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Prehabilitation in Bariatric Surgery

NCT04046367 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-08-06

No results posted yet for this study

Summary

Obesity is a major public health problem in our region and constitutes a priority of the Canary Islands Health Plan. Bariatric surgery is the most effective intervention in the treatment of obesity and its complications. However, people with obesity have high surgical risk and long-term outcomes are related to pre-surgical weight loss.

In patients currently on the bariatric surgery waiting list, a randomized controlled trial will be performed in which two group interventions will be compared. One of the interventions (standard), will consist of educational modules in food and exercise, combined with cognitive-behavioral therapy. In the other, a specific training (prehabilitation) will be added to encourage physical activity and the conditioning of inspiratory muscles.

The pre-surgical weight loss (principal outcome) will be compared between groups, as well as the evolution of the complications of obesity, the functional status of the patients, their physical activity, quality of life, immediate complications of surgery and days of admission.

Conditions

  • Obesity
  • Bariatric Surgery Candidate

Interventions

BEHAVIORAL

Prehabilitation

Prehabilitation: The intervention of a physiotherapist will be added to the components of the control group. Patients will receive practical instructions on aerobic and resistance physical activity, as well as training of their inspiratory muscles.

BEHAVIORAL

Control

Standard group intervention. Educational program and cognitive-behavioral intervention. The patient receives training in nutrition and cognitive-behavioral therapy, as well as standard instructions to increase physical activity.

Sponsors & Collaborators

  • Fundación MAPFRE Guanarteme

    collaborator UNKNOWN

  • Hospital Universitario Insular Gran Canaria

    lead OTHER

Principal Investigators

  • Ana M Wägner, MD, PhD · Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046367 on ClinicalTrials.gov