NCT01794377

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

February 15, 2013

Last Update Submit

July 24, 2014

Conditions

Keywords

Obesity

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 COMPARATOR

Endurance training at 50% of VO2 peak measured by indirect calorimetry. Dietary Supplement: supplementation in fruits and vegetables.

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.

Behavioral: 30 minutes of high intensity training

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.

30 minutes of a high intensity training

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.

40 of an endurance training

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephane Schneebeli, PI

    CHU de La Réunion

    PRINCIPAL INVESTIGATOR

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

Locations