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

NCT ID: NCT00946933

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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acid-base balance ventilatory control dyspnea exercise modified rebreathing procedure Normal older

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

0.025 g/kg/day of NaCl (sodium chloride)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

0.025 g/kg/day of NaCl (sodium chloride)

High salt diet

0.2 g/kg/day of NH4Cl (ammonium chloride)

Group Type ACTIVE_COMPARATOR

NH4Cl (ammonium chloride)

Intervention Type DIETARY_SUPPLEMENT

0.2 g/kg/day of NH4Cl (ammonium chloride)

Interventions

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NH4Cl (ammonium chloride)

0.2 g/kg/day of NH4Cl (ammonium chloride)

Intervention Type DIETARY_SUPPLEMENT

placebo

0.025 g/kg/day of NaCl (sodium chloride)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Denis O'Donnell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denis E O'Donnell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Locations

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Respiratory Investigation Unit at Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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DSS-16198

Identifier Type: -

Identifier Source: org_study_id