Northern Board Beet Breathlessness Trial
1 other identifier
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 1, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJune 26, 2013
June 1, 2013
1.2 years
May 30, 2012
June 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Exercise Tolerance
Measuring incremental change in exercise tolerance between weeks of beetroot consumption and weeks of no beetroot consumption
6 weeks
Study Arms (1)
Beetroot
ACTIVE COMPARATORInterventions
Give subjects 500ml beetroot juice in the 24 hour period prior to class begins. They will receive this during 3 of the 6 weeks
Eligibility Criteria
You may qualify if:
- Already planned to attend the pulmonary rehabilitation class
You may not qualify if:
- Angina Prescribed regular nitrates, a resting heart rate \>100bpm, a resting blood pressure \<110 systolic, postural hypotension, prescribed PDE5 inhibitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antrim Area Hospital
Antrim, County Antrim, BT41 2RL, United Kingdom
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Respiratory Physician
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 1, 2012
Study Start
August 1, 2012
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
June 26, 2013
Record last verified: 2013-06