Is Resistance Exercise More Effective Than Endurance in Reducing Obesity Relapse in Post-bariatric Surgery Patients (BariOptimize)

Searching for the Optimal Exercise Training Regimen for Reducing Obesity Relapse in Post Bariatric Surgery Patients With Insufficient Weight Loss - BariOPTIMIZE Randomized Parallel-arm Clinical Trial

The goal of this clinical trial is to compare the effects of resistance exercise and endurance in post-bariatric surgery patients with insuficcient weight loss. The main question it aims to answer is:

• Is resistance exercise more effective than endurance exercise in preventing obesity relapse in post-bariatric surgery patients with insuficcient weight loss?
• Is resistance exercise more effective than endurance exercise in increasing resting metabolic rate in post-bariatric surgery patients with insuficcient weight loss?

Participants will be randomly assigned to one of the following groups:

• Resistance group: performing resistance exercise-training for 16 weeks
• Endurace group: performing endurance exercise-training for 16 weeks
• Control group: no intervention / standard medical care

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Patients
• Intervention / Treatment: Other: Exercise

Detailed Description

As lean body mass losses following bariatric surgery (BS) negatively affect resting metabolic rate (RMR), metabolic regulation and physical function, the researchers hypothesize that resistance exercise (REx) could more effectively prevent obesity relapse following BS. Also, the increased mechanical loading on lumbar spine intervertebral discs is associated with an ampered spinal health and low pressure pain threshold sensitvity in these patients. The main purpose of this project is to determine which exercise mode is best suited to prevent obesity and increase RMR of post-BS patients with insufficient weight loss.

To accomplish this, the researchers will perform a single center 3-parallel-arm open-label randomized clinical trial to determine if resistance exercise is superior to endurance exercise in reducing obesity relapse in post-BS patients with insufficient weight loss.

Aditionally we aim to investigate if resistance exercise is more effective than endurance exercise in producing changes in pressure pain threshold, spine mobility and thoracolumbar strength in post-BS patients with insufficient weight loss.

Patients will be enrolled in 4 (possibly 5) consecutive cohorts of n=20. These must be between 18 and 65 years old and have performed bariatric surgery in the prior 18 to 24 months. Participants will be randomly assigned one of three groups: control (CON), resistance exercise (REx) and endurance exercise (EEx), while the latter two will be enrolling exercise-training programs. All the groups will be assessed in two moments: baseline and 16 weeks (end of exercise programme). Both the training sessions and the assessments will be performed at Porto Faculty of Sports (FADEUP).

The study is expected to run for 2.5 years while including 5 cohorts of patients.

Participants will be the chance to participate for free in exercise sessions (REx, EEx ) and to have free access to the results of health evaluations performed. Main risks for participants in the study will be the potential adverse events associated with exercise or physical evaluations and the burden of time spent in exercise sessions and evaluations.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélder R Fonseca, PhD; Email: hfonseca@fade.up.pt
• Study Contact Backup: Name: Tiago L Montanha, MSc; Phone Number: +351 22 04 25 200; Email: lmontanha@fade.up.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-450
    • Recruiting
    • FADEUP
    • Contact: Hélder R Fonseca, PhD; Email: hfonseca@fade.up.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18 and 65 years (until the end of intervention)
• Having performed primary bariatric surgery (gastric sleeve or RYGB methods) in the prior 18 to 24 months in S. João Hospital center.
• Willing to participate and commit to intervention

Exclusion Criteria:

• Already taking part in a structured exercise programme.
• Presenting health condition contraindicating exercise practice
• Inability to commit with intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Does not enrole in exercise-training programme.
Experimental: Resistance group; 16 weeks of resistance exercise-training.	Other: Exercise; Resistance and endurance supervised exercise-training. The training programme will last for 16 weeks. Training sessions will be held at Porto Faculty of Sports, 3 times per week with the duration of 1 hour.
Experimental: Endurance group; 16 weeks of endurance exercise-training.	Other: Exercise; Resistance and endurance supervised exercise-training. The training programme will last for 16 weeks. Training sessions will be held at Porto Faculty of Sports, 3 times per week with the duration of 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent fat mass	Change in fat mass percentage measured by DXA at 0 and 16 weeks (pre and post intervention)	16 weeks
Resting metabolic rate	Change in resting metabolic rate measured by indirect calorimetry at 0 and 16 weeks (pre and post intervention)	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold lumbar paraspinal	Change in Pressure Pain Threshold at 0 and 16 weeks (pre and post intervention)	16 weeks
Lean body mass	Change in lean body mass measured by DXA at 0 and 16 weeks (pre and post intervention)	16 weeks
Spine mobility, posture and stability	Change in spine mobility, posture and stability measured by algometer and Spinal Mouse and at 0 and 16 weeks (pre and post intervention)	16 weeks
Trunk muscle strength	Change in trunk muscle strength measured by dynamometry and expressed as peak torque relative to body weight at 0 and 16 weeks (pre and post intervention)	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lean body mass	Change in lean body mass at 0, 16 and 32 weeks (pre and post intervention and post follow-up)	32 weeks

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Fundação para a Ciência e a Tecnologia; Research Centre in Physical Activity, Health and Leisure, Portugal

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bariatric surgery; Resistance exercise; Resting metabolic rate
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Recurrence
• Other Study ID Numbers: CIAFEL2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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