NCT02021890CompletedNot Applicable
A Standard Ballroom and Latin Dance Program to Improve Fitness and Adherence to Physical Activity in Individuals With Type 2 Diabetes and Obesity
University of Bologna4 sites in 1 country100 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- 5% reduction in BMI or waist circumference
Study Overview
Brief Summary
to test the metabolic and clinical effects of a 6-month program of dancing in subjects with type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units. Self-selection of the leisure time activity program was allowed to increase adherence to the physical activity programs.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •type 2 diabetes in fairly good metabolic control (glycosylated hemoglobin (HbA1c) < 8.5%) and/or obesity (Body Mass Index (BMI) ≥ 30 kg/m2 or waist circumference >94 cm in males, >80 in females), with/without prediabetes or minor alterations of HbA1c.
Exclusion Criteria
- •previous cardiovascular events, muscle-skeletal problems reducing physical ability, any general condition limiting systematic adherence
Outcomes
Primary Outcomes
5% reduction in BMI or waist circumference
Time Frame: 6 months
improved physical fitness (physical activity exceeding 10 MET-hour/week
Time Frame: 6 months
Secondary Outcomes
- 0.3% reduction of HbA1c in the presence of diabetes(6 months)
- 10% increase in 6-min walk test(6 months)
Investigators
Giulio Marchesini R., M.D.
Professor of Dietetics
University of Bologna
Study Sites (4)
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