NCT02241473

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. 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. 2.Comparing the metabolic and energetics adaptations to CHT vs CNT.
  3. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

10 months

First QC Date

September 10, 2014

Last Update Submit

September 15, 2014

Conditions

Keywords

gaitphysical activityenergy costefficiency

Outcome Measures

Primary Outcomes (4)

  • Body composition and mass

    All subjects will undergo dual-energy X-ray absorptiometry (DEXA) and bio-impedance for measurements of body composition.

    Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)

  • Net energy cost of walking

    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).

    Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)

  • Mechanical external and internal work

    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).

    Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)

  • Efficiency

    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.

    Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)

Secondary Outcomes (1)

  • Blood samples (this measure is a composite)

    Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)

Study Arms (2)

CH training group

EXPERIMENTAL

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

CN training group

ACTIVE COMPARATOR

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

Interventions

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.

CH training groupCN training group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sport Sciences of the University of Lausanne

Lausanne, Canton of Vaud, 1015, Switzerland

RECRUITING

Related Publications (17)

  • Browning RC, Baker EA, Herron JA, Kram R. Effects of obesity and sex on the energetic cost and preferred speed of walking. J Appl Physiol (1985). 2006 Feb;100(2):390-8. doi: 10.1152/japplphysiol.00767.2005. Epub 2005 Oct 6.

    PMID: 16210434BACKGROUND
  • Faiss R, Leger B, Vesin JM, Fournier PE, Eggel Y, Deriaz O, Millet GP. Significant molecular and systemic adaptations after repeated sprint training in hypoxia. PLoS One. 2013;8(2):e56522. doi: 10.1371/journal.pone.0056522. Epub 2013 Feb 20.

    PMID: 23437154BACKGROUND
  • Haufe S, Wiesner S, Engeli S, Luft FC, Jordan J. Influences of normobaric hypoxia training on metabolic risk markers in human subjects. Med Sci Sports Exerc. 2008 Nov;40(11):1939-44. doi: 10.1249/MSS.0b013e31817f1988.

    PMID: 18845972BACKGROUND
  • Hill JO, Peters JC. Environmental contributions to the obesity epidemic. Science. 1998 May 29;280(5368):1371-4. doi: 10.1126/science.280.5368.1371.

    PMID: 9603719BACKGROUND
  • Kayser B, Verges S. Hypoxia, energy balance and obesity: from pathophysiological mechanisms to new treatment strategies. Obes Rev. 2013 Jul;14(7):579-92. doi: 10.1111/obr.12034. Epub 2013 Mar 28.

    PMID: 23551535BACKGROUND
  • Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139.

    PMID: 15986358BACKGROUND
  • Messier SP, Legault C, Loeser RF, Van Arsdale SJ, Davis C, Ettinger WH, DeVita P. Does high weight loss in older adults with knee osteoarthritis affect bone-on-bone joint loads and muscle forces during walking? Osteoarthritis Cartilage. 2011 Mar;19(3):272-80. doi: 10.1016/j.joca.2010.11.010. Epub 2010 Dec 4.

    PMID: 21134477BACKGROUND
  • Millet GP, Faiss R, Brocherie F, Girard O. Hypoxic training and team sports: a challenge to traditional methods? Br J Sports Med. 2013 Dec;47 Suppl 1(Suppl 1):i6-7. doi: 10.1136/bjsports-2013-092793. No abstract available.

    PMID: 24282210BACKGROUND
  • Millet GP, Roels B, Schmitt L, Woorons X, Richalet JP. Combining hypoxic methods for peak performance. Sports Med. 2010 Jan 1;40(1):1-25. doi: 10.2165/11317920-000000000-00000.

    PMID: 20020784BACKGROUND
  • Netzer NC, Chytra R, Kupper T. Low intense physical exercise in normobaric hypoxia leads to more weight loss in obese people than low intense physical exercise in normobaric sham hypoxia. Sleep Breath. 2008 May;12(2):129-34. doi: 10.1007/s11325-007-0149-3.

    PMID: 18057976BACKGROUND
  • Peyrot N, Morin JB, Thivel D, Isacco L, Taillardat M, Belli A, Duche P. Mechanical work and metabolic cost of walking after weight loss in obese adolescents. Med Sci Sports Exerc. 2010 Oct;42(10):1914-22. doi: 10.1249/MSS.0b013e3181da8d1e.

    PMID: 20216466BACKGROUND
  • Peyrot N, Thivel D, Isacco L, Morin JB, Duche P, Belli A. Do mechanical gait parameters explain the higher metabolic cost of walking in obese adolescents? J Appl Physiol (1985). 2009 Jun;106(6):1763-70. doi: 10.1152/japplphysiol.91240.2008. Epub 2009 Feb 26.

    PMID: 19246657BACKGROUND
  • 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.

    BACKGROUND
  • Pollock ML, Miller HS Jr, Janeway R, Linnerud AC, Robertson B, Valentino R. Effects of walking on body composition and cardiovascular function of middle-aged man. J Appl Physiol. 1971 Jan;30(1):126-30. doi: 10.1152/jappl.1971.30.1.126. No abstract available.

    PMID: 5538779BACKGROUND
  • Rosenbaum M, Vandenborne K, Goldsmith R, Simoneau JA, Heymsfield S, Joanisse DR, Hirsch J, Murphy E, Matthews D, Segal KR, Leibel RL. Effects of experimental weight perturbation on skeletal muscle work efficiency in human subjects. Am J Physiol Regul Integr Comp Physiol. 2003 Jul;285(1):R183-92. doi: 10.1152/ajpregu.00474.2002. Epub 2003 Feb 27.

    PMID: 12609816BACKGROUND
  • Wiesner S, Haufe S, Engeli S, Mutschler H, Haas U, Luft FC, Jordan J. Influences of normobaric hypoxia training on physical fitness and metabolic risk markers in overweight to obese subjects. Obesity (Silver Spring). 2010 Jan;18(1):116-20. doi: 10.1038/oby.2009.193. Epub 2009 Jun 18.

    PMID: 19543214BACKGROUND
  • Fernandez Menendez A, Saudan G, Sperisen L, Hans D, Saubade M, Millet GP, Malatesta D. Effects of Short-Term Normobaric Hypoxic Walking Training on Energetics and Mechanics of Gait in Adults with Obesity. Obesity (Silver Spring). 2018 May;26(5):819-827. doi: 10.1002/oby.22131. Epub 2018 Mar 25.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Davide Malatesta, Dr

    Institute of Sport Sciences of the University of Lausanne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Malatesta, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr (Ph.D., Senior Lecturer)

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations