to calculate the participants' physical dimension of QoL scores and psychoso-cial dimension of QoL scores by summing the points for each relevant item (range: 7-28 points). The total score will also be calculated (range: 14-56 points). The higher the scores, the better the QoL.
Measured: Week 6
Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)
QoL will be assessed using a simplified version of the French obesity-specific QoL questionnaire developed by Ziegler et al. Each participant will be asked to evaluate 14 statements about their life on a 4-point Likert scale (with 1 representing total disagreement and 4 representing total agreement). The 14 statements (eg, "Because of my weight, I have trouble to dress or undress") will equally be divided between physical aspects of life and psychosocial aspects of life. A French obesity-specific QoL questionnaire will be used to calculate the participants' physical dimension of QoL scores and psychoso-cial dimension of QoL scores by summing the points for each relevant item (range: 7-28 points). The total score will also be calculated (range: 14-56 points). The higher the scores, the better the QoL.
Measured: Week 18
Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)
QoL will be assessed using a simplified version of the French obesity-specific QoL questionnaire developed by Ziegler et al. Each participant will be asked to evaluate 14 statements about their life on a 4-point Likert scale (with 1 representing total disagreement and 4 representing total agreement). The 14 statements (eg, "Because of my weight, I have trouble to dress or undress") will equally be divided between physical aspects of life and psychosocial aspects of life. A French obesity-specific QoL questionnaire will be used to calculate the participants' physical dimension of QoL scores and psychoso-cial dimension of QoL scores by summing the points for each relevant item (range: 7-28 points). The total score will also be calculated (range: 14-56 points). The higher the scores, the better the QoL.
Measured: Week 30
Walking distance
The walking distance (meters) will be evaluated during the 6 minutes walk test
Measured: Week 6
Walking distance
The walking distance (meters) will be evaluated during the 6 minutes walk test
Measured: Week 18
Walking distance
The walking distance (meters) will be evaluated during the 6 minutes walk test
Measured: Week 30
Heart rate
The heart rate (beats/min) will be evaluated during the 6 minutes walk test
Measured: Week 6
Heart rate
The heart rate (beats/min) will be evaluated during the 6 minutes walk test
Measured: Week 18
Heart rate
The heart rate (beats/min) will be evaluated during the 6 minutes walk test
Measured: Week 30
Perception of the effort
This will be evaluated with a Borg scale (the minimum score is 0 = no exertion and the maximal 10 = maximal exertion) at the end of the 6-minutes walk test.
Measured: Week 6
Perception of the effort
This will be evaluated with a Borg scale (the minimum score is 0 = no exertion and the maximal 10 = maximal exertion) at the end of the 6-minutes walk test.
Measured: Week 18
Perception of the effort
This will be evaluated with a Borg scale (the minimum score is 0 = no exertion and the maximal 10 = maximal exertion) at the end of the 6-minutes walk test.
Measured: Week 36
Maximum voluntary force of the quadriceps
The maximum voluntary isometric strength of the knee extensors (strength of quadriceps in kilograms) will be measured with a MicroFET2 handheld dynamometer.
Each participant's lower extremity could be placed in a position a knee flexion of 90 degrees. They will be asked to apply maximal force against the dynamometer held by the physical therapist. Before the test, the participants will be given a standard instruction of "push as hard as you can." Encouragement to apply maximal effort will also be given during the test. Each participant will be instructed to exert maximal strength for 3-5 seconds until the examiner instructed the patient to relax.
Measured: week 6
Maximum voluntary force of the quadriceps
The maximum voluntary isometric strength of the knee extensors (strength of quadriceps in kilograms) will be measured with a MicroFET2 handheld dynamometer.
Each participant's lower extremity could be placed in a position a knee flexion of 90 degrees. They will be asked to apply maximal force against the dynamometer held by the physical therapist. Before the test, the participants will be given a standard instruction of "push as hard as you can." Encouragement to apply maximal effort will also be given during the test. Each participant will be instructed to exert maximal strength for 3-5 seconds until the examiner instructed the patient to relax.
Measured: week 18
Maximum voluntary force of the quadriceps
The maximum voluntary isometric strength of the knee extensors (strength of quadriceps in kilograms) will be measured with a MicroFET2 handheld dynamometer.
Each participant's lower extremity could be placed in a position a knee flexion of 90 degrees. They will be asked to apply maximal force against the dynamometer held by the physical therapist. Before the test, the participants will be given a standard instruction of "push as hard as you can." Encouragement to apply maximal effort will also be given during the test. Each participant will be instructed to exert maximal strength for 3-5 seconds until the examiner instructed the patient to relax.
Measured: week 30
grip strength
The grip strength will be evaluated with a dynamometer that can be squeezed very hard for 3 seconds. The measurement will be evaluated three times with 30 seconds of recovery and the maximum value will be retained.
