- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794377
Influence of Muscle Strength on the Energy Cost of Walking in Obese Subjects (OBELIX)
Study Overview
Status
Conditions
Intervention / Treatment
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:
Regular physical activity associated with a hypocaloric diet and an intake of fruits and vegetables can reduce body fat mass and prevent the inflammatory and oxidative stress which are associated with obesity. Daily physical activities such as carrying bags, making housework, stair climbing, or simply walking, are recommended to increase total daily energy expenditure. However, obese individuals have a higher energy cost of walking compared with their lean counterparts. This higher energy cost of walking does not induce higher total daily energy expenditure by an increase in activity energy expenditure, but inversely, increases exercise intensity and reduces walking practice. It has been shown that this higher energy cost of walking could be due to reduced lower extremity muscle strength of obese individuals. Moreover, muscle strength is also reduced after a weight loss due to a decrease in lean body mass. However, it has been shown in lean and over-weight individuals, that strength training could induce a decrease of the energy cost of walking, making easier walking activities.
Thus, we propose in obese patients to compare the short- and medium-term results of two training protocols for 5 months, both associated with a diet supplemented with fruits and vegetables, on reducing energy cost of walking. The study will last 9 months in total with a 5 months training period.
Participants will be randomized into 2 arms: arm 1 will consist of an interval strength training for 30 min on bicycle ergometer (which include strengthening exercises in an high intensity interval training), and arm 2 will consist of a isocaloric continuous exercise realised at moderate intensity (50 % of Vo2max) for 40 min on bicycle ergometer too. Participants will meet for training three times per week for 5 months under supervision of an exercise physiologist. All the participants will have an initial nutritional education session at the beginning of the study and will answer to questionnaires on training experience during the 5 months training period (Exercise difficulties, pain...).
At the beginning of the study and at each follow-up visit (5th and 9th month), all participants will have:
- biological analysis : blood glucose, HbA1c, insulin, cholesterol total, HDL, LDL, triglycerides, C reactive protein (CRP), albumin, creatinine, urinary parameters, antioxidant status, inflammatory markers,
- maximal cardiopulmonary exercise,
- anthropometric and functional examinations : weight, height, waist, hip and thigh circumferences, blood pressure and body composition assessed by dual x-ray absorptiometry,
- laboratory tests : measurements of energy cost of walking, walking pattern on treadmill, and muscle strength,
- questionnaires on quality of life, alimentary behaviour, experience of physical activities and on physical activities compliance and motivation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
La Réunion
-
Saint Pierre, La Réunion, France, 97448
- CHU de la Réunion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 40 of an endurance training
Endurance training at 50% of VO2 peak measured by indirect calorimetry.
Dietary Supplement: supplementation in fruits and vegetables.
|
The moderate-intensity continuous exercise group will carry out a 40-min session of continuous cycling at a moderate intensity (50 % of Vo2max). Training three times per week for 5 months under supervision of an exercise physiologist. Initial nutritional education session at the beginning of the study Questionnaires on training experience during the 5 months training period (Exercise difficulties, pain...). Dietary Supplement: supplementation in fruits and vegetables (5 per day) during all the study. |
Experimental: 30 minutes of a high intensity training
This arm consist of an interval strength training for 30 min on bicycle ergometer (which include strengthening exercises in an high intensity interval training). Dietary Supplement: supplementation in fruits and vegetables. |
This group will carry out a 5-min warm-up period on bicycle ergometer at an intensity corresponding to 50% of Vo2max before performed eight times the intermittent training exercise as follows:
The training session will be terminated by a 3-min cool-down period at 40% of Vo2max. Training three times per week for 5 months under supervision of an exercise physiologist. Initial nutritional education session at the beginning of the study Questionnaires on training experience during the 5 months training period (Exercise difficulties, pain...). Dietary Supplement: supplementation in fruits and vegetables (5 per day) during all the study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
|
improvement of muscle strength
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Biomechanism of walking
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
|
Improvement of the Biomechanism of walking
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Walking intensity
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
|
Improvement of the decrease in walking intensity (% VO2max)
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Body composition
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
|
Improvement of the body composition (decrease in fat mass, in waist, hip and thigh circumferences and increase in lean mass)
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Change in biological parameters
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
|
Improve the change of markers of inflammation Tumor Necrosis Factor [TNF] alpha, interleukin 6 [IL-6], Leptin and adiponectin and antioxidant status test Folin-Ciocalteu and test DiPhényl-Pycril-Hydrazil [DPPH], blood glucose, HbA1c, insulinemia
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Alimentary behaviour
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
|
Improvement of alimentary behaviour
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Quality of life
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
|
Improvement of quality of life with Medical Outcome Survey Short-Form 36
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Physical activities compliance and motivation
Time Frame: At the inclusion (M0), and at M5 and at the end of the study at M9
|
Improvement of physical activities compliance and motivation with questionaire about:
|
At the inclusion (M0), and at M5 and at the end of the study at M9
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephane Schneebeli, PI, CHU de la Réunion
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBELIX
- 2012/CHU/01 (Other Identifier: CHU de La Réunion)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on 40 of an endurance training
-
University of GiessenHannover Medical SchoolUnknownType 2 DiabetesGermany
-
Schön Klinik Berchtesgadener LandCompletedChronic Obstructive Pulmonary DiseaseGermany
-
General Committee of Teaching Hospitals and Institutes...Cairo University; Taibah UniversityCompleted
-
University Hospital HeidelbergDietmar Hopp Stiftung; Friederike Rosenberger (University Hospital Heidelberg)...Completed
-
Molde University CollegeCompleted
-
University of ViennaCompletedCOVID-19 | Post-COVID-19 Syndrome | Long COVID-19Austria
-
Landsteiner InstitutLund University; Medical University of Vienna; Mein Hanusch-Krankenhaus; Fondazione... and other collaboratorsCompletedType 2 Diabetes Mellitus | Insulin ResistanceAustria
-
Universität des SaarlandesThe German Heart FoundationCompletedChronic Heart Failure | Dilated CardiomyopathyGermany
-
Hospital Clinic of BarcelonaActive, not recruitingPulmonary Arterial HypertensionSpain
-
Charite University, Berlin, GermanyUnknownHeart Failure | Sudden Cardiac Death | Cardiac Resynchronisation TherapyGermany