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Northern Board Beet Breathlessness Trial

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ClinicalTrials.gov Identifier: NCT01610024
Recruitment Status : Unknown
Verified June 2013 by Dr. Wendy Anderson, Northern Health and Social Care Trust.
Recruitment status was:  Recruiting
First Posted : June 1, 2012
Last Update Posted : June 26, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Wendy Anderson, Northern Health and Social Care Trust

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.


Condition or disease Intervention/treatment Phase
Exercise Tolerance (Measured in Minutes) Dietary Supplement: Beetroot Juice Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Study Start Date : August 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Beetroot Dietary Supplement: Beetroot Juice
Give subjects 500ml beetroot juice in the 24 hour period prior to class begins. They will receive this during 3 of the 6 weeks



Primary Outcome Measures :
  1. Exercise Tolerance [ Time Frame: 6 weeks ]
    Measuring incremental change in exercise tolerance between weeks of beetroot consumption and weeks of no beetroot consumption



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610024


Contacts
Contact: Wendy Anderson, MBBCh 0044 2894424000 Wendy.Anderson@northerntrust.hscni.net

Locations
United Kingdom
Antrim Area Hospital Recruiting
Antrim, County Antrim, United Kingdom, BT41 2RL
Contact: Wendy Anderson, MBBCh    00442894424000    wendy.anderson@northerntrust.hscni.net   
Principal Investigator: Wendy Anderson, MBBCh         
Sponsors and Collaborators
Northern Health and Social Care Trust

Responsible Party: Dr. Wendy Anderson, Consultant Respiratory Physician, Northern Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01610024     History of Changes
Other Study ID Numbers: RDF001
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013