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

Primary Purpose

Bariatric Surgery Candidate, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Online exercise intervention
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bariatric Surgery Candidate focused on measuring exercise, fitness, pre-operative, prehabilitation, bariatric, obesity, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University College LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online exercise intervention

Control

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

Fitness (VO2 in ml/kg/min)
VO2 (at anaerobic threshold (AT) and peak exercise) using gas-analysed cardiopulmonary exercise testing.

Secondary Outcome Measures

Resting metabolic rate (VO2 in ml/kg/min)
Energy expenditure at rest, collected using respiratory gas-analysis via metabolic cart.
Maximal grip strength (kg)
Hand grip dynamometry, best of three repeat measures on each hand (left and right)
Body mass (kg)
Body mass in kilograms using body weight scales.
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
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.
Body composition (%FM, %FFM)
Percent fat mass and percent fat-free mass using bioelectric impedance analysis (BIA)
Physical activity patterns
7-day physical activity patterns (sedentary time, low, moderate and vigorous physical activity) measured using accelerometer data

Full Information

First Posted
January 12, 2022
Last Updated
June 27, 2023
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT05235945
Brief Title
The Effect of Exercise in Patients Awaiting Bariatric Surgery
Acronym
BariPrehab
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Obesity
Keywords
exercise, fitness, pre-operative, prehabilitation, bariatric, obesity, surgery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online exercise intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Online exercise intervention
Intervention Description
Described in arm descriptions
Primary Outcome Measure Information:
Title
Fitness (VO2 in ml/kg/min)
Description
VO2 (at anaerobic threshold (AT) and peak exercise) using gas-analysed cardiopulmonary exercise testing.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Resting metabolic rate (VO2 in ml/kg/min)
Description
Energy expenditure at rest, collected using respiratory gas-analysis via metabolic cart.
Time Frame
4 weeks
Title
Maximal grip strength (kg)
Description
Hand grip dynamometry, best of three repeat measures on each hand (left and right)
Time Frame
4 weeks
Title
Body mass (kg)
Description
Body mass in kilograms using body weight scales.
Time Frame
4 weeks, and 6-months post-operatively
Title
Autonomic control (heart-rate variability)
Description
Heart-rate variability measured via electrocardiogram (ECG), assessing the variability between heart beats at rest, resting heart-rate, and exercise heart-rate response
Time Frame
4 weeks
Title
Participant satisfaction feedback
Description
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.
Time Frame
4 weeks
Title
Body composition (%FM, %FFM)
Description
Percent fat mass and percent fat-free mass using bioelectric impedance analysis (BIA)
Time Frame
4 weeks
Title
Physical activity patterns
Description
7-day physical activity patterns (sedentary time, low, moderate and vigorous physical activity) measured using accelerometer data
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnant or lactating mothers. Weight over 180 kg (due to weight restrictions of equipment used). Current use of betablockade. Obstructive sleep apnoea requiring home ventilation assistance. Hypo/hyperthyroidism. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Martin
Phone
+44 1752 600600
Email
daniel.martin@plymouth.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belinda Durey
Organizational Affiliation
UCL and UniSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London
City
London
ZIP/Postal Code
wC1E6BT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pushpsen Joshi
Email
uclh.randd@nhs.net
First Name & Middle Initial & Last Name & Degree
Belinda Durey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Summary format only, Access to IPD will be reviewed on a case-by-case basis following requests.
Citations:
PubMed Identifier
34671929
Citation
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.
Results Reference
result
PubMed Identifier
29596307
Citation
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.
Results Reference
result

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The Effect of Exercise in Patients Awaiting Bariatric Surgery

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