The Effect of Exercise in Patients Awaiting Bariatric Surgery

NCT05235945 | Recruiting DMC

• 3 other identifiers: 13081127331921/EM/0230
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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), 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.

Conditions

Bariatric Surgery Candidate; Obesity

Keywords

exercise; fitness; pre-operative; prehabilitation; bariatric; obesity; surgery

Outcome Measures

Primary Outcomes (1)

• Fitness (VO2 in ml/kg/min)

  VO2 (at anaerobic threshold (AT) and peak exercise) using gas-analysed cardiopulmonary exercise testing.

  4 weeks

Secondary Outcomes (7)

• Resting metabolic rate (VO2 in ml/kg/min)

  4 weeks

• Maximal grip strength (kg)

  4 weeks

• Body mass (kg)

  4 weeks

• Autonomic control (heart-rate variability)

  4 weeks

• Participant satisfaction feedback

  4 weeks

Study Arms (2)

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.

Behavioral: Online exercise intervention

Control

NO INTERVENTION

Usual care

Interventions

Online exercise intervention BEHAVIORAL

Described in arm descriptions

Online exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, wC1E6BT, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 34671929 RESULT

• 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.

  PMID: 29596307 RESULT

• Durey 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.

  PMID: 41232096 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Belinda Durey

  UCL, UniSA and UNSW

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Martin

CONTACT

+44 1752 600600; daniel.martin@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 11, 2022
• Study Start: June 16, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)