Bariatric Surgery and Exercise Bone Trial (BaSEIB)
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|ClinicalTrials.gov Identifier: NCT02843048|
Recruitment Status : Unknown
Verified October 2017 by Hélder Fonseca, Universidade do Porto.
Recruitment status was: Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : October 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Metabolic Bone Disease Accidental Falls||Behavioral: Exercise training program Behavioral: Standard medical care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||BaSEIB Clinical Trial - Bariatric Surgery and Exercise Intervention Bone Trial|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2019|
Experimental: Exercise training
Exercise training plus standard medical follow-up care
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.
Active Comparator: Standard medical care
Standard medical follow-up care only
Behavioral: Standard medical care
Standard follow-up medical care following bariatric surgery
- Bone mineral density [ Time Frame: 12 months ]Assayed by dual energy x-ray absorptiometry (DXA); g/cm2
- Biochemical marker of bone resorption [ Time Frame: 12 months ]Collagen type 1 cross-linked C-telopeptide (CTX; ng/mL)
- Bone Material Strength index (BMSi) [ Time Frame: 12 months ]Normalized parameter of bone material's resistance to indentation (OsteoProbe RUO)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843048
|Faculdade de Desporto|
|Porto, Portugal, 4200-450|
|Principal Investigator:||Hélder Fonseca, PhD||CIAFEL|