Influence of Muscle Strength on the Energy Cost of Walking in Obese Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 59
- Locations
- 2
- Primary Endpoint
- Energy cost of walking, expressed in Joules per kilogram per meter (J/kg/m).
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of 2 physical exercise training programs, with a supplementation in fruits and vegetables, on energy cost of walking. 60 subjects will be randomized into 2 groups. The first program will be consist of an interval strength training for 30 min on bicycle ergometer (which include strengthening exercises in an high intensity interval training). The second program will be conducted at a relatively low intensity of effort, corresponding to 50% of oxygen uptake (VO2) peak measured by indirect calorimetry. All subjects will receive a free supplement of 5 fruits and vegetables per day during all the intervention. The intervention will last 9 months in total : 5 month at the hospital fallow by 4 month at home.
Detailed Description
Background: in Reunion Island in 2000, the REDIA study showed a prevalence of obesity among women and men of 20% and 10%, respectively. Obesity is associated with several diseases, including diabetes mellitus, hypertension, dyslipidaemia and ischaemic heart diseases. Regular physical activity associated with a hypocaloric diet and an intake of fruits and vegetables can reduce body fat mass and obesity-associated complications. However there is no consensus on the physical training protocols for prevention and treatment of obesity. As a consequence, future studies are required to improve obesity management and decrease obesity-associated complications.
Main objective: to compare the effects of two programs of rehabilitation training associated with a diet supplemented with fruits and vegetables on reducing energy cost of walking in obese adults.
Secondary objectives: to compare the effects of two programs of rehabilitation training associated with a diet supplemented with fruits and vegetables on:
- the mechanical properties of the lower extremity muscles,
- the biomechanics of walking,
- the walking intensity,
- body composition,
- the quality of life, and physical activities compliance and motivation,
- the alimentary behaviour,
- and the oxidative stress and the inflammatory status.
Abstract:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women
- •18-40 years old
- •30 ≤ BMI ≤40 kg / m²
- •sedentary
- •considered clinically stable
- •able to rehabilitation training
- •having signed an informed consent
- •without professional activity
Exclusion Criteria
- •blood glucose ≥ 1.26 g / l
- •HbA1c ≥ 6.5%
- •severe hypertension (Systolic Blood Pressure (SBP) ≥ 180 mmHg and / or Diastolic Blood Pressure (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 / American Heart Association 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
- •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.
Outcomes
Primary Outcomes
Energy cost of walking, expressed in Joules per kilogram per meter (J/kg/m).
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
Measure of the energy cost reduction between M0, M5 and M9
Secondary Outcomes
- Walking intensity(At the inclusion (M0), and at M5 and at the end of the study at M9)
- Physical activities compliance and motivation(At the inclusion (M0), and at M5 and at the end of the study at M9)
- Muscle strength(At the inclusion (M0), and at M5 and at the end of the study at M9)
- Alimentary behaviour(At the inclusion (M0), and at M5 and at the end of the study at M9)
- Quality of life(At the inclusion (M0), and at M5 and at the end of the study at M9)
- Biomechanism of walking(At the inclusion (M0), and at M5 and at the end of the study at M9)
- Body composition(At the inclusion (M0), and at M5 and at the end of the study at M9)
- Change in biological parameters(At the inclusion (M0), and at M5 and at the end of the study at M9)