ObesityOBELIXNCT01794377
Influence of Muscle Strength on the Energy Cost of Walking in Obese Subjects
A study testing 30 minutes of high intensity training and 40 of an endurance training in people with Obesity, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity
- What is being tested?
- 30 minutes of high intensity training and 40 of an endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- 30 minutes of high intensity training, 40 of an endurance training
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 minutes of high intensity trainingBehavioural
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.
40 of an endurance trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 40 of an endurance training | Active comparator | Endurance training at 50% of VO2 peak measured by indirect calorimetry. Dietary Supplement: supplementation in fruits and vegetables. Receives: Behavioral: 40 of an endurance training |
| 30 minutes of a high intensity training | Experimental | 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. Receives: Behavioral: 30 minutes of high intensity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Secondary outcomes (8)
Muscle strength
improvement of muscle strength
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Biomechanism of walking
Improvement of the Biomechanism of walking
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Walking intensity
Improvement of the decrease in walking intensity (% VO2max)
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Body composition
Improvement of the body composition (decrease in fat mass, in waist, hip and thigh circumferences and increase in lean mass)
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Change in biological parameters
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
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Alimentary behaviour
Improvement of alimentary behaviour
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Quality of life
Improvement of quality of life with Medical Outcome Survey Short-Form 36
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Physical activities compliance and motivation
Improvement of physical activities compliance and motivation with questionaire about:
- the adherence (number of session of physical activity are completed)
- secondary effects of the physical exercise program (tiredness, joint pain
Measured: At the inclusion (M0), and at M5 and at the end of the study at M9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Universite de La Reunion
- Responsible party
- Sponsor
- Investigators
- Stephane Schneebeli, PI, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794377
- Sponsor's protocol ID
- OBELIX
- Other IDs
- 2012/CHU/01
- Acronym
- OBELIX
- Status last verified
- Jul 2014
- First submitted
- 15 Feb 2013
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Muscle Strength on the Energy Cost of Walking in Obese Subjects
- ClinicalTrials.gov ID
- NCT01794377
- Acronym / sponsor ID
- OBELIX / OBELIX
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Universite de La Reunion
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 of an endurance training | Active comparator | Behavioral: 40 of an endurance trainingEndurance training at 50% of VO2 peak measured by indirect calorimetry. Dietary Supplement: supplementation in fruits and vegetables. |
| 30 minutes of a high intensity training | Experimental | Behavioral: 30 minutes of high intensity trainingThis 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women
- 18-40 years old
- 30 ≤ BMI ≤40 kg / m²
- sedentary
- considered clinically stable
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 minutes of high intensity trainingThis 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. | Behavioural | 30 minutes of a high intensity training |
| 40 of an endurance trainingThe 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. | Behavioural | 40 of an endurance training |
Primary outcome
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
8 secondary outcomes
Muscle strength
Time frame: 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
Walking intensity
Time frame: 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
Change in biological parameters
Time frame: 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
Quality of life
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane Schneebeli, PI principal investigator
CHU de La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 minutes of high intensity training and 40 of an endurance training in people with Obesity, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.