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Clinical Trials/NCT02261350
NCT02261350TerminatedPhase 3

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

Royal Brompton & Harefield NHS Foundation Trust1 site in 1 country22 target enrollmentStarted: January 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
22
Locations
1
Primary Endpoint
Change in four-metre gait speed (m/s) following nutritional support
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Oral Nutritional Supplements

Experimental

Oral Nutritional Supplements - Fortisip Compact

Intervention: Oral Nutritional Supplements (Dietary Supplement)

Usual Care

No Intervention

Food Fortification

Experimental

Food Fortification

Intervention: Food fortification (Dietary Supplement)

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(Change from baseline to 12 weeks)
  • Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support(Change from baseline to 12 weeks)
  • Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support(Change from baseline to 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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