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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
University of Limerick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxia focused on measuring Hypoxic conditioning, Cardio pulmonary exercise testing

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 2, 2015
    Last Updated
    April 29, 2021
    Sponsor
    University of Limerick
    Collaborators
    University of Oxford
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    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

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    Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity

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