Post-hospitalisation Nutritional Support and Gait Speed in COPD

NCT ID: NCT02261350

Last Updated: 2015-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Food Fortification

Food Fortification

Group Type EXPERIMENTAL

Food fortification

Intervention Type DIETARY_SUPPLEMENT

Oral Nutritional Supplements

Oral Nutritional Supplements - Fortisip Compact

Group Type EXPERIMENTAL

Oral Nutritional Supplements

Intervention Type DIETARY_SUPPLEMENT

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Food fortification

Intervention Type DIETARY_SUPPLEMENT

Oral Nutritional Supplements

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fortisip Compact, Nutricia Clinical

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role collaborator

The Hillingdon Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Man, PhD FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Locations

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The Hillingdon Hospital NHS Foundation Trust

Uxbridge, Middlesex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2013LF004H

Identifier Type: -

Identifier Source: org_study_id

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