Bariatric Surgery PatientsBariOptimizeNCT05632718
Is Resistance Exercise More Effective Than Endurance in Reducing Obesity Relapse in Post-bariatric Surgery Patients
A study testing Exercise in people with Bariatric Surgery Patients, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The goal of this clinical trial is to compare the effects of resistance exercise and endurance in post-bariatric surgery patients with insuficcient weight loss. The main question it aims to answer is: Is resistance exercise more effective than endurance exercise in preventing obesity relapse in post-bariatric surgery… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Patients
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Dec 2022to 30 Apr 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years (until the end of intervention)
- Having performed primary bariatric surgery (gastric sleeve or RYGB methods) in the prior 18 to 24 months in S. João Hospital center.
- Willing to participate and commit to intervention
Who cannot join
- Already taking part in a structured exercise programme.
- Presenting health condition contraindicating exercise practice
- Inability to commit with intervention
Trial locations and contacts
1 site in 1 country.
Hélder R Fonseca, PhD contact
Portugal1 site, 1 recruiting
- Recruiting
FADEUP
Porto, 4200-450
Hélder R Fonseca, PhD, hfonseca@fade.up.pt
About this study
Official title: Searching for the Optimal Exercise Training Regimen for Reducing Obesity Relapse in Post Bariatric Surgery Patients With Insufficient Weight Loss - BariOPTIMIZE Randomized Parallel-arm Clinical Trial
The goal of this clinical trial is to compare the effects of resistance exercise and endurance in post-bariatric surgery patients with insuficcient weight loss. The main question it aims to answer is:
- Is resistance exercise more effective than endurance exercise in preventing obesity relapse in post-bariatric surgery patients with insuficcient weight loss?
- Is resistance exercise more effective than endurance exercise in increasing resting metabolic rate in post-bariatric surgery patients with insuficcient weight loss?
Read more
Participants will be randomly assigned to one of the following groups:
- Resistance group: performing resistance exercise-training for 16 weeks
- Endurace group: performing endurance exercise-training for 16 weeks
- Control group: no intervention / standard medical care
Read the detailed description
As lean body mass losses following bariatric surgery (BS) negatively affect resting metabolic rate (RMR), metabolic regulation and physical function, the researchers hypothesize that resistance exercise (REx) could more effectively prevent obesity relapse following BS. Also, the increased mechanical loading on lumbar spine intervertebral discs is associated with an ampered spinal health and low pressure pain threshold sensitvity in these patients. The main purpose of this project is to determine which exercise mode is best suited to prevent obesity and increase RMR of post-BS patients with insufficient weight loss.
To accomplish this, the researchers will perform a single center 3-parallel-arm open-label randomized clinical trial to determine if resistance exercise is superior to endurance exercise in reducing obesity relapse in post-BS patients with insufficient weight loss.
Aditionally we aim to investigate if resistance exercise is more effective than endurance exercise in producing changes in pressure pain threshold, spine mobility and thoracolumbar strength in post-BS patients with insufficient weight loss.
Patients will be enrolled in 4 (possibly 5) consecutive cohorts of n=20. These must be between 18 and 65 years old and have performed bariatric surgery in the prior 18 to 24 months. Participants will be randomly assigned one of three groups: control (CON), resistance exercise (REx) and endurance exercise (EEx), while the latter two will be enrolling exercise-training programs. All the groups will be assessed in two moments: baseline and 16 weeks (end of exercise programme). Both the training sessions and the assessments will be performed at Porto Faculty of Sports (FADEUP).
The study is expected to run for 2.5 years while including 5 cohorts of patients.
Participants will be the chance to participate for free in exercise sessions (REx, EEx ) and to have free access to the results of health evaluations performed. Main risks for participants in the study will be the potential adverse events associated with exercise or physical evaluations and the burden of time spent in exercise sessions and evaluations.
- Conditions
- Bariatric Surgery Patients
- Being tested
- Exercise
- Keywords
- Bariatric surgery, Resistance exercise, Resting metabolic rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Resistance and endurance supervised exercise-training. The training programme will last for 16 weeks. Training sessions will be held at Porto Faculty of Sports, 3 times per week with the duration of 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Resistance group | Experimental | 16 weeks of resistance exercise-training. Receives: Other: Exercise |
| Endurance group | Experimental | 16 weeks of endurance exercise-training. Receives: Other: Exercise |
| Control group | No intervention | Does not enrole in exercise-training programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent fat mass
Change in fat mass percentage measured by DXA at 0 and 16 weeks (pre and post intervention)
Measured: 16 weeks
Resting metabolic rate
Change in resting metabolic rate measured by indirect calorimetry at 0 and 16 weeks (pre and post intervention)
Measured: 16 weeks
Secondary outcomes (4)
Pressure Pain Threshold lumbar paraspinal
Change in Pressure Pain Threshold at 0 and 16 weeks (pre and post intervention)
Measured: 16 weeks
Lean body mass
Change in lean body mass measured by DXA at 0 and 16 weeks (pre and post intervention)
Measured: 16 weeks
Spine mobility, posture and stability
Change in spine mobility, posture and stability measured by algometer and Spinal Mouse and at 0 and 16 weeks (pre and post intervention)
Measured: 16 weeks
Trunk muscle strength
Change in trunk muscle strength measured by dynamometry and expressed as peak torque relative to body weight at 0 and 16 weeks (pre and post intervention)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start15 Dec 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery PatientsStudies 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
- Model description
- Single center 3-parallel-arm open-label randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Research Centre in Physical Activity, Health and Leisure, Portugal
- Responsible party
- Principal investigator, Tiago Montanha, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632718
- Sponsor's protocol ID
- CIAFEL2022
- Acronym
- BariOptimize
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for the Optimal Exercise Training Regimen for Reducing Obesity Relapse in Post Bariatric Surgery Patients With Insufficient Weight Loss - BariOPTIMIZE Randomized Parallel-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05632718
- Acronym / sponsor ID
- BariOptimize / CIAFEL2022
- Conditions
- Bariatric Surgery Patients
- Keywords
- Bariatric surgery, Resistance exercise, Resting metabolic rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Research Centre in Physical Activity, Health and Leisure, Portugal
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 1 Dec 2022 (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.
