Bariatric Surgery CandidateBariPrehabNCT05235945
The Effect of Exercise in Patients Awaiting Bariatric Surgery
A study testing Online exercise intervention in people with Bariatric Surgery Candidate and Obesity, run by University College, London at 1 site in United Kingdom.
Trial summary
The aim of this project is to understand the impact of a four week preoperative exercise programme on fitness and metabolic rate and weight before surgery. A multi-site randomised trial sponsored by UCL, recruiting patients awaiting bariatric surgery for obesity at University College London Hospital (UCLH)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity
- What is being tested?
- Online exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults, aged 18 and above.
- Patients enrolled in the UCLH, Homerton or Whittington Hospitals bariatric surgery program with BMI > 30 kg/m2
- ≤5 % variation in body weight over preceding 3 months.
- Willing and able to comply with the trial protocol.
- Willing and able to provide written informed consent
- Male or Female
Who cannot join
- Pregnant or lactating mothers.
- Weight over 180 kg (due to weight restrictions of equipment used).
- Current use of betablockade.
- Concurrent participation in other clinical intervention trial.
- Clinically significant medical co-morbidities (e.g. uncontrolled hypertension, unstable cardiovascular disease) that could place at risk of an adverse response to exercise.
- History of atrial fibrillation, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London
London, wC1E6BT
Pushpsen Joshi, uclh.randd@nhs.net
Belinda Durey
About this study
Official title: The Effect of a Preoperative Exercise Programme on Cardiorespiratory Fitness, Resting Metabolic Rate and Autonomic Control in Patients With Severe Obesity Awaiting Bariatric Surgery
The aim of this project is to understand the impact of a four week preoperative exercise programme on fitness and metabolic rate and weight before surgery.
A multi-site randomised trial sponsored by UCL, recruiting patients awaiting bariatric surgery for obesity at University College London Hospital (UCLH), Whittington Health NHS Trust, or Homerton University Hospital NHS Foundation Trust.
The investigators will measure fitness, metabolic rate, body weight/composition and grip strength in all participants, before and after a four-week supervised physical activity intervention. The investigators will also interview participants about their participation in the study in regard to the planning of future studies.
Read the detailed description
The aim of this project is to understand the impact of a structured personalised 4-week exercise programme on resting fitness and metabolic rate in patients awaiting bariatric surgery for obesity. The hypothesis is that patients awaiting bariatric surgery who undertake a preoperative exercise programme will experience attenuated changes in functional capacity (fitness) and metabolic rate compared with usual care (no exercise programme) along with alterations in autonomic control.
The investigators propose a randomised controlled trial that will recruit 48 patients with obesity scheduled for bariatric surgery at UCLH, Whittington Health NHS Trust, and Homerton University Hospital NHS Foundation Trust. Participants will be randomly assigned to either usual care (exercise advice only) or combination exercise intervention group, during a four-week lead up to surgery, on a 1:1 basis.
Participants randomised to the intervention group will participate in 7 physiologist-led exercise sessions online and also be instructed to complete 7 self-led 30-minute exercise sessions over the four-week intervention period. This equates to a total of 14 exercise sessions across the four-week (28 day) intervention. Additionally, participants will be encouraged to be physically active on as many days as possible, in bouts of 10-minutes or more. The programme is designed to meet the National Physical Activity Guidelines of at least 150 minutes of low-moderate or 75 minutes of vigorous PA per week, or a combination of the two.
The investigators will measure physical fitness, metabolic rate, and how the heart responds to hormonal changes (the sympathetic nervous system) in all participants, before and after the four-week study period. The investigators will also interview participants about their participation in the study in regard to the planning of future studies.
Baseline data collection will occur at least six weeks prior to surgery as detailed below. Both groups will be invited to attend follow-up assessment at 4 weeks where they will undergo the same series of tests. The total duration of participation will be approximately 4 weeks.
- Conditions
- Bariatric Surgery Candidate, Obesity
- Being tested
- Online exercise intervention
- Keywords
- exercise, fitness, pre-operative, prehabilitation, bariatric, obesity, surgery
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online exercise interventionBehavioural
Described in arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| Online exercise intervention | Experimental | A four-week preoperative physical activity intervention, involving a combination of supervised and unsupervised (live or pre-recorded), online exercise sessions. These sessions will be designed to meet the National physical activity guidelines (2020) of at least 150 minutes of low-moderate or 75 minutes of vigorous physical activity per week (or a combination of the two). The intervention will involve moderate intensity activities that aim to increase or maintain muscle strength (resistance training) as well as short bouts of vigorous aerobic exercise, using major muscle groups in the lower and upper body. Receives: Behavioral: Online exercise intervention |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitness (VO2 in ml/kg/min)
VO2 (at anaerobic threshold (AT) and peak exercise) using gas-analysed cardiopulmonary exercise testing.
