Protein Supplementation to Enhance Exercise Capacity in COPD

COPD Clinical Trial

Official title:

A Double-Blind, Randomised, Placebo-Controlled Trial of Protein Supplementation to Enhance Exercise Capacity in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027413
• Other study ID #: 18/LO/1842
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: October 2, 2020

Study information

• Verified date: October 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• COPD

Intervention

Dietary Supplement:
• fortisip compact protein
(24% protein; 41% carbohydrate; 35% fat)
• preOp
(100% carbohydrate).

Locations

Country	Name	City	State
United Kingdom	Central and North West London Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Nutricia, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Peripheral muscle strength	The difference in change of peripheral muscle strength Before and and after pulmonary rehabilitation between intervention and control groups measured by Hand Dynamometer.	12 weeks
Secondary	Rectus femoris muscle cross-sectional	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.	12 weeks
Secondary	Body composition	The difference in change of body composition fat mass (FM) before and and after pulmonary rehabilitation between intervention and control groups measured by a device called Bodystat.	12 weeks
Secondary	Physical activity	The difference in change of physical activity before and and after pulmonary rehabilitation between intervention and control groups measured by step-counter (YAMAX SW200).	14 days
Secondary	Health-related quality of life	The difference in change of health-related quality before and after pulmonary rehabilitation between intervention and control groups measured by Hospital Anxiety and Depression Scale. consists of seven items for anxiety and seven items for depression, each item has a score from 0-3.This means that a person can score between 0 and 21 for either abnormal, respectively. 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal	12 weeks
Secondary	Body circumferences	The difference in change of waist circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.	12 weeks
Secondary	Body composition	The difference in change of body composition fat free mass (FFM) before and and after pulmonary rehabilitation between intervention and control groups measured by a device called Bodystat.	12 weeks
Secondary	Body composition	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.	12 weeks
Secondary	Body circumferences	The difference in change of hip circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.	12 weeks
Secondary	Body circumferences	The difference in change of mid-thigh circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.	12 weeks
Secondary	Health-related quality of life	The difference in change of health-related quality before and after pulmonary rehabilitation between intervention and control groups measured by the COPD Assessment Test Questionnaire.	12 weeks
Secondary	Health-related quality of life	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.	12 weeks
Secondary	intervention compliance	participants intervention compliance will be assessed by sheet	6 weeks
Secondary	Food intake	Food intake for 3 consecutive days before, during, and after PR by food diary	12 weeks
Secondary	Lower limb function	The difference in change of lower limb function before and after pulmonary rehabilitation between intervention and control groups measured Sit to Stand - Five Test.	12 weeks
Secondary	Malnutrition risk	The difference in change of Malnourished risk before and after pulmonary rehabilitation between intervention and control groups measured Malnutrition Universal Screening Tool .	12 weeks
Secondary	Disability associated with breathlessness	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 .	12 weeks
Secondary	Body weight	The difference in change of body weight before and after pulmonary rehabilitation between intervention and control groups measured by digital scales.	12 weeks