The goal of this clinical trial is to compare the effects of resistance exercise and endurance in post-bariatric surgery patients with insuficcient weight loss. The main question it aims to answer is:
- Is resistance exercise more effective than endurance exercise in preventing obesity relapse in post-bariatric surgery patients with insuficcient weight loss?
- Is resistance exercise more effective than endurance exercise in increasing resting metabolic rate in post-bariatric surgery patients with insuficcient weight loss?
Participants will be randomly assigned to one of the following groups:
- Resistance group: performing resistance exercise-training for 16 weeks
- Endurace group: performing endurance exercise-training for 16 weeks
- Control group: no intervention / standard medical care
Detailed description
As lean body mass losses following bariatric surgery (BS) negatively affect resting metabolic rate (RMR), metabolic regulation and physical function, the researchers hypothesize that resistance exercise (REx) could more effectively prevent obesity relapse following BS. Also, the increased mechanical loading on lumbar spine intervertebral discs is associated with an ampered spinal health and low pressure pain threshold sensitvity in these patients. The main purpose of this project is to determine which exercise mode is best suited to prevent obesity and increase RMR of post-BS patients with insufficient weight loss.
To accomplish this, the researchers will perform a single center 3-parallel-arm open-label randomized clinical trial to determine if resistance exercise is superior to endurance exercise in reducing obesity relapse in post-BS patients with insufficient weight loss.
Aditionally we aim to investigate if resistance exercise is more effective than endurance exercise in producing changes in pressure pain threshold, spine mobility and thoracolumbar strength in post-BS patients with insufficient weight loss.
Patients will be enrolled in 4 (possibly 5) consecutive cohorts of n=20. These must be between 18 and 65 years old and have performed bariatric surgery in the prior 18 to 24 months. Participants will be randomly assigned one of three groups: control (CON), resistance exercise (REx) and endurance exercise (EEx), while the latter two will be enrolling exercise-training programs. All the groups will be assessed in two moments: baseline and 16 weeks (end of exercise programme). Both the training sessions and the assessments will be performed at Porto Faculty of Sports (FADEUP).
The study is expected to run for 2.5 years while including 5 cohorts of patients.
Participants will be the chance to participate for free in exercise sessions (REx, EEx ) and to have free access to the results of health evaluations performed. Main risks for participants in the study will be the potential adverse events associated with exercise or physical evaluations and the burden of time spent in exercise sessions and evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single center 3-parallel-arm open-label randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Resistance group | Experimental | Other: Exercise16 weeks of resistance exercise-training. |
| Endurance group | Experimental | Other: Exercise16 weeks of endurance exercise-training. |
| Control group | No intervention | –Does not enrole in exercise-training programme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years (until the end of intervention)
- Having performed primary bariatric surgery (gastric sleeve or RYGB methods) in the prior 18 to 24 months in S. João Hospital center.
- Willing to participate and commit to intervention
Key exclusion criteria (3 listed)
- Already taking part in a structured exercise programme.
- Presenting health condition contraindicating exercise practice
- Inability to commit with intervention
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 |
|---|---|---|
| ExerciseResistance and endurance supervised exercise-training. The training programme will last for 16 weeks. Training sessions will be held at Porto Faculty of Sports, 3 times per week with the duration of 1 hour. | Other | Endurance group, Resistance group |
Primary outcome
Percent fat mass
Time frame: 16 weeks
Change in fat mass percentage measured by DXA at 0 and 16 weeks (pre and post intervention)
Resting metabolic rate
Time frame: 16 weeks
Change in resting metabolic rate measured by indirect calorimetry at 0 and 16 weeks (pre and post intervention)
4 secondary outcomes
Pressure Pain Threshold lumbar paraspinal
Time frame: 16 weeks
Lean body mass
Time frame: 16 weeks
Spine mobility, posture and stability
Time frame: 16 weeks
Trunk muscle strength
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Hélder R Fonseca, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Bariatric Surgery Patients, run by Universidade do Porto at 1 site in Portugal.
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 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 3 Jan 2024. 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 Portugal. 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?
Contact Tiago L Montanha, MSc (+351 22 04 25 200, lmontanha@fade.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent fat mass (time frame: 16 weeks). The study lists 2 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 3 Jan 2024.