Prehabilitation in Bariatric Surgery

Prehabilitation in Bariatric Surgery: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Behavioral: Prehabilitation; Behavioral: Control

Detailed Description

Obesity is a major public health problem, responsible for an increased risk of hypertension, obesity, dyslipidemia, type 2 diabetes, cardiovascular disease, some types of cancer, psychiatric diseases and mortality.

Bariatric surgery has proven to be the most effective method for reducing weight and related comorbidities in patients with morbid obesity. However, pre-surgical weight loss reduces postsurgical complications. In addition, weight loss before surgery seems to be the only factor positively associated with post-surgical weight loss, and this effect seems to be more pronounced in patients with BMI> 45 kg / m2.

Pre-operative physical conditioning (prehabilitation) can improve the patient's functional capacity before major surgery. Most studies showing this have been conducted in orthopedic surgery and abdominal cancer surgery. There are very few studies that evaluate prehabilitation in patients undergoing bariatric surgery.

Objective

Comparison of a multidisciplinary group intervention with another one to which specific training focused on increasing physical activity is added, in patients on the surgical waiting list for bariatric surgery in a randomized controlled trial.

Methods

Design Randomized, controlled parallel group, clinical trial.

Intervention Duration: 4-month intervention, with biweekly 2,5-hour group sessions, followed by a monthly reinforcement session of 1h until surgery.

Intervention A: Educational program and cognitive-behavioral intervention (control group)

Intervention B: Educational program and cognitive-behavioral intervention, with specific training aimed at increasing physical activity, functional capacity and conditioning of the respiratory muscles (intervention group).

Study population The recruitment of the participants will be made from the waiting list of bariatric surgery (obesity II-IV), selecting patients with estimated waiting time above 4 months. Patients will be excluded if any reason for inadequate follow-up is identified, according to the investigators criteria.

Ethical aspects The design and execution of this study will be done in accordance with the Declaration of Helsinki and the homogenized European guidelines of good clinical practice. Before their participation, the patients will sign an informed consent form. The protocol has been approved by the local ethics committee

Sample size Based on the size of the waiting list for bariatric surgery, with a mean duration of 17 months, and that the intervention is considered feasible on two groups of 10 people, in parallel, in each branch, (a weekly session of 2h per nutrition nurse, with support from additional professional). Starting with a pilot group of each intervention and taking into account an overlap between them, in 18 months about 60-80 patients could be included in total.

With 80 patients included, without losses, and assuming a standard deviation of weight of 11Kg, and for a bilateral p <0.05 a difference between groups of 7 and 8Kg, with a statistical power of 80 and 90%, respectively. If we assume a standard deviation of 6Kg, as shown by other studies, the detectable difference would be reduced to about 4Kg.

Statistical analysis A descriptive analysis of the baseline situation will be made. The qualitative variables are expressed as a percentage, quantitative, as mean (SD) or median, according to if its distribution is normal or not, respectively. Comparisons will be made between treatment groups, using chi squared for qualitative variables and Student's t or Mann Whitney's U for quantitative variables. The analysis of results will be done by intention to treat analysis. That is, all patients who have baseline data and have been randomized, will be included, regardless of their subsequent attendance to the Program.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana M Wägner, MD,PhD; Phone Number: +34 928441617; Email: awagfah@gobiernodecanarias.org
• Study Contact Backup: Name: Yaiza García-Delgado, MD; Phone Number: +34 928441617; Email: ygarciadelgado@gmail.com

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35016
      • Complejo Hospitalario Universitario Materno-infantil de Las Palmas
      • Contact: Ana M Wägner, M.D.; Phone Number: +34 928453431; Email: ana.wagner@ulpgc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• People with obesity (type II-IV), on the waiting list for bariatric surgery in the Complejo Hospitalario Universitario Materno-infantil de Las Palmas

Exclusion Criteria:

• any factor that, in the opinion of the researchers, limits the ability to monitor the intervention (language barrier, ...).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Educational 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)	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.; Other Names: Inspiratory muscle training, physical activity.
Active Comparator: Control; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Calculated as weight (in Kg) divided by the squared height (in meters)	4-6 months
Body composition	Percentage of body fat and lean mass estimated by bioimpedance	4-6 months
Associated complications-Blood pressure	Systolic and diastolic blood pressure (in sitting position, after 5 minutes of rest, using a manual sphygmomanometer, with a cuff adapted to thebrachial circumference of the patient)	4-6 months
Associated complications-lipids	total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides (automatic methods) in mg/dl colorimetric tests)	4-6 months
Associated complications-glucose metabolism	HbA1c (HPLC standardized against DCCT-IFCC)	4-6 months
Associated complications-treatments	Number of drugs used for associated cardiovascular risk factors	4-6 months
Associated complications-liver enzymes	AST, ALT, GGT (automatic methods)	4-6 months
Adherence to the intervention	Attendance at the sessions (number of sessions attended) programmed.	4-6 months
Physical activity-steps	Registered by pedometers (number of steps/week)	4-6 months
Physical activity-self reported	International Physical Activity Program (IPAQ) questionnaire	4-6 months
Eating patterns-Adherence to Mediterranean diet	Validated Food questionnaire (simplified questionnaire of 14 questions of adherence to the diet Mediterranean diet of PREDIMED) . Higher scores indicate higher adherence	4-6 months
Eating patterns-eating disorders	Standardised questionnaire (bulimia and binge disorders of the EDI -Eating Disorder Inventory)	4-6 months
General health status	EQ-5D questionnaire (higher scores indicate better self-perceived health status)	4-6 months
Emotional state	Hospital scale of anxiety and depression (HADS)	4-6 months
Subjective evaluation of satisfaction, perceived effort and motivation	Development of a specific questionnaire with Likert type scale for the patient to score 1 to 10 each of the 3 items.	4-6 months
Functional capacity-walk test	6-minute walk test (TM6): meters completed during the test	4-6 months
Functional capacity- grip strength	Grip test: hand grip dynamometer and the grip strength in both hands, indicating the dominant one.	4-6 months
Functional capacity-respiratory muscle strength	Maximum inspiratory pressure (PIM) and expiratory pressure (PEM)	4-6 months
Functional capacity-plethysmography	Lung volumes, VR (residual volume) and CRF (functional residual capacity) in ml	4-6 months
Functional capacity-Spirometry	Forced spirometry: Forced expiratory volume in 1 second (FEV1), Functional Vital Capacity (FVC) in ml. Tiffenau index will be calculated. Mesoespiratory flows	4-6 months
Functional capacity-sleep apnea questionnaire	Stop-bang screening questionnaire for sleep-related breathing disorders.	4-6 months
Functional capacity-sleep apnea polygraph	Home cardiorespiratory polygraphy for diagnosis of disorder	4-6 months
Surgical complications	Early post-surgical complications (<30 days)	5-7 months after start of intervention
Surgery-length of admission	Post-surgical length of stay (stratified by surgical technique).	5-7 months after start of intervention

Collaborators and Investigators

• Sponsor: Hospital Universitario Insular Gran Canaria
• Collaborators: Fundación MAPFRE Guanarteme
• Investigators: Principal Investigator: Ana M Wägner, MD, PhD, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria

Study record dates

Study Major Dates

• Study Start (Anticipated): August 22, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; nutrition; prehabilitation
• Other Study ID Numbers: 2018-170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be shared upon request
• IPD Sharing Time Frame: After publication of the results
• IPD Sharing Access Criteria: Reasonable plan, acknowledgement of original investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No