Measured: 4 weeks
Secondary outcomes (7)
Resting metabolic rate (VO2 in ml/kg/min)
Energy expenditure at rest, collected using respiratory gas-analysis via metabolic cart.
Measured: 4 weeks
Maximal grip strength (kg)
Hand grip dynamometry, best of three repeat measures on each hand (left and right)
Measured: 4 weeks
Body mass (kg)
Body mass in kilograms using body weight scales.
Measured: 4 weeks
Autonomic control (heart-rate variability)
Heart-rate variability measured via electrocardiogram (ECG), assessing the variability between heart beats at rest, resting heart-rate, and exercise heart-rate response
Measured: 4 weeks
Participant satisfaction feedback
Participants satisfaction/acceptability of the mode of delivery and content of the intervention will be collected via semi-structured interviews. Participants will be asked how much they liked specific aspects of the program, and will answer using a 5-point Likert scale. They will also be asked to provide general feedback, and answers related to behaviour change using open-ended questions.
Measured: 4 weeks
Body composition (%FM, %FFM)
Percent fat mass and percent fat-free mass using bioelectric impedance analysis (BIA)
Measured: 4 weeks
Physical activity patterns
7-day physical activity patterns (sedentary time, low, moderate and vigorous physical activity) measured using accelerometer data
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start16 Jun 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Belinda Durey, Principal investigator, UCL, UniSA and UNSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235945
- Sponsor's protocol ID
- 130811
- Other IDs
- 273319, 21/EM/0230
- Acronym
- BariPrehab
- Status last verified
- May 2025
- First submitted
- 12 Jan 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summary format only, Access to IPD will be reviewed on a case-by-case basis following requests.
Publications
Durey BJ, Fritche D, Martin DS, Best LMJ. The Effect of Pre-operative Exercise Intervention on Patient Outcomes Following Bariatric Surgery: a Systematic Review and Meta-analysis. Obes Surg. 2022 Jan;32(1):160-169. doi: 10.1007/s11695-021-05743-w. Epub 2021 Oct 20.
PubMed 34671929Sardeli AV, Komatsu TR, Mori MA, Gaspari AF, Chacon-Mikahil MPT. Resistance Training Prevents Muscle Loss Induced by Caloric Restriction in Obese Elderly Individuals: A Systematic Review and Meta-Analysis. Nutrients. 2018 Mar 29;10(4):423. doi: 10.3390/nu10040423.
PubMed 29596307Durey BJ, Coates AM, Davison K, Tarca B, Mok J, Parmar CD, Fernandez-Munoz N, Burton K, Tetlow N, Dewar AL, Adeleke MO, Lugg Z, Colbert J, Martin DS. Evaluating the Impact of Telehealth Exercise Prehabilitation on Cardiometabolic Health in Bariatric Surgery Candidates: Protocol for the BARI-Prehab Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 13;14:e77538. doi: 10.2196/77538.
PubMed 41232096
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Preoperative Exercise Programme on Cardiorespiratory Fitness, Resting Metabolic Rate and Autonomic Control in Patients With Severe Obesity Awaiting Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05235945
- Acronym / sponsor ID
- BariPrehab / 130811
- Conditions
- Bariatric Surgery Candidate, Obesity
- Keywords
- exercise, fitness, pre-operative, prehabilitation, bariatric, obesity, surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Feb 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 aim of this project is to understand the impact of a four week preoperative exercise programme on fitness and metabolic rate and weight before surgery.
A multi-site randomised trial sponsored by UCL, recruiting patients awaiting bariatric surgery for obesity at University College London Hospital (UCLH), Whittington Health NHS Trust, or Homerton University Hospital NHS Foundation Trust.
The investigators will measure fitness, metabolic rate, body weight/composition and grip strength in all participants, before and after a four-week supervised physical activity intervention. The investigators will also interview participants about their participation in the study in regard to the planning of future studies.
Detailed description
The aim of this project is to understand the impact of a structured personalised 4-week exercise programme on resting fitness and metabolic rate in patients awaiting bariatric surgery for obesity. The hypothesis is that patients awaiting bariatric surgery who undertake a preoperative exercise programme will experience attenuated changes in functional capacity (fitness) and metabolic rate compared with usual care (no exercise programme) along with alterations in autonomic control.
The investigators propose a randomised controlled trial that will recruit 48 patients with obesity scheduled for bariatric surgery at UCLH, Whittington Health NHS Trust, and Homerton University Hospital NHS Foundation Trust. Participants will be randomly assigned to either usual care (exercise advice only) or combination exercise intervention group, during a four-week lead up to surgery, on a 1:1 basis.
