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Hypoxic Training in Obese Patients (HYPOBESE)

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ClinicalTrials.gov Identifier: NCT02241473
Recruitment Status : Unknown
Verified September 2014 by Davide MALATESTA, University of Lausanne.
Recruitment status was:  Recruiting
First Posted : September 16, 2014
Last Update Posted : September 16, 2014
Sponsor:
Collaborators:
CHUV - Centre des Maladies Osseuses - Département de l'Appareil Locomoteur (DAL)
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Davide MALATESTA, University of Lausanne

Brief Summary:

By analyzing energetic and biomechanical basis of walking, and the subsequent changes induced by hypoxic vs normoxic training in obese individuals, it may optimize the use of walking in hypoxia to gain perspective for exercise prescription to set up training programs that aim to induce negative energy balance and to deal with weight management. However to the investigators knowledge, the analysis of changes in mechanics, energetics and efficiency of walking after continuous hypoxic training (CHT) has not been performed yet.

The aims of the present study were:

  1. Comparing the changes in body composition between continuous hypoxic training (CHT) and similar training in normoxia; e.g. continuous normoxic training (CNT) in obese subjects.
  2. Comparing the metabolic and energetics adaptations to CHT vs CNT.
  3. Finally, comparing the associated body‐loss induced gait modification since walking intensity at spontaneous walking speed (Ss) is lower in CHT than in CNT.

Condition or disease Intervention/treatment Phase
Obesity Other: Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Changes in Body Composition, Metabolic and Mechanical Responses to Hypoxic Walking Training in Obese Patients
Study Start Date : September 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: CH training group
During 3 weeks (9 sessions; three sessions/wk), subject will performed 60 min walking at spontaneous walking speed in hypoxic (continuous hypoxic training, CHT; simulated altitude of 3000 m) condition in a single‐blind fashion.
Other: Training
During 3 weeks (9 sessions; three sessions/wk), subject will performed 60 min walking at spontaneous walking speed in normoxic (continuous normoxic training; CNT) or hypoxic (continuous hypoxic training, CHT; simulated altitude of 3000 m) condition in a single‐blind fashion. Both CNT and CHT sessions will be performed in an hypoxic chamber (ATS Altitude, Sydney, Australia) built in our laboratory at an altitude of 380 m (Lausanne, Switzerland). In order to blind subjects to altitude, the system will also run for normoxic training groups with a normoxic airflow into the chamber.

Active Comparator: CN training group
During 3 weeks (9 sessions; three sessions/wk), subject will performed 60 min walking at spontaneous walking speed in normoxic (continuous normoxic training; CNT) condition in a single‐blind fashion.
Other: Training
During 3 weeks (9 sessions; three sessions/wk), subject will performed 60 min walking at spontaneous walking speed in normoxic (continuous normoxic training; CNT) or hypoxic (continuous hypoxic training, CHT; simulated altitude of 3000 m) condition in a single‐blind fashion. Both CNT and CHT sessions will be performed in an hypoxic chamber (ATS Altitude, Sydney, Australia) built in our laboratory at an altitude of 380 m (Lausanne, Switzerland). In order to blind subjects to altitude, the system will also run for normoxic training groups with a normoxic airflow into the chamber.




Primary Outcome Measures :
  1. Body composition and mass [ Time Frame: Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion) ]
    All subjects will undergo dual-energy X-ray absorptiometry (DEXA) and bio‐impedance for measurements of body composition.

  2. Net energy cost of walking [ Time Frame: Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion) ]
    The subjects will be then asked to complete five 6 min level walking trials on the instrumented treadmill at five equally spaced speeds (0.55, 0.83, 1.11, 1.38 and 1.66 m/s), in randomized order. They will be allowed to establish their own preferred stride rate combination for each condition and will be given 5 min of rest between walking trials. During the walking trials, oxygen uptake (V˙O 2), carbon dioxide (CO2) output (V˙C O2) and ventilation (V˙ E) will be measured breath‐by‐breath (OxyconPro, Jaeger, Germany) and the volume and gases calibrations will be checked before each trial. Oxygen uptake values from the last 2 min will be averaged and normalized to body mass (V˙O 2, mlO2∙kg-1∙min-1). This value minus resting V'O2 was then divided by walking speed to obtain the net energy cost of walking (mlO2∙kg-1∙m-1).

  3. Mechanical external and internal work [ Time Frame: Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion) ]
    During steady metabolic state (i.e., the last 2 min of walking for each speed), the mechanical external (Wext) and internal (Wint) work changes of 20 consecutive walking steps will be determined with an instrumented treadmill (H‐P‐COSMOS Treadmill MCU2 EPROM 2.31), consisting of a treadmill mounted on four 3‐D force sensors, following the methods described in detail by Cavagna (Cavagna 1975) and Willems et al. (1995).

  4. Efficiency [ Time Frame: Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion) ]
    Total mechanical work and efficiency. The total mass‐specific muscular work per distance travelled (Wtot) will be calculated as the sum of Wext and Wint. The mechanical efficiency will be computed as the ratio between Wtot and net energy cost of walking.


Secondary Outcome Measures :
  1. Blood samples (this measure is a composite) [ Time Frame: Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion) ]
    The blood samples were drawn at rest before (session 1) and after (session 12) the training program during fasting to determine total cholesterol (TC), high‐density lipoprotein (HDL), low‐density lipoprotein (LDL) and triglycerides (TG), leptin, total adiponectin, resistin, retinol‐binding protein 4 (RBP4), plasma glucose and insulin concentrations (this measure is a composite).



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy and free of clinically significant orthopaedic, neurological, cardiovascular or respiratory conditions.
  • BMI > 30 kg/m^2.
  • Age > 18 yr.

Exclusion Criteria:

  • Age > 40 yr.
  • BMI < 35 kg/m^2.
  • Diabetes.
  • Neurological disorders, orthopaedic injury, history of falls and medications that provoke dizziness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241473


Contacts
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Contact: Davide Malatesta, Dr +41 21 692 36 17 ext +41 davide.malatesta@unil.ch

Locations
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Switzerland
Institute of Sport Sciences of the University of Lausanne Recruiting
Lausanne, Vaud, Switzerland, 1015
Contact: Davide Malatesta, Dr    021 692 36 17 ext +41    davide.malatesta@unil.ch   
Principal Investigator: Davide Malatesta, Dr         
Sponsors and Collaborators
University of Lausanne
CHUV - Centre des Maladies Osseuses - Département de l'Appareil Locomoteur (DAL)
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Davide Malatesta, Dr Institute of Sport Sciences of the University of Lausanne

Publications:
Plewa M, Cieślińska‐Świder J, and Bacik B. Effects of the Weight loss Treatment on Selected Kinematic Gait Parameters in Obese Women. Journal of Human Kinetics 18: 3-14, 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Davide MALATESTA, Dr (Ph.D., Senior Lecturer), University of Lausanne
ClinicalTrials.gov Identifier: NCT02241473     History of Changes
Other Study ID Numbers: 136/14
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

Keywords provided by Davide MALATESTA, University of Lausanne:
gait
physical activity
energy cost
efficiency