- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01610024
Northern Board Beet Breathlessness Trial
June 25, 2013 updated by: Dr. Wendy Anderson, Northern Health and Social Care Trust
Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung disease.
Using the already established pulmonary rehabilitation model, we aim to split the group of 8 into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on alternate (differing) weeks to see if it improves their overall exercise tolerance.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wendy Anderson, MBBCh
- Phone Number: 0044 2894424000
- Email: Wendy.Anderson@northerntrust.hscni.net
Study Locations
-
-
County Antrim
-
Antrim, County Antrim, United Kingdom, BT41 2RL
- Recruiting
- Antrim Area Hospital
-
Contact:
- Wendy Anderson, MBBCh
- Phone Number: 00442894424000
- Email: wendy.anderson@northerntrust.hscni.net
-
Principal Investigator:
- Wendy Anderson, MBBCh
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Already planned to attend the pulmonary rehabilitation class
Exclusion Criteria:
- Angina Prescribed regular nitrates, a resting heart rate >100bpm, a resting blood pressure <110 systolic, postural hypotension, prescribed PDE5 inhibitors.
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
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Beetroot
|
Give subjects 500ml beetroot juice in the 24 hour period prior to class begins.
They will receive this during 3 of the 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Tolerance
Time Frame: 6 weeks
|
Measuring incremental change in exercise tolerance between weeks of beetroot consumption and weeks of no beetroot consumption
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
August 1, 2012
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
November 1, 2013
Study Registration Dates
First Submitted
May 30, 2012
First Submitted That Met QC Criteria
May 30, 2012
First Posted (Estimate)
June 1, 2012
Study Record Updates
Last Update Posted (Estimate)
June 26, 2013
Last Update Submitted That Met QC Criteria
June 25, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- RDF001
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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