Protein Supplementation to Enhance Exercise Capacity in COPD

NCT04027413 | Completed

• 1 other identifier: 18/LO/1842
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Pulmonary Rehabilitation; Nutrtional supplements

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  The difference in change of exercise capacity before and and after pulmonary rehabilitation between intervention and control groups measured by Incremental Shuttle Walk Test.

  12 weeks

Secondary Outcomes (18)

• Peripheral muscle strength

  12 weeks

• Rectus femoris muscle cross-sectional

  12 weeks

• Body composition

  12 weeks

• Physical activity

  14 days

• Health-related quality of life

  12 weeks

Study Arms (2)

Placebo/ Control

PLACEBO COMPARATOR

participants in this group will receive carbohydrate product which does not include protein at all

Dietary Supplement: preOp

Intervention group

EXPERIMENTAL

Participants in this group will receive high protein product

Dietary Supplement: fortisip compact protein

Interventions

fortisip compact protein DIETARY_SUPPLEMENT

(24% protein; 41% carbohydrate; 35% fat)

Intervention group

preOp DIETARY_SUPPLEMENT

(100% carbohydrate).

Placebo/ Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• Nutricia, Inc.: collaborator

Study Sites (1)

Central and North West London Foundation Trust

London, NW1 0PE, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant in both groups will received either the supplement or the placebo/ control products. Both products will be labelled the same way. Investigator: someone not from the research team will run the randomisation and deliver the products to participants. Outcome Assessor: will not be involved in the randomisation and will be blinded
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 22, 2019
• Study Start: January 7, 2019
• Primary Completion: March 23, 2020
• Study Completion: October 2, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

GB (1)