Training in Hypoxia to Prevent Acute Mountain Sickness

Prevention of Acute Mountain Sickness (AMS) by Intermittent Hypoxic Training

Some studies suggest that high-altitude related illnesses - like acute mountain sickness - could be prevented by acclimatisation, reached at low altitude using training in simulated altitude. The purpose of this study is to determine whether training in hypoxia is suitable to prevent acute mountain sickness.

Study Overview

• Status: Unknown
• Conditions: Healthy; Acute Mountain Sickness
• Intervention / Treatment: Other: hypoxia; Other: normoxia

Detailed Description

In a three week-period, healthy probands undergo 3 times a week a bicycle ergometer training in simulated altitude followed by 1 week passive exposure at simulated low altitude. 5 days after last exposure, a field study starts performing a rapid ascent to the Capanna Regina Margherita (4559m). Acute mountain sickness is assessed by established scoring systems.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Schommer, MD; Phone Number: +496221568256; Email: kai.schommer@med.uni-heidelberg.de
• Study Contact Backup: Name: Peter Baertsch, MD; Phone Number: +496221568101; Email: peter_baertsch@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Departement of Sports Medicine, University of Heidelberg
    • Contact: Kai Schommer, MD; Phone Number: +49 (0)6221 568256; Email: kai.schommer@med.uni-heidelberg.de
    • Contact: Peter Bärtsch, MD; Phone Number: +49 (0)6221 268101; Email: peter.baertsch@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy
• non-smoker
• endurance training min. 2x/week

Exclusion Criteria:

• any diseases
• previous exposure to altitudes higher than 2000m (last 6 weeks)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hypoxia; training in simulated altitude	Other: hypoxia; training in simulated altitude in a hypoxic chamber (normobaric hypoxia)
Placebo Comparator: Normoxia; training under normoxic conditions	Other: normoxia; training under normoxic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of acute mountain sickness	after 20 hours at 4559m

Secondary Outcome Measures

Outcome Measure	Time Frame
Severity of acute mountain sickness	after 20 hours at 4559m

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Kai Schommer, MD, Departement of Sports Medicine, University of Heidelberg

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: April 21, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 25, 2010
• Last Update Submitted That Met QC Criteria: June 24, 2010
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: mountain sickness
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: S-160/2008