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Post-hospitalisation Nutritional Support and Gait Speed in COPD

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02261350
First Posted: October 10, 2014
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical Research Council
The Hillingdon Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
  Purpose
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.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Lung Diseases, Obstructive Bronchitis, Chronic Pulmonary Emphysema Dietary Supplement: Food fortification Dietary Supplement: Oral Nutritional Supplements Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: January 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Food Fortification
Food Fortification
Dietary Supplement: Food fortification
Experimental: Oral Nutritional Supplements
Oral Nutritional Supplements - Fortisip Compact
Dietary Supplement: Oral Nutritional Supplements
Other Name: Fortisip Compact, Nutricia Clinical
No Intervention: Usual Care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261350


Locations
United Kingdom
The Hillingdon Hospital NHS Foundation Trust
Uxbridge, Middlesex, United Kingdom, UB8 3NN
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Medical Research Council
The Hillingdon Hospitals NHS Foundation Trust
Investigators
Principal Investigator: William Man, PhD FRCP Royal Brompton & Harefield NHS Foundation Trust
  More Information

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02261350     History of Changes
Other Study ID Numbers: 2013LF004H
First Submitted: May 8, 2014
First Posted: October 10, 2014
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Emphysema
Bronchitis
Respiratory Tract Diseases
Lung Diseases, Obstructive
Pulmonary Emphysema
Bronchitis, Chronic
Disease Attributes
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections