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

NCT02523716 | Terminated

• 1 other identifier: 2014_02_33
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoxia

Keywords

Hypoxic conditioning; Cardio pulmonary exercise testing

Outcome Measures

Primary Outcomes (1)

• 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

  Change in Cardio pulmonary functional variables between day 0 and day 7 in each arm of the study.

Study Arms (2)

Hypoxia

EXPERIMENTAL

Mild hypoxia of 15% oxygen, equivalent altitude of 2440m over a period of 7 days

Other: Hypoxia

Normoxia

SHAM COMPARATOR

Exposure to normal, sea-level air

Other: Normoxia

Interventions

Hypoxia OTHER

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).

Hypoxia

Normoxia OTHER

Participants will live in the altitude residence facility. As a sham-control, normal sea level air will be circulated throughout the house.

Normoxia

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female individuals aged 50-70 years with sedentary lifestyles.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Limerick: lead
• University of Oxford: collaborator

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Smith (Chief Investigator), MBBS, DPhil, FRCA, FAsMA

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Phillip Jakeman, BSc, MSc, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: August 14, 2015
• Study Start: May 1, 2015
• Primary Completion: September 30, 2015
• Study Completion: December 30, 2015
• Last Updated: December 6, 2023

Record last verified: 2021-04