Elsevier

Clinical Nutrition

Volume 39, Issue 2, February 2020, Pages 405-413
Clinical Nutrition

Randomized Control Trials
Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial

https://doi.org/10.1016/j.clnu.2019.03.001Get rights and content
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Summary

Background and aims

The efficacy of nutritional intervention to enhance short- and long-term outcomes of pulmonary rehabilitation in COPD is still unclear, hence this paper aims to investigate the clinical outcome and cost-effectiveness of a 12-month nutritional intervention strategy in muscle-wasted COPD patients.

Methods

Prior to a 4-month pulmonary rehabilitation programme, 81 muscle-wasted COPD patients (51% males, aged 62.5 ± 0.9 years) with moderate airflow obstruction (FEV1 55.1 ± 2.2% predicted) and impaired exercise capacity (Wmax 63.5 ± 2.4% predicted) were randomized to 3 portions of nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO (phase 1). In the unblinded 8-month maintenance phase (phase 2), both groups received structured feedback on their physical activity level assessed by accelerometry. NUTRITION additionally received 1 portion of supplemental nutrition per day and motivational interviewing-based nutritional counselling. A 3-month follow-up (phase 3) was included.

Results

After 12 months, physical capacity measured by quadriceps muscle strength and cycle endurance time were not different, but physical activity was higher in NUTRITION than in PLACEBO (Δ1030 steps/day, p = 0.025). Plasma levels of the enriched nutrients (p < 0.001) were higher in NUTRITION than PLACEBO. Trends towards weight gain in NUTRITION and weight loss in PLACEBO led to a significant between-group difference after 12 months (Δ1.54 kg, p = 0.041). The HADS anxiety and depression scores improved in NUTRITION only (Δ-1.92 points, p = 0.037). Generic quality of life (EQ-5D) was decreased in PLACEBO but not in NUTRITION (between-group difference after 15 months 0.072 points, p = 0.009). Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months; only amotivation towards healthy eating yielded a significant between-group difference (Δ1.022 points, p = 0.015). The cost per quality-adjusted life-year after 15 months was EUR 16,750.

Conclusions

Nutritional intervention in muscle-wasted patients with moderate COPD does not enhance long-term outcome of exercise training on physical capacity but ameliorates plasma levels of the supplemented nutrients, total body weight, physical activity and generic health status, at an acceptable increase of costs for patients with high disease burden.

Keywords

COPD
Physical activity
Cost-effectiveness
Nutritional intervention

Abbreviations

BMI
Body mass index
BREQ-2
Behavioural Regulation in Exercise Questionnaire-2
CET
Cycle endurance time
COPD
Chronic obstructive pulmonary disease
DEXA
Dual energy x-ray absorptiometry
DHA
Docosahexaenoic acid
DLCO
Diffusion capacity of the lung for carbon monoxide
EPA
Eicasopentaenoic acid
EQ-5D-3L
EuroQol Five-Dimensions Questionnaire
FEV1
Forced expiratory volume in 1 s
FVC
Forced vital capacity
FFMI
Fat-free mass index
HADS
Hospital Anxiety and Depression Scale
ICER
Incremental cost-effectiveness ratio
MI
Motivational interviewing
PA
Physical activity
PAL
physical activity level
PR
Pulmonary rehabilitation
PUFA
Polyunsaturated fatty acids
QALY
Quality-adjusted life year
QMS
Quadriceps muscle strength
REBS
Regulation of Eating Behaviour Scale
SDT
Self-determination theory
SGRQ
St George's Respiratory Questionnaire

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