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NCT02261350 Clinical Trial

Post-hospitalisation Nutritional Support and Gait Speed in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02261350
Other study ID # 2013LF004H
Secondary ID
Status Terminated
Phase Phase 3
First received May 8, 2014
Last updated October 30, 2015
Start date January 2014
Est. completion date September 2015

Study information
Verified date October 2015
Source Royal Brompton & Harefield NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 22
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Food fortification

• Oral Nutritional Supplements

Locations
Country Name City State
United Kingdom The Hillingdon Hospital NHS Foundation Trust Uxbridge Middlesex

Sponsors (3)
Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust Medical Research Council, The Hillingdon Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in four-metre gait speed (m/s) following nutritional support Change from baseline to 12 weeks No
Secondary Change in weight (kg) following nutritional support Change from baseline to 12 weeks No
Secondary Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support Change from baseline to 12 weeks No
Secondary Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support Change from baseline to 12 weeks No
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