Influence of Muscle Strength on the Energy Cost of Walking in Obese Subjects
OBELIX
2 other identifiers
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Feb 2013
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 15, 2013
CompletedFirst Posted
Study publicly available on registry
February 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 25, 2014
July 1, 2014
10 months
February 15, 2013
July 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Energy cost of walking, expressed in Joules per kilogram per meter (J/kg/m).
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 Outcomes (8)
Muscle strength
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
Walking intensity
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
- +3 more secondary outcomes
Study Arms (2)
40 of an endurance training
ACTIVE COMPARATOREndurance training at 50% of VO2 peak measured by indirect calorimetry. Dietary Supplement: supplementation in fruits and vegetables.
30 minutes of a high intensity training
EXPERIMENTALThis 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.
Interventions
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: * 30 sec at 120% of Vo2max, * 1 min at 50% of Vo2max, * 15 sec at 30-40 revolutions per minute of strength training at 100% of the maximal anaerobic power, which will be first determined by means of a force-velocity test on a Monark ergometer, * 1 min at 50% of Vo2max. 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.
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.
Eligibility Criteria
You may qualify if:
- Men and women
- years old
- ≤ BMI ≤40 kg / m²
- sedentary
- considered clinically stable
- able to rehabilitation training
- having signed an informed consent
- without professional activity
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de La Réunion
Saint-Pierre, La Réunion, 97448, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephane Schneebeli, PI
CHU de La Réunion
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2013
First Posted
February 18, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 25, 2014
Record last verified: 2014-07