It is known that undernourished COPD patients carry a poor prognosis. We have followed the Medical Research Council's Framework for Complex Interventions and staged our approach across three processes within two years: a systematic literature review, a feasibility study to test the nutritional component, and a pilot randomised controlled trial (RCT) to test the acceptability and feasibility of the whole intervention with a view to plan a future full-scale RCT.
The study on 'Nutritional Rehabilitation in stable COPD' is an ongoing collaborative work of Doncaster and Bassetlaw NHS Foundation Trust and CLAHRC SY. The overarching aim of the study is to find out whether nutritional support and pulmonary rehabilitation exercise programme (PR) will improve nutritional status and health outcomes in COPD.
The feasibility study aimed at designing and evaluating the nutritional component of the intervention. A mixed quantitative and qualitative methodology was used. The research team sought input from eight focus groups formed by 15 underweight COPD patients, ten carers and 16 healthcare professionals. The team concluded that the nutritional intervention should be an individualised dietetic consultation with 'food first' approach, incorporating food fortification, snacks and/or sip-feeds. The intervention was then tested for three weeks and the acceptability and adherence were assessed.
With the three week intervention, a trend towards an increase in daily calorie intake with a mean difference of 773 calories per day was observed. Focus group feedback confirmed that the programme was acceptable.
The pilot RCT is ongoing. The trial intends to test the important components of the definitive trial such as retention rate and acceptability. A number of 40 participants were recruited, with the intervention group receiving the evaluated nutritional intervention and pulmonary rehabilitation exercise programme, and the control group receiving the exercise programme only. The design of the pilot study has also been informed by the literature review. As previous studies on nutritional supplementation in COPD have included a wider range of participants over a shorter period, in this pilot study the researchers have recruited only underweight participants aiming for a substantial additional calorie increase (600 calories) and the interventional duration is set at three months with three months of follow up.