Impact of Bariatric Surgery on Cardiorespiratory Function

NCT02175810 | Unknown

• 1 other identifier: 13.0217
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Bariatric Surgery Candidate; Physical Activity

Keywords

Obesity; Bariatric surgery; physical activity; cardiopulmonary exercise test

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)

  One to two weeks before surgery and six months after surgery

Secondary Outcomes (5)

• Lung function

  One to two weeks before surgery and six months after surgery

• Heart function

  One to two weeks before surgery and six months after surgery

• Inspiratory muscle strength

  One to two weeks before surgery and six months after surgery

• Peripheral muscle strength

  One to two weeks before surgery and six months after surgery

• Free living sedentary and physical activity times

  One to two weeks before surgery and six months after surgery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

St George's Healthcare NHS Trust

London, SW17 0RE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marcia S Volpe

  Universidade Federal Triangulo Mineiro

  PRINCIPAL INVESTIGATOR

• Dimitra Nikoletou

  Kingston University and St George's University of London

  STUDY CHAIR

• Marcus Reddy

  St George's Healthcare NHS Trust

  STUDY DIRECTOR

Central Study Contacts

Dimitra Nikoletou, PhD

CONTACT

+44 20 8725 5647; dinikole@sgul.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

GB (1)