Measured: week 6
grip strength
The grip strength will be evaluated with a dynamometer that can be squeezed very hard for 3 seconds. The measurement will be evaluated three times with 30 seconds of recovery and the maximum value will be retained.
Measured: week 18
grip strength
The grip strength will be evaluated with a dynamometer that can be squeezed very hard for 3 seconds. The measurement will be evaluated three times with 30 seconds of recovery and the maximum value will be retained.
Measured: week 30
Body composition
Body composition will be assessed by a body composition analyser in the morning on an empty stomach
Measured: week 6
Body composition
Body composition will be assessed by a body composition analyser in the morning on an empty stomach
Measured: week 18
Body composition
Body composition will be assessed by a body composition analyser in the morning on an empty stomach
Measured: week 30
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:
- Blood Lactate (mmol/L)
Measured: week 6
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:
- Blood glucose (g/L)
Measured: week 6
Hormonal measurements
During the constant workload exercise, blood samples will be taken and hormonal measurements will be made:
- Testosterone (ng/ml)
- Cortisol (ng/ml)
Measured: week 6
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:
- Blood glucose (g/L)
Measured: week 18
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:
- Blood Lactate (mmol/L)
Measured: week 18
Hormonal measurements
During the constant workload exercise, blood samples will be taken and hormonal measurements will be made:
- Testosterone (ng/ml)
- Cortisol (ng/ml)
Measured: week 18
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:
- Blood glucose (g/L)
Measured: week 30
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:
- Blood Lactate (mmol/L)
Measured: week 30
Hormonal measurements
During the constant workload exercise, blood samples will be taken and hormonal measurements will be made:
- Testosterone (ng/ml)
- Cortisol (ng/ml)
Measured: week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start23 Feb 2018
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an open-label, randomized, single-center trial with two groups: an Adapted Physical Activity group and a control group performing no controlled physical activity within each group women undergoing bypass or sleeve surgery
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virgile AMIOT, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050968
- Sponsor's protocol ID
- CHRO-2016-03
- Acronym
- ACTIBARIA
- Status last verified
- Sep 2021
- First submitted
- 22 Jul 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baillot A, Audet M, Baillargeon JP, Dionne IJ, Valiquette L, Rosa-Fortin MM, Abou Chakra CN, Comeau E, Langlois MF. Impact of physical activity and fitness in class II and III obese individuals: a systematic review. Obes Rev. 2014 Sep;15(9):721-39. doi: 10.1111/obr.12171. Epub 2014 Apr 9.
PubMed 24712685Berggren JR, Boyle KE, Chapman WH, Houmard JA. Skeletal muscle lipid oxidation and obesity: influence of weight loss and exercise. Am J Physiol Endocrinol Metab. 2008 Apr;294(4):E726-32. doi: 10.1152/ajpendo.00354.2007. Epub 2008 Feb 5.
PubMed 18252891Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. doi: 10.1097/00005768-200106001-00007.
PubMed 11427763Bond DS, Phelan S, Wolfe LG, Evans RK, Meador JG, Kellum JM, Maher JW, Wing RR. Becoming physically active after bariatric surgery is associated with improved weight loss and health-related quality of life. Obesity (Silver Spring). 2009 Jan;17(1):78-83. doi: 10.1038/oby.2008.501. Epub 2008 Nov 6.
PubMed 18997679Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
PubMed 3920711Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591.
PubMed 27230645Herring LY, Stevinson C, Davies MJ, Biddle SJ, Sutton C, Bowrey D, Carter P. Changes in physical activity behaviour and physical function after bariatric surgery: a systematic review and meta-analysis. Obes Rev. 2016 Mar;17(3):250-61. doi: 10.1111/obr.12361. Epub 2016 Jan 18.
PubMed 26783103
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Controlled Physical Activity on the Fitness, Body Composition and Quality of Life of Obese Women Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05050968
- Acronym / sponsor ID
- ACTIBARIA / CHRO-2016-03
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Physical activity, Bariatric Surgery, Physical Fitness, Quality of life, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 21 Sep 2021 (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.
Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice.
So, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.
Detailed description
Upon hospitalization for their bariatric surgery (bypass or sleeve), subjects will sign their informed consent and be included in the study. Six weeks' post-surgery, the subjects will be randomized in one of the 2 groups (Control group CG or Adapted Physical Activity group APAG). Patients in both groups will have 3 postoperative visits one at 6 weeks (V1), one at 18 weeks (V2) and one at 30 weeks (V3). During these visits, they will undergo the same assessments (body composition, physical condition, quality of life). Patients in the CG will receive standard hospital management. Patients in APAG will follow the same management and will also follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups.
The subjects will evaluate during each visit V1, V2 and V3:
- body composition,
- physical condition,
- quality of life
- daily physical activity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an open-label, randomized, single-center trial with two groups: an Adapted Physical Activity group and a control group performing no controlled physical activity within each group women undergoing bypass or sleeve surgery
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity Group | Experimental | Other: Physical activityPatients will follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups. |
| Control group | No intervention | –Patients will receive standard hospital management |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women between 18 and 55 years old
- undergoing bariatric surgery (a "bypass gastric" or a "sleeve")
- not practicing a supervised physical activity
- having read and signed an informed consent prior to the start of the trial
- being affiliated to a social security system
Key exclusion criteria (9 listed)
- Women with a contraindication to physical activity
- any medical contraindication to the practice of stress tests.
- unable to go to the hospital regularly
- having a significant functional limitation that does not allow her to perform the 6-minute walk test
- with an intellectual disability and/or psychiatric illness
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 activityBetween V1 and V2 (i.e. 12 weeks), the APAG (Adapted Physical Activity Group) will participate at a physical training program, 3 sessions of 1h30 per week consisting of endurance activities (60-75% of VO2 peak) and muscle strengthening while the CG will not perform any controlled physical training program. Then, between V2 and V3, no APA (Adapted Physical Activity) program will be offered to both groups. | Other | Adapted Physical Activity Group |
Primary outcome
Maximum oxygen consumption (VO2 max)
Time frame: Week 6
The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load
Maximum oxygen consumption (VO2 max)
Time frame: Week 18
The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load
Maximum oxygen consumption (VO2 max)
Time frame: Week 30
The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load
30 secondary outcomes
Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)
Time frame: Week 6
Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)
Time frame: Week 18
Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)
Time frame: Week 30
Walking distance
Time frame: Week 6
Walking distance
Time frame: Week 18
Walking distance
Time frame: Week 30
Heart rate
Time frame: Week 6
Heart rate
Time frame: Week 18
Heart rate
Time frame: Week 30
Perception of the effort
Time frame: Week 6
Perception of the effort
Time frame: Week 18
Perception of the effort
Time frame: Week 36
Maximum voluntary force of the quadriceps
Time frame: week 6
Maximum voluntary force of the quadriceps
Time frame: week 18
Maximum voluntary force of the quadriceps
Time frame: week 30
grip strength
Time frame: week 6
grip strength
Time frame: week 18
grip strength
Time frame: week 30
Body composition
Time frame: week 6
Body composition
Time frame: week 18
Body composition
Time frame: week 30
Metabolic measurements
Time frame: week 6
Metabolic measurements
Time frame: week 6
Hormonal measurements
Time frame: week 6
Metabolic measurements
Time frame: week 18
Metabolic measurements
Time frame: week 18
Hormonal measurements
Time frame: week 18
Metabolic measurements
Time frame: week 30
Metabolic measurements
Time frame: week 30
Hormonal measurements
Time frame: week 30
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 21 Sep 2021.
- Background: PubMed 24712685Baillot A, Audet M, Baillargeon JP, Dionne IJ, Valiquette L, Rosa-Fortin MM, Abou Chakra CN, Comeau E, Langlois MF. Impact of physical activity and fitness in class II and III obese individuals: a systematic review. Obes Rev. 2014 Sep;15(9):721-39. doi: 10.1111/obr.12171. Epub 2014 Apr 9.
- Background: PubMed 18252891Berggren JR, Boyle KE, Chapman WH, Houmard JA. Skeletal muscle lipid oxidation and obesity: influence of weight loss and exercise. Am J Physiol Endocrinol Metab. 2008 Apr;294(4):E726-32. doi: 10.1152/ajpendo.00354.2007. Epub 2008 Feb 5.
- Background: PubMed 11427763Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. doi: 10.1097/00005768-200106001-00007.
- Background: PubMed 18997679Bond DS, Phelan S, Wolfe LG, Evans RK, Meador JG, Kellum JM, Maher JW, Wing RR. Becoming physically active after bariatric surgery is associated with improved weight loss and health-related quality of life. Obesity (Silver Spring). 2009 Jan;17(1):78-83. doi: 10.1038/oby.2008.501. Epub 2008 Nov 6.
- Background: PubMed 3920711Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
- Background: PubMed 27230645Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591.
- Background: PubMed 26783103Herring LY, Stevinson C, Davies MJ, Biddle SJ, Sutton C, Bowrey D, Carter P. Changes in physical activity behaviour and physical function after bariatric surgery: a systematic review and meta-analysis. Obes Rev. 2016 Mar;17(3):250-61. doi: 10.1111/obr.12361. Epub 2016 Jan 18.
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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.
Virgile AMIOT, Dr principal investigator
CHR d'Orléans
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 in people with Bariatric Surgery Candidate, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 9 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 21 Sep 2021. 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 France. 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?
Maximum oxygen consumption (VO2 max) (time frame: Week 6). The study lists 3 primary outcomes in all. 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 NCT05050968, which also lists 7 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 21 Sep 2021.