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Post-hospitalisation Nutritional Support and Gait Speed in COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Obstructive

Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Food fortification
Oral Nutritional Supplements
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hillingdon Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Food Fortification

Oral Nutritional Supplements

Usual Care

Arm Description

Food Fortification

Oral Nutritional Supplements - Fortisip Compact

Outcomes

Primary Outcome Measures

Change in four-metre gait speed (m/s) following nutritional support

Secondary Outcome Measures

Change in weight (kg) following nutritional support
Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support
Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support

Full Information

First Posted
May 8, 2014
Last Updated
October 30, 2015
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Medical Research Council, The Hillingdon Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02261350
Brief Title
Post-hospitalisation Nutritional Support and Gait Speed in COPD
Official Title
The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Medical Research Council, The Hillingdon Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Obstructive, Bronchitis, Chronic, Pulmonary Emphysema

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Food Fortification
Arm Type
Experimental
Arm Description
Food Fortification
Arm Title
Oral Nutritional Supplements
Arm Type
Experimental
Arm Description
Oral Nutritional Supplements - Fortisip Compact
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Food fortification
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Nutritional Supplements
Other Intervention Name(s)
Fortisip Compact, Nutricia Clinical
Primary Outcome Measure Information:
Title
Change in four-metre gait speed (m/s) following nutritional support
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in weight (kg) following nutritional support
Time Frame
Change from baseline to 12 weeks
Title
Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support
Time Frame
Change from baseline to 12 weeks
Title
Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Man, PhD FRCP
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hillingdon Hospital NHS Foundation Trust
City
Uxbridge
State/Province
Middlesex
ZIP/Postal Code
UB8 3NN
Country
United Kingdom

12. IPD Sharing Statement

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Post-hospitalisation Nutritional Support and Gait Speed in COPD

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