Clinical trial NCT04027413: Protein Supplementation to Enhance Exercise Capacity in COPD
Official title: A Double-Blind, Randomised, Placebo-Controlled Trial of Protein Supplementation to Enhance Exercise Capacity in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Pulmonary Rehabilitation
Nutrtional supplements
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Nutricia, Inc.
First posted: 2019-07-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised using a web-based service called 'sealed envelope' and stratified BMI less and equal or more than 20 kg/m2 to control group or interventional group.
Primary purpose: DIAGNOSTIC

Brief summary: Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.

Pulmonary Rehabilitation (PR) is a six-week supervised group exercise and education class. PR is an effective intervention in COPD to reduce symptoms, improve exercise performance and prevent exacerbation. Exercise intolerance/limitation is one of the commonest issues with COPD patients and this may be compounded by reduced muscle mass and malnutrition. COPD patients lose body weight and skeletal muscle mass which leads to muscle weakness and dysfunction, thus impacting functional ability and quality of life. Muscle weakness is caused by a prolonged sedentary lifestyle and voluntary immobilization. Importantly, being under-weight is associated with an increased risk of mortality in COPD.

Nutritional supplementation have been used to overcome malnutrition in COPD patients. It has been shown that nutritional support integrated with exercise training can improve exercise activity, decreased the risk of mortality, and improve muscle strength in undernourished COPD patients. However, uptake of nutritional supplementation during pulmonary rehabilitation, where the potential benefit may be greatest, has been limited by the absence of rigorous evidence-based studies supporting use.

Investigators want to investigate the effect of a nutritional supplement during a PR program on exercise capacity in COPD patients. Investigators will collect demographic data, distribute questionnaires, measure exercise performance, and some additional measurements.


Eligibility criteria: Inclusion Criteria:

1. Confirmed COPD (post-bronchodilator forced vital capacity in one second: forced vital capacity ratio \<0.7)
2. \>10 smoking pack year history.
3. Enrolling on a pulmonary rehabilitation programme.
4. Age of 18 and above.

Exclusion Criteria:

1. Patients with any physical or mental health disorders preventing compliance with trial protocol.
2. Unable to communicate in English
3. Malabsorption syndrome
4. Unable to perform the Incremental Shuttle Walk Test
5. Patients already using other types of oral dietary supplement, under the care of a dietitian.
6. Galactosaemia (contraindication)
7. Known cow's milk protein allergy or lactose intolerance
8. BMI \>30kg/m2 without recent weight loss of \>5%

Primary outcomes:
measure: Exercise capacity
timeFrame: 12 weeks
Secondary outcomes:
measure: Peripheral muscle strength
timeFrame: 12 weeks
measure: Rectus femoris muscle cross-sectional
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 14 days
measure: Health-related quality of life
timeFrame: 12 weeks
measure: Body circumferences
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Body circumferences
timeFrame: 12 weeks
measure: Body circumferences
timeFrame: 12 weeks
measure: Health-related quality of life
timeFrame: 12 weeks
measure: Health-related quality of life
timeFrame: 12 weeks
measure: intervention compliance
timeFrame: 6 weeks
measure: Food intake
timeFrame: 12 weeks
measure: Lower limb function
timeFrame: 12 weeks
measure: Malnutrition risk
timeFrame: 12 weeks
measure: Disability associated with breathlessness
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Central and North West London Foundation Trust
Study officials:
References: