Clinical trial NCT02175810: Impact of Bariatric Surgery on Cardiorespiratory Function
Official title: Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Bariatric Surgery Candidate
Physical Activity
Keywords: Obesity
Bariatric surgery
physical activity
cardiopulmonary exercise test
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Triangulo Mineiro
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2014-06-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with scheduled bariatric surgery at St George's Healthcare NHS Trust.

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.


Eligibility 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

Primary outcomes:
measure: Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
timeFrame: One to two weeks before surgery and six months after surgery
Secondary outcomes:
measure: Lung function
timeFrame: One to two weeks before surgery and six months after surgery
measure: Heart function
timeFrame: One to two weeks before surgery and six months after surgery
measure: Inspiratory muscle strength
timeFrame: One to two weeks before surgery and six months after surgery
measure: Peripheral muscle strength
timeFrame: One to two weeks before surgery and six months after surgery
measure: Free living sedentary and physical activity times
timeFrame: One to two weeks before surgery and six months after surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
Study officials:
affiliation: Universidade Federal Triangulo Mineiro
name: Marcia S Volpe
role: PRINCIPAL_INVESTIGATOR
affiliation: Kingston University and St George's University of London
name: Dimitra Nikoletou
role: STUDY_CHAIR
affiliation: St George's Healthcare NHS Trust
name: Marcus Reddy
role: STUDY_DIRECTOR
References: