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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01607177
Other study ID # Bariatric Prehabilitation
Secondary ID
Status Completed
Phase Phase 3
First received May 24, 2012
Last updated November 12, 2013
Start date August 2012
Est. completion date September 2013

Study information

Verified date November 2013
Source University of Auckland, New Zealand
Contact n/a
Is FDA regulated No
Health authority New Zealand: Ministry of Health
Study type Interventional

Clinical Trial Summary

Preoperative exercise has been shown to improve physiological and functional capacity in patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is also thought to increase the likelihood that they will exercise postoperatively. However, compliance to this advice is extremely low. Text-message interventions have been shown to improve compliance to other lifestyle interventions. The investigators will compare the rate of compliance to preoperative exercise prior to bariatric surgery in patients who receive a daily text message to those who do not. The investigators will also compare weight loss.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date September 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre

- Operation used primarily for the treatment of morbid obesity

Exclusion Criteria:

- Operation not performed at Manukau Surgery Centre

- Patient does not have a mobile phone which can receive text messages

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Daily text message reminders
Daily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet.

Locations

Country Name City State
New Zealand Manukau Surgery Centre Auckland Manukau City

Sponsors (2)

Lead Sponsor Collaborator
University of Auckland, New Zealand Health Research Council, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients partaking in the minimum recommended amount of weekly physical activity >450 METmins per week of physical activity as measured by the internationally and locally validated IPAQ questionnaire. 6 weeks post recruitment No
Secondary Postoperative Physical Activity Quantity of physical acitivty will be measured as METmins per week as measured by the IPAQ questionnaire 6 weeks postoperatively No
Secondary Functional capacity Measured using the 6 minute walk test Baseline and 6 weeks post recuitment (preoperatively) No
Secondary Length of Hospital Stay Total number of days spent in hospital following their operation As assessed at day of discharge No
Secondary Short term weight loss Postoperative weight loss as measured by percentage of excess weight loss Out to 6 months postoperatively No
Secondary Perioperative complications Prospectively recorded postoperative complications graded according the Clavien-Dindo classification system Out to 30 days postoperatively Yes
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