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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02843048 |
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Date of registration:
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14/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bariatric Surgery and Exercise Bone Trial
BaSEIB |
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Scientific title:
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BaSEIB Clinical Trial - Bariatric Surgery and Exercise Intervention Bone Trial |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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86 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02843048 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Hélder Fonseca, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CIAFEL |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metabolic Bone Disease
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Obesity
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Accidental Falls
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Intervention(s)
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Behavioral: Standard medical care
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Behavioral: Exercise training program
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Primary Outcome(s)
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Bone Material Strength index (BMSi)
[Time Frame: 12 months]
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Bone mineral density
[Time Frame: 12 months]
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Biochemical marker of bone resorption
[Time Frame: 12 months]
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Secondary ID(s)
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PTDC/DTP-DES/0968/2014
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POCI-01-0145-FEDER-016707
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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