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NCT Number: NCT04027413

Protein Supplementation to Enhance Exercise Capacity in COPD

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central and North West London Foundation Trust

London, NW1 0PE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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%

Treatment and study plan

fortisip compact protein

Dietary Supplement

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

PREOP

Dietary Supplement

(100% carbohydrate).

Primary outcomes

  1. Exercise capacity

    Time frame: 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 outcomes

  1. Peripheral muscle strength

    Time frame: 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.

  2. Rectus femoris muscle cross-sectional

    Time frame: 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.

  3. Body composition

    Time frame: 12 weeks

    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.

  4. Physical activity

    Time frame: 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).

  5. Health-related quality of life

    Time frame: 12 weeks

    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

  6. Body circumferences

    Time frame: 12 weeks

    The difference in change of waist circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.

  7. Body composition

    Time frame: 12 weeks

    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.

  8. Body composition

    Time frame: 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.

  9. Body circumferences

    Time frame: 12 weeks

    The difference in change of hip circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.

  10. Body circumferences

    Time frame: 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.

  11. Health-related quality of life

    Time frame: 12 weeks

    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. Health-related quality of life

    Time frame: 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.

  13. intervention compliance

    Time frame: 6 weeks

    participants intervention compliance will be assessed by sheet

  14. Food intake

    Time frame: 12 weeks

    Food intake for 3 consecutive days before, during, and after PR by food diary

  15. Lower limb function

    Time frame: 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.

  16. Malnutrition risk

    Time frame: 12 weeks

    The difference in change of Malnourished risk before and after pulmonary rehabilitation between intervention and control groups measured Malnutrition Universal Screening Tool .

  17. Disability associated with breathlessness

    Time frame: 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 .

  18. Body weight

    Time frame: 12 weeks

    The difference in change of body weight before and after pulmonary rehabilitation between intervention and control groups measured by digital scales.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Nutricia, Inc.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 22, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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