Post-hospitalisation Nutritional Support and Gait Speed in COPD

Phase 3TerminatedNCT02261350

Royal Brompton & Harefield NHS Foundation Trust22 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

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

Interventions

Food fortificationDIETARY_SUPPLEMENT

Oral Nutritional SupplementsDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

The Hillingdon Hospital NHS Foundation Trust

Uxbridge, Middlesex, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: Change from baseline to 12 weeks

Secondary Outcomes

Change in weight (kg) following nutritional support

Time frame: 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 in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support

Time frame: Change from baseline to 12 weeks

Data from ClinicalTrials.gov

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