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Bariatric Surgery and Exercise Bone Trial (BaSEIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Centro Hospitalar De São João, E.P.E.
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Hélder Fonseca, Universidade do Porto

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Metabolic Bone Disease Accidental Falls Behavioral: Exercise training program Behavioral: Standard medical care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: 12 months ]
    Assayed by dual energy x-ray absorptiometry (DXA); g/cm2

  2. Biochemical marker of bone resorption [ Time Frame: 12 months ]
    Collagen type 1 cross-linked C-telopeptide (CTX; ng/mL)

  3. Bone Material Strength index (BMSi) [ Time Frame: 12 months ]
    Normalized parameter of bone material's resistance to indentation (OsteoProbe RUO)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • meet the referral criteria for bariatric surgery;
  • BMI >40 kg.m-2 or >35 kg.m-2 with obesity-related comorbidities;
  • Motivation to participate in the study, regardless to the allocation group

Exclusion Criteria:

  • use of drugs that interfere with bone metabolism (i.e. bisphosphonates, teriparatide, calcitonin, hormone replacement therapy, chronic use of corticosteroids, thiazide diuretics);
  • Unable to perform exercise of moderate intensity;
  • Health condition that could be aggravated by exercise (i.e. uncontrolled arterial hypertension, severe kidney disease, class III New York Heart Association heart failure);
  • Peri-menopausal status with last menstruation <1 year;
  • Known metabolic bone disease (i.e. Osteogenesis Imperfecta, Paget bone disease);
  • Concurrent participation in a structured exercise program (>30 min in duration >1 day/week);
  • Pregnancy or breast-feeding

Information from the National Library of Medicine

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


Locations
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Portugal
Faculdade de Desporto
Porto, Portugal, 4200-450
Sponsors and Collaborators
Universidade do Porto
Centro Hospitalar De São João, E.P.E.
Fundação para a Ciência e a Tecnologia
Investigators
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Principal Investigator: Hélder Fonseca, PhD CIAFEL
Additional Information:
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Responsible Party: Hélder Fonseca, PhD, Universidade do Porto
ClinicalTrials.gov Identifier: NCT02843048    
Other Study ID Numbers: PTDC/DTP-DES/0968/2014
POCI-01-0145-FEDER-016707 ( Other Grant/Funding Number: FEDER/COMPETE )
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hélder Fonseca, Universidade do Porto:
Osteoporosis
Bariatric Surgery
Physical exercise
Obesity
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases