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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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8 August 2016 |
Main ID: |
NCT02196571 |
Date of registration:
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19/07/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Structured Aerobic and Resistance Exercise and Gestational Diabetes
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Scientific title:
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The Impact of Structured Aerobic and Resistance Exercise on the Course and Outcome of Gestational Diabetes Mellitus |
Date of first enrolment:
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July 2014 |
Target sample size:
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42 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02196571 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Iva Sklempe Kokic, PT, PgD Kin |
Address:
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Telephone:
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Email:
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Affiliation:
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Association for functional rehabilitation, recreation and applied kinesiology Impuls |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- established diagnosis of gestational diabetes,
- age between 20 and 40,
- otherwise healthy pregnancy
Exclusion Criteria:
- pharmacological treatment with oral hypoglicemics and/or insulin therapy introduced
prior to trial enrollment,
- existing comorbidities and
- contraindications for exercise
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Gestational Diabetes Mellitus
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Intervention(s)
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Other: Structured Exercise
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Primary Outcome(s)
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Number of pregnant women with complications during pregnancy, labour and delivery
[Time Frame: up to labour]
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Secondary Outcome(s)
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Number of macrosomic infants
[Time Frame: delivery]
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Weight gain in pregnancy
[Time Frame: After recruitment and during pregnancy (30, 33 and 36 weeks)]
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Secondary ID(s)
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Impuls001
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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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