Status:
COMPLETED
Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet on the Evolution of Body Fat
Lead Sponsor:
Centre Hospitalier Universitaire de la Réunion
Conditions:
Obesity
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy of 3 of physical exercise training programs, with a supplementation in fruits and vegetables, on body composition. 126 women will be randomized in...
Detailed Description
Background: in Reunion Island, in 2000 the REDIA study showed a prevalence of type 2 diabetes among 30-69 years old people above 17%, a prevalence of obesity among women of 20% and 10% for men. Accord...
Eligibility Criteria
Inclusion
- women
- 20-40 years old
- 27 ≤ BMI ≤40 kg / m²
- sedentary
- considered clinically stable
- able to rehabilitation training
- having signed an informed consent
- without professional activity
Exclusion
- blood glucose ≥ 1.26 g / l
- HbA1c ≥ 6.5%
- severe hypertension (SBP ≥ 180 mmHg and / or DBP ≥ 110 mmHg)
- hypertension (≥140/90 mmHg) untreated or treated by beta blocker or calcium blocker
- absolute and relative contraindication to the maximal exercise test (ACC / AHA 2002) and / or physical training
- inability to achieve the maximum exercise test and / or the metabolic exercise test by indirect calorimeter
- uncompensated cardiovascular and / or respiratory disease revealed by exercise test
- pacemaker or defibrillator
- recent cardiovascular events (heart failure, treated by positive inotropic drugs, angioplasty within the last 10 days, cardiac surgery within the last 3 months, valvular disease requiring surgical correction, evolving myopericarditis, severe ventricular arrhythmias non stabilized under treatment)
- known and documented myopathy
- cancer
- acute and chronic inflammatory disease
- end stage renal disease
- digestive system operation
- treated by corticoids, thyroid hormone, antidepressant or neuroleptics
- pregnancy
- mental deficiency that prevents the understanding of informed consent and protocol
- participation to another research protocol
- attendance in the previous month to a program of rehabilitation training or a diet
- associated evolutionary disease causing significant impairment of general condition.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01464073
Start Date
November 1 2011
End Date
September 1 2012
Last Update
July 29 2015
Active Locations (1)
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1
Centre Hospitalier Universitaire
Saint-Pierre, Île de La Réunion, France, 97448