NCT05632718

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

November 20, 2022

Last Update Submit

December 27, 2023

Conditions

Bariatric Surgery Patients

Keywords

Bariatric surgeryResistance exerciseResting metabolic rate

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Pressure Pain Threshold lumbar paraspinal

    16 weeks

  • Lean body mass

    16 weeks

  • Spine mobility, posture and stability

    16 weeks

  • Trunk muscle strength

    16 weeks

Study Arms (3)

Resistance group

EXPERIMENTAL

16 weeks of resistance exercise-training.

Other: Exercise

Endurance group

EXPERIMENTAL

16 weeks of endurance exercise-training.

Other: Exercise

Control group

NO INTERVENTION

Does not enrole in exercise-training programme.

Interventions

ExerciseOTHER

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.

Endurance groupResistance group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FADEUP

Porto, 4200-450, Portugal

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Tiago L Montanha, MSc

CONTACT

+351 22 04 25 200lmontanha@fade.up.pt

Hélder R Fonseca, PhD

CONTACT

hfonseca@fade.up.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single center 3-parallel-arm open-label randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC Principal Investigator

Study Record Dates

First Submitted

November 20, 2022

First Posted

December 1, 2022

Study Start

December 15, 2022

Primary Completion

December 30, 2024

Study Completion

April 30, 2025

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)