- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00946933
Effects of Chronic Acid-Base Changes on Ventilatory and Perceptual Responses
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 2V7
- Respiratory Investigation Unit at Kingston General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Denis E O'Donnell, MD, FRCPC, Queen's University and Kingston General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DSS-16198
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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