Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures

NCT01408329 | Completed Results

• 1 other identifier: FRI0016
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cyclic Variation in Altitude Conditioning (CVAC) is a new technique that uses a pod-like device to expose users to controlled fluctuations in air pressure. It is designed to promote quicker altitude acclimatization, thus promoting improvements in exercise capacity at altitude and, possibly, at sea level. However, over the past few years, anecdotal stories from users of the device suggest that the CVAC treatments might be causing changes beyond the expected endurance exercise performance benefits. Therefore, the purpose of the study is to obtain data on some of the previous anecdotal claims regarding the device (e.g. increases in strength, improved glucose tolerance, reduction of neuropathic pain and decreased joint swelling) as well as to obtain broad questionnaire data in order to identify more specific variables to investigate in future studies.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Plasma Glucose Concentration

  Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10-12 h fast the morning after a CVAC session (except for baseline).

Study Arms (2)

Control

SHAM COMPARATOR

Sham altitude changes - The CVAC device consists of a small pod-like chamber attached to a computer system that controls a strong pump that can draw air rapidly out of the chamber to increase the simulated altitude. The sham-treated group (SH) was exposed to regular, slowly-fluctuating pressures that reached a maximum altitude of 607 m for all 30 sessions. Sham sessions mimicked the noises and initial pressure-change sensations created in the active sessions, thus giving naıve subjects the impression that they were experiencing altitude treatment. All subjects were blind to their elevation throughout the intervention.

Device: CVAC Device (Cyclic Variations in Altitude Conditioning)

Hypoxic intervention

EXPERIMENTAL

Cyclic Hypobaric Hypoxia (CHH) subjects were given 40 min sessions inside the CVAC device per day (two 20 min sessions sequentially per day), 3 days a week for 10 weeks, for a total of 30 sessions or 20 hours. After familiarization sessions, pre-programmed sessions were administered, progressing from Tier 1 to 5. Subjects rotated through three pre-programmed sessions per Tier and each session varied the pattern and rate of hypoxic fluctuations, so that subjects would experience a constantly changing stimulus at each elevation. Five weeks were allotted to progress from Tier 1 (3048 m) to Tier 4 (5486 m). At Tier 5 (6096 m), there was an additional 5 weeks of exposure.

Device: CVAC Device (Cyclic Variations in Altitude Conditioning)

Interventions

CVAC Device (Cyclic Variations in Altitude Conditioning) DEVICE

A hypobaric hypoxia chamber

Control; Hypoxic intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy middle aged men at risk for metabolic syndrome

You may not qualify if:

• Uncontrolled hypertension,
• sensitive ears,
• anything that would preclude person from sustaining rapid pressure changes

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Small Sample size

Results Point of Contact

• Title: Anne L Friedlander
• Organization: Stanford University

afriedlanderCW@gmail.com

650-725-7531

Study Officials

• Anne Friedlander, PhD

  Veterans Affairs Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consulting Professor

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 3, 2011
• Study Start: January 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2010
• Last Updated: September 22, 2015
• Results First Posted: September 22, 2015

Record last verified: 2015-08