Impact of Bariatric Surgery on Cardiorespiratory Function

May 10, 2018 updated by: St George's, University of London

Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study

Obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the World Health Organisation. Obesity results from chronic imbalance between energy intake and energy expenditure. Although early prevention of obesity is preferable, surgical treatment is often required for severely obese people.

Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity.

The purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

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

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0RE
        • Recruiting
        • St George's Healthcare NHS Trust
        • Contact:
        • Sub-Investigator:
          • Emma R McGlone
        • Sub-Investigator:
          • Ommar A Khan

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 to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with scheduled bariatric surgery at St George's Healthcare NHS Trust.

Description

Inclusion Criteria:

  • Ages 18 years to 50 years
  • Patients enrolled in the bariatric surgery program of St George's Hospital with BMI > 40 kg/m2, or 35-40 kg/m2 in the presence of other obesity-related comorbidities such as hypertension or type- 2 diabetes

Exclusion Criteria:

  • Locomotor difficulties which would prevent participants from completing the cardiopulmonary exercise testing
  • Weight > 190 kg (due to weight restrictions of equipment used to transfer patients in the event of medical emergencies)
  • Cognitive impairment
  • Patients unable to follow instructions in English

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
Time Frame: One to two weeks before surgery and six months after surgery
One to two weeks before surgery and six months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: One to two weeks before surgery and six months after surgery
Lung function will be assessed by spirometry and body plethysmography
One to two weeks before surgery and six months after surgery
Heart function
Time Frame: One to two weeks before surgery and six months after surgery
Echocardiography will be performed to assess heart function.
One to two weeks before surgery and six months after surgery
Inspiratory muscle strength
Time Frame: One to two weeks before surgery and six months after surgery
Maximal inspiratory pressure and sniff nasal pressure will be recorded.
One to two weeks before surgery and six months after surgery
Peripheral muscle strength
Time Frame: One to two weeks before surgery and six months after surgery
Maximum isometric strength of hand/ forearm, quadriceps and hip flexors muscles will be evaluated
One to two weeks before surgery and six months after surgery
Free living sedentary and physical activity times
Time Frame: One to two weeks before surgery and six months after surgery
Daily physical activity habits will be assessed by an accelerometer and International Physical Activity Questionnaire: Long (IPAQ-Long). Participants will be required to wear the accelerometer for four consecutive days during the two study points.
One to two weeks before surgery and six months after surgery

Collaborators and Investigators

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

Sponsor

St George's, University of London

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Universidade Federal do Triangulo Mineiro

Investigators

  • Principal Investigator: Marcia S Volpe, Universidade Federal Triangulo Mineiro
  • Study Chair: Dimitra Nikoletou, Kingston University and St George's University of London
  • Study Director: Marcus Reddy, St George's Healthcare NHS Trust

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

June 1, 2014

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.0217

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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