Effect of High Altitude Exposure, Acclimatization and Re-exposure on Postural Control in Lowlanders
Primary Purpose
Effect of High Altitude
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
altitude exposure
Sponsored by
About this trial
This is an interventional prevention trial for Effect of High Altitude focused on measuring postural control, high altitude
Eligibility Criteria
Inclusion Criteria:
- born, raised and currently living <800m
- No overnight stay at altitudes >1500 m 4 weeks before the study
Exclusion Criteria:
- Previous altitude intolerance to altitude <3000 m
- Pregnancy
- Health impairment, which requires regular treatment
Sites / Locations
- University of Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Altitude exposure
Arm Description
Acute high altitude exposure followed by 8 day acclimatization and reexposure for 8 days after 6 days at low altitude
Outcomes
Primary Outcome Measures
Center of pressure path length measured by Wii-balance board
Changes in center of pressure path length during the 2 sojourns at 5050 m and compared to lowland.
Secondary Outcome Measures
Cerebral tissue oxygen saturation measured by near infrared spectroscopy
Changes in cerebral oxygen saturation during the 2 sojourns at 5050 m and compared to lowland.
Postural stability measured by sharpened Romberg-test and heel-to-toe walk
Changes in postural stability during the 2 sojourns at 5050 m and compared to lowland.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02730182
Brief Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Postural Control in Lowlanders
Official Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Postural Control in Lowlanders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 9, 2016 (Actual)
Primary Completion Date
May 4, 2016 (Actual)
Study Completion Date
May 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on postural control
Detailed Description
Baseline measurements including the assessment of the center of pressure during 30s, the cerebral oxygen saturation and a sharpened Romberg test will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the base camp of the Atacama Large Millimeter/Submillimeter Array (ALMA) telescope station located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 8 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants will return to the Santiago area (520 m) for a 6 day recovery period.
A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of High Altitude
Keywords
postural control, high altitude
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Altitude exposure
Arm Type
Experimental
Arm Description
Acute high altitude exposure followed by 8 day acclimatization and reexposure for 8 days after 6 days at low altitude
Intervention Type
Other
Intervention Name(s)
altitude exposure
Intervention Description
altitude exposure
Primary Outcome Measure Information:
Title
Center of pressure path length measured by Wii-balance board
Description
Changes in center of pressure path length during the 2 sojourns at 5050 m and compared to lowland.
Time Frame
Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
Secondary Outcome Measure Information:
Title
Cerebral tissue oxygen saturation measured by near infrared spectroscopy
Description
Changes in cerebral oxygen saturation during the 2 sojourns at 5050 m and compared to lowland.
Time Frame
Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
Title
Postural stability measured by sharpened Romberg-test and heel-to-toe walk
Description
Changes in postural stability during the 2 sojourns at 5050 m and compared to lowland.
Time Frame
Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
born, raised and currently living <800m
No overnight stay at altitudes >1500 m 4 weeks before the study
Exclusion Criteria:
Previous altitude intolerance to altitude <3000 m
Pregnancy
Health impairment, which requires regular treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University of Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Postural Control in Lowlanders
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