Impact of Bariatric Surgery on Cardiorespiratory Function

Sponsor
St George's, University of London (Other)
Overall Status
Unknown status
CT.gov ID
NCT02175810
Collaborator
Universidade Federal do Triangulo Mineiro (Other), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)
24
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52
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Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    24 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study
    Study Start Date :
    Jun 1, 2014
    Anticipated Primary Completion Date :
    Oct 1, 2018
    Anticipated Study Completion Date :
    Oct 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Cardiorespiratory function assessed by peak oxygen consumption (VO2peak) [One to two weeks before surgery and six months after surgery]

    Secondary Outcome Measures

    1. Lung function [One to two weeks before surgery and six months after surgery]

      Lung function will be assessed by spirometry and body plethysmography

    2. Heart function [One to two weeks before surgery and six months after surgery]

      Echocardiography will be performed to assess heart function.

    3. Inspiratory muscle strength [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 St George's Healthcare NHS Trust London United Kingdom SW17 0RE

    Sponsors and Collaborators

    • St George's, University of London
    • Universidade Federal do Triangulo Mineiro
    • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St George's, University of London
    ClinicalTrials.gov Identifier:
    NCT02175810
    Other Study ID Numbers:
    • 13.0217
    First Posted:
    Jun 26, 2014
    Last Update Posted:
    May 11, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by St George's, University of London
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2018