Northern Board Beet Breathlessness Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Northern Health and Social Care Trust
Sponsor:
Information provided by (Responsible Party):
Dr. Wendy Anderson, Northern Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT01610024
First received: May 30, 2012
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Exercise Tolerance (Measured in Minutes)
Dietary Supplement: Beetroot Juice
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)

Resource links provided by NLM:


Further study details as provided by Northern Health and Social Care Trust:

Primary Outcome Measures:
  • Exercise Tolerance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measuring incremental change in exercise tolerance between weeks of beetroot consumption and weeks of no beetroot consumption


Estimated Enrollment: 8
Study Start Date: August 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 30, 2012
Last Updated: June 25, 2013
Health Authority: United Kingdom: National Health Service

ClinicalTrials.gov processed this record on August 20, 2014