Effects of Chronic Acid-Base Changes on Ventilatory and Perceptual Responses

December 14, 2012 updated by: Dr. Denis O'Donnell, Queen's University

Effects of Chronic Acid-Base Changes on the Ventilatory and Perceptual Response to Hypercapnia, Hypoxia and Exercise in Healthy Older Adults

Approximately 30% of people aged 65 years and older experience breathlessness (perceived respiratory difficulty) during daily activity. The main causes of increased breathlessness in the healthy elderly are poorly understood and are the main focus of the proposed study. Some possible contributing factors include abnormalities in the control and/or mechanics of breathing. To evaluate these possible contributory factors, the investigators will compare ventilatory and perceptual responses to: 1) exercise, 2) increased levels of inspired carbon dioxide, and 3) reduced levels of inspired oxygen under strictly-controlled experimental conditions where the investigators increase or decrease breathing requirements by altering dietary salt intake in healthy 40-80 year old men and women.

Exercise and rebreathing tests will be performed at baseline and at the end of each 3 day treatment period. Breathlessness intensity will be measured and compared at a standardized work rate, ventilation or end-tidal PCO2 during these tests.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Respiratory Investigation Unit at Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy, regularly active adults
  • non-smoking
  • BMI 18-30 kg/m2

Exclusion Criteria:

  • history of lung and/or heart disease (including cardiac arrhythmias) or other comorbidity which could interfere with proper conduct of the intervention or tests
  • hypotension or hypertension
  • hypercholesterolemia
  • sleep disordered breathing
  • inability to perform cycle exercise or comply with other testing procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
0.025 g/kg/day of NaCl (sodium chloride)
0.025 g/kg/day of NaCl (sodium chloride)
Active Comparator: High salt diet
0.2 g/kg/day of NH4Cl (ammonium chloride)
0.2 g/kg/day of NH4Cl (ammonium chloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breathlessness intensity (10-point Borg scale)
Time Frame: Measured at the end of each 3 day treatment period
Measured at the end of each 3 day treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise capacity (peak VO2)
Time Frame: Measured at the end of each 3 day treatment period
Measured at the end of each 3 day treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Denis E O'Donnell, MD, FRCPC, Queen's University and Kingston General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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