The Effect of Exercise in Patients Awaiting Bariatric Surgery (BariPrehab)

June 27, 2023 updated by: University College, London

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 and weight after surgery.

A single-site randomised trial at UCLH, recruiting patients awaiting bariatric surgery for obesity at 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 follow each participant's journey through surgery and determine whether the exercise intervention led to differences between the weight of the two groups after surgery. The investigators will also interview participants about their participation in the study in regard to the planning of future studies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 and metabolic rate compared with usual care (no exercise programme) along with alterations in autonomic control and medium-term postoperative weight loss.

The investigators propose a randomised controlled trial that will recruit 70 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 seven 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 follow each participant's journey through surgery and determine whether the exercise intervention led to differences between the two groups after surgery in terms of weight loss. 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 approximately 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. Post-surgery, at 12 weeks and 24 weeks, participants will be invited to attend follow-up assessment where body weight will be measured. The post-operative testing visits will be aligned with scheduled hospital follow-up appointments. The total duration of participation will be approximately 32 weeks (six weeks preoperatively to six months (26 weeks) postoperatively).

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E6BT
        • Recruiting
        • University College London
        • Contact:
        • Principal Investigator:
          • Belinda Durey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. Obstructive sleep apnoea requiring home ventilation assistance.
  5. Hypo/hyperthyroidism.
  6. Concurrent participation in other clinical intervention trial.
  7. Clinically significant medical co-morbidities (e.g. uncontrolled hypertension, unstable cardiovascular disease) that could place at risk of an adverse response to exercise.
  8. History of atrial fibrillation, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Experimental: 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.
Behavioral: Online exercise intervention
Described in arm descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fitness (VO2 in ml/kg/min)
Time Frame: 4 weeks
VO2 (at anaerobic threshold (AT) and peak exercise) using gas-analysed cardiopulmonary exercise testing.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting metabolic rate (VO2 in ml/kg/min)
Time Frame: 4 weeks
Energy expenditure at rest, collected using respiratory gas-analysis via metabolic cart.
4 weeks
Maximal grip strength (kg)
Time Frame: 4 weeks
Hand grip dynamometry, best of three repeat measures on each hand (left and right)
4 weeks
Body mass (kg)
Time Frame: 4 weeks, and 6-months post-operatively
Body mass in kilograms using body weight scales.
4 weeks, and 6-months post-operatively
Autonomic control (heart-rate variability)
Time Frame: 4 weeks
Heart-rate variability measured via electrocardiogram (ECG), assessing the variability between heart beats at rest, resting heart-rate, and exercise heart-rate response
4 weeks
Body composition (%FM, %FFM)
Time Frame: 4 weeks
Percent fat mass and percent fat-free mass using bioelectric impedance analysis (BIA)
4 weeks
Physical activity patterns
Time Frame: 7 days
7-day physical activity patterns (sedentary time, low, moderate and vigorous physical activity) measured using accelerometer data
7 days
Participant satisfaction feedback
Time Frame: 4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Belinda Durey, UCL and UniSA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130811
  • 273319 (Registry Identifier: IRAS)
  • 21/EM/0230 (Other Identifier: HRA and Health and Care Research Wales (HCRW))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Summary format only, Access to IPD will be reviewed on a case-by-case basis following requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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