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Impact of Bariatric Surgery on Cardiorespiratory Function

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ClinicalTrials.gov Identifier: NCT02175810
Recruitment Status : Unknown
Verified May 2018 by St George's, University of London.
Recruitment status was:  Recruiting
First Posted : June 26, 2014
Last Update Posted : May 11, 2018
Sponsor:
Collaborators:
Universidade Federal do Triangulo Mineiro
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
St George's, University of London

Study Description
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Brief Summary:

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.


Condition or disease
Obesity Bariatric Surgery Candidate Physical Activity

Study Design
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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study
Study Start Date : June 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Cardiorespiratory function assessed by peak oxygen consumption (VO2peak) [ Time Frame: One to two weeks before surgery and six months after surgery ]

Secondary Outcome Measures :
  1. 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

  2. Heart function [ Time Frame: One to two weeks before surgery and six months after surgery ]
    Echocardiography will be performed to assess heart function.

  3. 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.

  4. 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

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with scheduled bariatric surgery at St George's Healthcare NHS Trust.
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175810


Contacts
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Contact: Dimitra Nikoletou, PhD +44 20 8725 5647 dinikole@sgul.ac.uk

Locations
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United Kingdom
St George's Healthcare NHS Trust Recruiting
London, United Kingdom, SW17 0RE
Contact: Dimitra Nikoletou    +44 20 8725 5647    dinikole@sgul.ac.uk   
Sub-Investigator: Emma R McGlone         
Sub-Investigator: Ommar A Khan         
Sponsors and Collaborators
St George's, University of London
Universidade Federal do Triangulo Mineiro
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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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
More Information
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02175810    
Other Study ID Numbers: 13.0217
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Keywords provided by St George's, University of London:
Obesity
Bariatric surgery
physical activity
cardiopulmonary exercise test
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight