Protein Supplementation to Enhance Exercise Capacity in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2020-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

High Protein Diet and Physical Activity in COPD

NCT04888182

COPD

COMPLETED NA

AECOPD and Nutritional Supplementation in COPD

NCT06801964

Obstructive Pulmonary Disease Exacerbation Copd

COMPLETED NA

Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease With and Without Supplementation of Whey

NCT03386604

Pulmonary Disease, Chronic Obstructive Dietary Supplements Rehabilitation

COMPLETED NA

The Effect of Two Weeks of Voluntary Reduced Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

NCT02221804

Chronic Obstructive Pulmonary Disease (COPD) Muscle Atrophy

UNKNOWN NA

High Protein and Energy Diet for Better Coughing in COPD Patients

NCT03923764

Copd

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo/ Control

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

Group Type PLACEBO_COMPARATOR

preOp

Intervention Type DIETARY_SUPPLEMENT

(100% carbohydrate).

Intervention group

Participants in this group will receive high protein product

Group Type EXPERIMENTAL

fortisip compact protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fortisip compact protein

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

Intervention Type DIETARY_SUPPLEMENT

preOp

(100% carbohydrate).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No