Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02261350
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT05043428 - The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD N/A
Completed NCT00528996 - An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler. Phase 2
Completed NCT03740373 - A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate Phase 1
Completed NCT05402020 - Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Completed NCT05393245 - Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
Completed NCT04011735 - Re-usable Respimat® Soft MistTM Inhaler Study
Enrolling by invitation NCT03075709 - The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
Completed NCT03764163 - Image and Model Based Analysis of Lung Disease Early Phase 1
Completed NCT00515268 - Endotoxin Challenge Study For Healthy Men and Women Phase 1
Completed NCT04085302 - TARA Working Prototype Engagement Evaluation: Feasibility Study N/A
Completed NCT03691324 - Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study N/A
Completed NCT02236611 - A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT00153075 - Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT01017952 - A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01009463 - A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT04882124 - Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD Phase 2
Completed NCT02853123 - Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients Phase 4
Completed NCT02619357 - Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma Phase 1
Recruiting NCT05858463 - High Intensity Interval Training and Muscle Adaptations During PR N/A
Not yet recruiting NCT05032898 - Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II