Participants randomised to the intervention group will participate in 7 physiologist-led exercise sessions online and also be instructed to complete 7 self-led 30-minute exercise sessions over the four-week intervention period. This equates to a total of 14 exercise sessions across the four-week (28 day) intervention. Additionally, participants will be encouraged to be physically active on as many days as possible, in bouts of 10-minutes or more. The programme is designed to meet the National Physical Activity Guidelines of at least 150 minutes of low-moderate or 75 minutes of vigorous PA per week, or a combination of the two.
The investigators will measure physical fitness, metabolic rate, and how the heart responds to hormonal changes (the sympathetic nervous system) in all participants, before and after the four-week study period. The investigators will also interview participants about their participation in the study in regard to the planning of future studies.
Baseline data collection will occur at least six weeks prior to surgery as detailed below. Both groups will be invited to attend follow-up assessment at 4 weeks where they will undergo the same series of tests. The total duration of participation will be approximately 4 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Online exercise intervention | Experimental | Behavioral: Online exercise interventionA four-week preoperative physical activity intervention, involving a combination of supervised and unsupervised (live or pre-recorded), online exercise sessions. These sessions will be designed to meet the National physical activity guidelines (2020) of at least 150 minutes of low-moderate or 75 minutes of vigorous physical activity per week (or a combination of the two). The intervention will involve moderate intensity activities that aim to increase or maintain muscle strength (resistance training) as well as short bouts of vigorous aerobic exercise, using major muscle groups in the lower and upper body. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults, aged 18 and above.
- Patients enrolled in the UCLH, Homerton or Whittington Hospitals bariatric surgery program with BMI > 30 kg/m2
- ≤5 % variation in body weight over preceding 3 months.
- Willing and able to comply with the trial protocol.
- Willing and able to provide written informed consent
Key exclusion criteria (6 listed)
- Pregnant or lactating mothers.
- Weight over 180 kg (due to weight restrictions of equipment used).
- Current use of betablockade.
- Concurrent participation in other clinical intervention trial.
- Clinically significant medical co-morbidities (e.g. uncontrolled hypertension, unstable cardiovascular disease) that could place at risk of an adverse response to 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 |
|---|---|---|
| Online exercise interventionDescribed in arm descriptions | Behavioural | Online exercise intervention |
Primary outcome
Fitness (VO2 in ml/kg/min)
Time frame: 4 weeks
VO2 (at anaerobic threshold (AT) and peak exercise) using gas-analysed cardiopulmonary exercise testing.
7 secondary outcomes
Resting metabolic rate (VO2 in ml/kg/min)
Time frame: 4 weeks
Maximal grip strength (kg)
Time frame: 4 weeks
Body mass (kg)
Time frame: 4 weeks
Autonomic control (heart-rate variability)
Time frame: 4 weeks
Participant satisfaction feedback
Time frame: 4 weeks
Body composition (%FM, %FFM)
Time frame: 4 weeks
Physical activity patterns
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Results publication: PubMed 34671929Durey BJ, Fritche D, Martin DS, Best LMJ. The Effect of Pre-operative Exercise Intervention on Patient Outcomes Following Bariatric Surgery: a Systematic Review and Meta-analysis. Obes Surg. 2022 Jan;32(1):160-169. doi: 10.1007/s11695-021-05743-w. Epub 2021 Oct 20.
- Results publication: PubMed 29596307Sardeli AV, Komatsu TR, Mori MA, Gaspari AF, Chacon-Mikahil MPT. Resistance Training Prevents Muscle Loss Induced by Caloric Restriction in Obese Elderly Individuals: A Systematic Review and Meta-Analysis. Nutrients. 2018 Mar 29;10(4):423. doi: 10.3390/nu10040423.
- Derived from this study: PubMed 41232096Durey BJ, Coates AM, Davison K, Tarca B, Mok J, Parmar CD, Fernandez-Munoz N, Burton K, Tetlow N, Dewar AL, Adeleke MO, Lugg Z, Colbert J, Martin DS. Evaluating the Impact of Telehealth Exercise Prehabilitation on Cardiometabolic Health in Bariatric Surgery Candidates: Protocol for the BARI-Prehab Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 13;14:e77538. doi: 10.2196/77538.
- Individual participant dataSharing planned: No. Summary format only, Access to IPD will be reviewed on a case-by-case basis following requests.
Related trials for Bariatric Surgery Candidate
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Enrolling by invitationObservational study
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
Obese, Healthy
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
Recruiting
Autonomic Neural Blockade in Bariatric Surgery
Bariatric Surgery Candidate, Pain, Postoperative
Recruiting
Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery
Obesity, Bariatric Surgery Candidate
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.
Belinda Durey principal investigator
UCL, UniSA and UNSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online exercise intervention in people with Bariatric Surgery Candidate and Obesity, run by University College, London at 1 site in United Kingdom.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 May 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Martin (+44 1752 600600, daniel.martin@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitness (VO2 in ml/kg/min) (time frame: 4 weeks). 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 NCT05235945, which also lists 3 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 May 2025.