The Effect of Exercise in Patients Awaiting Bariatric Surgery

NCT ID: NCT05235945

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Bariatric Surgery Candidate Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Online exercise intervention

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.

Group Type EXPERIMENTAL

Online exercise intervention

Intervention Type BEHAVIORAL

Described in arm descriptions

Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Online exercise intervention

Described in arm descriptions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Adults, aged 18 and above.
2. Patients enrolled in the UCLH, Homerton or Whittington Hospitals bariatric surgery program with BMI \> 30 kg/m2
3. ≤5 % variation in body weight over preceding 3 months.
4. Willing and able to comply with the trial protocol.
5. Willing and able to provide written informed consent
6. Male or Female

Exclusion Criteria

1. Pregnant or lactating mothers.
2. Weight over 180 kg (due to weight restrictions of equipment used).
3. Current use of betablockade.
4. Concurrent participation in other clinical intervention trial.
5. Clinically significant medical co-morbidities (e.g. uncontrolled hypertension, unstable cardiovascular disease) that could place at risk of an adverse response to exercise.
6. History of atrial fibrillation, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Belinda Durey

Role: PRINCIPAL_INVESTIGATOR

UCL, UniSA and UNSW

Locations

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University College London

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Daniel Martin

Role: CONTACT

+44 1752 600600

Facility Contacts

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Pushpsen Joshi

Role: primary

References

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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.

Reference Type RESULT
PMID: 34671929 (View on PubMed)

Sardeli 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.

Reference Type RESULT
PMID: 29596307 (View on PubMed)

Other Identifiers

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130811

Identifier Type: -

Identifier Source: org_study_id

273319

Identifier Type: REGISTRY

Identifier Source: secondary_id

21/EM/0230

Identifier Type: OTHER

Identifier Source: secondary_id

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