NCT00603122

Brief Summary

The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

Status
completed

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

March 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

January 15, 2008

Last Update Submit

May 18, 2014

Conditions

Keywords

altitude illnesshypoxia

Outcome Measures

Primary Outcomes (1)

  • acute mountain sickness

    during ascent

Secondary Outcomes (1)

  • mountaineering success, oxygen saturation, breathing pattern

    during ascent

Study Arms (2)

1

EXPERIMENTAL

fast ascent

Behavioral: ascent protocol

2

ACTIVE COMPARATOR

slow ascent

Behavioral: ascent protocol

Interventions

ascent protocolBEHAVIORAL

ascent protocol for the two groups has different acclimatization time

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, physically fit subject
  • Mountaineering experience

You may not qualify if:

  • Any type of cardiac or respiratory disease
  • Regular intake of any medication
  • History of high altitude pulmonary oedema
  • Severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Bloch KE, Latshang TD, Turk AJ, Hess T, Hefti U, Merz TM, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Schoch OD. Nocturnal periodic breathing during acclimatization at very high altitude at Mount Muztagh Ata (7,546 m). Am J Respir Crit Care Med. 2010 Aug 15;182(4):562-8. doi: 10.1164/rccm.200911-1694OC. Epub 2010 May 4.

    PMID: 20442435BACKGROUND
  • Garde A, Giraldo BF, Jane R, Latshang TD, Turk AJ, Hess T, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Hefti U, Merz TM, Schoch OD, Bloch KE. Periodic breathing during ascent to extreme altitude quantified by spectral analysis of the respiratory volume signal. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:707-10. doi: 10.1109/EMBC.2012.6346029.

    PMID: 23365990BACKGROUND
  • Latshang TD, Turk AJ, Hess T, Schoch OD, Bosch MM, Barthelmes D, Merz TM, Hefti U, Hefti JP, Maggiorini M, Bloch KE. Acclimatization improves submaximal exercise economy at 5533 m. Scand J Med Sci Sports. 2013 Aug;23(4):458-67. doi: 10.1111/j.1600-0838.2011.01403.x. Epub 2011 Nov 3.

    PMID: 22093058BACKGROUND
  • Bloch KE, Turk AJ, Maggiorini M, Hess T, Merz T, Bosch MM, Barthelmes D, Hefti U, Pichler J, Senn O, Schoch OD. Effect of ascent protocol on acute mountain sickness and success at Muztagh Ata, 7546 m. High Alt Med Biol. 2009 Spring;10(1):25-32. doi: 10.1089/ham.2008.1043.

MeSH Terms

Conditions

Altitude SicknessHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Konrad E Bloch, MD

    Pulmonary Division, University Hospital of Zurich, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

March 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

May 20, 2014

Record last verified: 2014-05