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 Locations

  • United Kingdom
    • County Antrim
      • Antrim, County Antrim, United Kingdom, BT41 2RL

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
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

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.

Sponsor

Northern Health and Social Care Trust

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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