Protein Supplementation to Enhance Exercise Capacity in COPD

Not Applicable

Completed

• Conditions: COPD
• Interventions: Dietary Supplement: preOp; Dietary Supplement: fortisip compact protein

• Registration Number: NCT04027413
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-07
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Primary Completion: 2020-03-23
• Status Verified: 2020-10
• Study Completion: 2020-10-02
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/ Control	preOp	participants in this group will receive carbohydrate product which does not include protein at all
Intervention group	fortisip compact protein	Participants in this group will receive high protein product

Primary Outcome Measures

Name	Time	Method
Exercise capacity	12 weeks	The difference in change of exercise capacity before and and after pulmonary rehabilitation between intervention and control groups measured by Incremental Shuttle Walk Test.

Secondary Outcome Measures

Name	Time	Method
Peripheral muscle strength	12 weeks	The difference in change of peripheral muscle strength Before and and after pulmonary rehabilitation between intervention and control groups measured by Hand Dynamometer.
Rectus femoris muscle cross-sectional	12 weeks	The difference in change of Rectus femoris muscle cross-sectional area before and and after pulmonary rehabilitation between intervention and control groups measured by portable ultrasound.
Body composition	12 weeks	The difference in change of body composition fat free mass index (FFMI) before and and after pulmonary rehabilitation between intervention and control groups measured by a device called Bodystat.
Physical activity	14 days	The difference in change of physical activity before and and after pulmonary rehabilitation between intervention and control groups measured by step-counter (YAMAX SW200).
Health-related quality of life	12 weeks	The difference in change of health-related quality before and after pulmonary rehabilitation between intervention and control groups measured by St. George's Respiratory Questionnaire.
Body circumferences	12 weeks	The difference in change of mid-thigh circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.
intervention compliance	6 weeks	participants intervention compliance will be assessed by sheet
Food intake	12 weeks	Food intake for 3 consecutive days before, during, and after PR by food diary
Lower limb function	12 weeks	The difference in change of lower limb function before and after pulmonary rehabilitation between intervention and control groups measured Sit to Stand - Five Test.
Malnutrition risk	12 weeks	The difference in change of Malnourished risk before and after pulmonary rehabilitation between intervention and control groups measured Malnutrition Universal Screening Tool .
Disability associated with breathlessness	12 weeks	The difference in change of Disability associated with breathlessness before and after pulmonary rehabilitation between intervention and control groups measured by Medical Research Council breathlessness scale .
Body weight	12 weeks	The difference in change of body weight before and after pulmonary rehabilitation between intervention and control groups measured by digital scales.

Trial Locations

Locations (1)

Central and North West London Foundation Trust; 🇬🇧 London, United Kingdom