Post-hospitalisation Nutritional Support and Gait Speed in COPD

October 30, 2015 updated by: Royal Brompton & Harefield NHS Foundation Trust

The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD

To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

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
    • Middlesex
      • Uxbridge, Middlesex, United Kingdom, UB8 3NN
        • The Hillingdon Hospital NHS Foundation Trust

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to consent
  • Patients at moderate or severe risk of malnutrition
  • Adults over the age of 40
  • Hospitalised with an AECOPD

Exclusion Criteria:

  • Receiving long term parental or enteral nutrition
  • Inability to swallow or difficulty liquids
  • Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance
  • Co-existing active cancer, progressive neurological condition or active GI disorder.
  • Receiving palliative care with expectation of death within 3 months
  • Cognitive dysfunction or unable to consent

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Food Fortification
Dietary supplement: Food fortification
Experimental: Oral Nutritional Supplements
Oral Nutritional Supplements - Fortisip Compact
Dietary supplement: Oral Nutritional Supplements
Other Names:
  • Fortisip Compact, Nutricia Clinical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in four-metre gait speed (m/s) following nutritional support
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in weight (kg) following nutritional support
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks
Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks
Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Medical Research Council
The Hillingdon Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: William Man, PhD FRCP, Royal Brompton & Harefield NHS Foundation 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

January 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013LF004H

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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