Impact of Bariatric Surgery on Cardiorespiratory Function

• Conditions: Physical Activity; Bariatric Surgery Candidate; Obesity

• Registration Number: NCT02175810
• Lead Sponsor: St George's, University of London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-05-11
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)	One to two weeks before surgery and six months after surgery

Secondary Outcome Measures

Name	Time	Method
Heart function	One to two weeks before surgery and six months after surgery	Echocardiography will be performed to assess heart function.
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
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.
Lung function	One to two weeks before surgery and six months after surgery	Lung function will be assessed by spirometry and body plethysmography
Inspiratory muscle strength	One to two weeks before surgery and six months after surgery	Maximal inspiratory pressure and sniff nasal pressure will be recorded.

Trial Locations

Locations (1)

St George's Healthcare NHS Trust; 🇬🇧 London, United Kingdom