Effects of Chronic Acid-Base Changes on Ventilatory and Perceptual Responses
| Tracking Information | |||||
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| First Received Date ICMJE | July 23, 2009 | ||||
| Last Updated Date | December 14, 2012 | ||||
| Start Date ICMJE | November 2009 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Breathlessness intensity (10-point Borg scale) [ Time Frame: Measured at the end of each 3 day treatment period ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Breathlessness intensity (10-point Borg scale) [ Time Frame: Baseline and measured at the end of each 5 day treatment period ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00946933 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Exercise capacity (peak VO2) [ Time Frame: Measured at the end of each 3 day treatment period ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Exercise capacity (peak VO2) [ Time Frame: Baseline and measured at the end of each 5 day treatment period ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Chronic Acid-Base Changes on Ventilatory and Perceptual Responses | ||||
| Official Title ICMJE | Effects of Chronic Acid-Base Changes on the Ventilatory and Perceptual Response to Hypercapnia, Hypoxia and Exercise in Healthy Older Adults | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00946933 | ||||
| Other Study ID Numbers ICMJE | DSS-16198 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Denis O'Donnell, Queen's University | ||||
| Study Sponsor ICMJE | Queen's University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Queen's University | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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