Bariatric Surgery and Exercise Bone Trial

Summary

Despite being effective in weight reduction in severely obese patients, bariatric surgery (BS) negatively influences bone metabolism and increases the risk of falls thereby potentially increasing the risk of fracture. The mechanisms of BS induced bone loss are unknown but may be related to calcium and vitamin D malabsorption, changes in the energy regulation metabolism and gastrointestinal hormonal physiology. Since the etiology of BS induced bone loss is largely unknown, treatment relies mostly on calcium and vitamin D supplementation, which provide little benefit.

Exercise is an effective strategy to prevent bone mass losses in several health conditions. However, no study so far has examined the effects of an exercise-training program in the prevention of BS induced bone loss. The investigators main goal is to investigate the effects on bone metabolism and fracture risk of an exercise-training program specifically tailored to improve bone health and balance of patients that underwent BS. The investigators will perform a randomized controlled trial on obese patients (n=80; BMI\>40 Kg.m-2) elected to BS. Patients will be randomly assigned into 2 groups i) a group receiving standard follow-up and medical care, or ii) a group that will undergo a 11 months' Exercise Training program designed to improve bone health and reduce fall risk plus the standard follow-up and medical care. All patients will be assessed i) before the surgery, ii) one month, iii) 6 months, and iv) 12 months after the surgery. Assessments include: biochemical markers of bone turnover (BTM), BMD, bone tissue biomechanical properties, hormones involved in the regulation of energy, gastrointestinal and bone metabolism, body composition, BMI, nutritional intake, balance, muscle strength, cardiorespiratory fitness and daily physical activity. These evaluations will allow the investigators to understand the effects of an exercise-training program on bone metabolism of BS patients, contributing also to further elucidate the mechanisms underlying BS induced bone loss and fracture risk increase. The investigators will use established methods in the literature as well as novel procedures, which will enable them to overcome some of the limitations of previous studies. At the end of the study the investigators expect to have collected consistent data about whether an exercise-training program is or is not able to effectively prevent BS induced bone losses and fracture risk increases.

Conditions

• Obesity
• Metabolic Bone Disease
• Accidental Falls

Interventions

BEHAVIORAL

Exercise training program

Participants allocated to the "Exercise training plus standard medical care" group will undergo an exercise-training program of 11 months duration, 3 sessions/week, and 60 minutes/session, starting one month after the surgery. Each exercise session will be supervised and will include 5 major components: i) warm-up, ii) multidirectional jumps, iii) balance, iv) strength and, v) cool down. This structure is planned to meet two main objectives: i) enhance bone formation and, ii) reduce fall risk by improving muscle strength, cardiorespiratory fitness and balance.

BEHAVIORAL

Standard medical care

Standard follow-up medical care following bariatric surgery

Sponsors & Collaborators

• Centro Hospitalar De São João, E.P.E.

  collaborator OTHER

• Fundação para a Ciência e a Tecnologia

  collaborator OTHER

• Universidade do Porto

  lead OTHER

Principal Investigators

• Hélder Fonseca, PhD · CIAFEL

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2018-03-31

Completion

2019-03-31

Countries

• Portugal

Study Locations