Prehabilitation in Bariatric Surgery
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2019
CompletedFirst Posted
Study publicly available on registry
August 6, 2019
CompletedStudy Start
First participant enrolled
August 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedAugust 6, 2019
August 1, 2019
1.4 years
June 14, 2019
August 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight change
Increase (or decrease) in weight between the start of the program and the time of surgery (measured on a calibrated scale, with Maximum increments of 0.1Kg, under the same conditions, without footwear and with light clothing)
4-6 months
Secondary Outcomes (24)
Body mass index
4-6 months
Body composition
4-6 months
Associated complications-Blood pressure
4-6 months
Associated complications-lipids
4-6 months
Associated complications-glucose metabolism
4-6 months
- +19 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALEducational program and cognitive-behavioral intervention. The patient receives training in nutrition and cognitive-behavioral therapy, with specific training aimed at increasing physical activity, functional capacity and conditioning of the respiratory musculature (prehabilitation by a physiotherapist)
Control
ACTIVE COMPARATOREducational program and cognitive-behavioral intervention. The patient receives training in nutrition and cognitive-behavioral therapy, as well as standard instructions to increase physical activity.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- People with obesity (type II-IV), on the waiting list for bariatric surgery in the Complejo Hospitalario Universitario Materno-infantil de Las Palmas
You may not qualify if:
- any factor that, in the opinion of the researchers, limits the ability to monitor the intervention (language barrier, ...).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Complejo Hospitalario Universitario Materno-infantil de Las Palmas
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana M Wägner, MD, PhD
Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- A person external to the monitoring and evaluation of the patients will generate a random sequence (by computer), to assign the participants to their corresponding treatment group. The intervention sequence will be transcribed to cards that will be introduced in an envelope each. The envelopes will be opaque, sealed and numbered consecutively. Each time a patient agrees to participate in the trial, he/she signs the informed consent and we verify that he/she meets the inclusion criteria, but not the exclusion criteria, the corresponding envelope will be opened in correlative order. Patients will be assigned to one of two group interventions, unaware of the components in each group. The assessment of most of the outcomes will be blinded, too.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
June 14, 2019
First Posted
August 6, 2019
Study Start
August 22, 2019
Primary Completion
December 31, 2020
Study Completion
March 31, 2021
Last Updated
August 6, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After publication of the results
- Access Criteria
- Reasonable plan, acknowledgement of original investigators
Anonymized data will be shared upon request