Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity
Primary Purpose
Hypoxia
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypoxia
Normoxia
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia focused on measuring Hypoxic conditioning, Cardio pulmonary exercise testing
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female individuals aged 50-70 years with sedentary lifestyles.
Exclusion Criteria:
- Known intolerance to altitude identified by the participant's clinical examination, history and pre-altitude screening completed by the research clinician.
- Non-availability and/or suitability to complete the required residential period within the altitude centre.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Hypoxia
Normoxia
Arm Description
Mild hypoxia of 15% oxygen, equivalent altitude of 2440m over a period of 7 days
Exposure to normal, sea-level air
Outcomes
Primary Outcome Measures
Change in Cardio pulmonary functional variables
Assess cardio pulmonary functional variables using cardio pulmonary exercise testing (CPET) prior and following participants completing each arm of the study
Secondary Outcome Measures
Full Information
NCT ID
NCT02523716
First Posted
June 2, 2015
Last Updated
April 29, 2021
Sponsor
University of Limerick
Collaborators
University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT02523716
Brief Title
Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity
Official Title
Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Failure to maintain access to Altitude Facility
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
December 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Limerick
Collaborators
University of Oxford
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary functional capacity.
Detailed Description
Background There is an urgent need to reduce morbidity and mortality following major surgery. Bodily demands for oxygen increase after major surgery, and postoperative outcomes can be predicted by quantifying the body's ability to meet increased mitochondrial demand for oxygen using cardiopulmonary exercise testing (CPET).
Design This is a preliminary, physiological study to establish the baseline relationship between mild hypoxia exposure and cardiopulmonary function. This study will begin to examine the feasibility and potential for achieving risk modification through low-oxygen (hypoxic) conditioning, in which a safe and convenient "dose" of mild hypoxia is used to improve CPET derived variables that predict mortality following surgery.
The study will use a randomised, double blind, sham-controlled, crossover design. After a baseline CPET test, participants will be exposed to 7 days of either mildly hypoxic or normoxic air. A follow up CPET test will then be used to determine if cardiopulmonary functional capacity increased after exposure. After a two week washout period, participants will return for a second 7-day session where the alternate exposure will be given. A final follow-up CPET test will then be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
Hypoxic conditioning, Cardio pulmonary exercise testing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypoxia
Arm Type
Experimental
Arm Description
Mild hypoxia of 15% oxygen, equivalent altitude of 2440m over a period of 7 days
Arm Title
Normoxia
Arm Type
Sham Comparator
Arm Description
Exposure to normal, sea-level air
Intervention Type
Other
Intervention Name(s)
Hypoxia
Intervention Description
Participants live within an altitude residence facility. Hypoxic acclimatisation will be achieved by venting the rooms with air containing a reduced oxygen content. The degree of hypoxia is ramped over a 2-day period as participants experience 14 hours of overnight hypoxic exposure (simulating altitude of : 1830m on Day 1; 2130m on Day 2). The final 5 days will be spent entirely in the altitude residence facility at a consistent hypoxia level (simulating approximately 2440m).
Intervention Type
Other
Intervention Name(s)
Normoxia
Intervention Description
Participants will live in the altitude residence facility. As a sham-control, normal sea level air will be circulated throughout the house.
Primary Outcome Measure Information:
Title
Change in Cardio pulmonary functional variables
Description
Assess cardio pulmonary functional variables using cardio pulmonary exercise testing (CPET) prior and following participants completing each arm of the study
Time Frame
Change in Cardio pulmonary functional variables between day 0 and day 7 in each arm of the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and female individuals aged 50-70 years with sedentary lifestyles.
Exclusion Criteria:
Known intolerance to altitude identified by the participant's clinical examination, history and pre-altitude screening completed by the research clinician.
Non-availability and/or suitability to complete the required residential period within the altitude centre.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Smith (Chief Investigator), MBBS, DPhil, FRCA, FAsMA
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phillip Jakeman, BSc, MSc, PhD
Organizational Affiliation
University of Limerick
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity
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