Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis

Not Applicable

Completed

• Conditions: Bronchiectasis
• Interventions: Dietary Supplement: Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate; Other: Pulmonary Rehabilitation

• Registration Number: NCT02048397
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary

The effect of Pulmonary Rehabilitation in patients with bronchiectasis (BC) is not sufficiently studied. The aim of this study is to assess the clinical and biological response of a Pulmonary Rehabilitation Program (PRP) for 12 weeks in BC vs PRP plus hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB).

Methods: single center randomized controlled trial, parallel treatment design: Participants will be randomized assigned either will receive (n=14) PRP for 60 minutes, two supervised sessions per week in the hospital and one unsupervised session at home vs PRP (n=14) plus ONS (one can per day).

Outcome assessments will be performed at baseline, 12 weeks and 24 weeks:

1.- effort capacity \–cardiopulmonary exercise test-, 2.- body composition (anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance, phase angle), 3.- peripheral muscle strength (dynamometry and respiratory -PEM (maximum expiratory pressure)and PIM (minimum expiratory pressure)-), 4.- spirometry, 5.- respiratory symptoms (bronchorrhea, dyspnoea, exacerbations),6.- level of physical activity (IPAQ questionnaire plus objective physical activity (WGT3X)), 7.- quality of life (QOL-B-Spain) , 8.-psychological symptoms (HASD) and 9.- biological markers of inflammation (leptin, adiponectin, interleukin-6, tumor necrosis factor-alpha, ultrasensitive C-reactive protein, GPR55 (G protein-coupled receptor 55) RNAm (messenger ribonucleic acid) expression in white blood cells) and oxidation (total antioxidant capacity, superoxide dismutase activity, 8-iso-prostaglandin F2a, Thiobarbituric acid reactive substances).

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study Start: 2013-09
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-29
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients ages from 18-80 (both included)
• Patients with bronchiectasis, not cystic fibrosis bronchiectasis.
• Bronchiectasis diagnosed by high resolution computed tomography (HRCT). of the chest
• Patients followed in Bronchiectasis and Cystic Fibrosis Units in the Hospital.
• BMI > 18.5 in patients under 65 years old, and > 20kg/m2 in patients over this age.
• Ambulatory patients.

Exclusion Criteria

• Use of oral corticoids.
• Respiratory exacerbation. If a patient had a respiratory exacerbation or a recent hospital admission, their participation will be postponed for at least 60 days til any acute disease is resolved.
• Prior oral or parenteral supplements intake.
• Traumatological, neurological or cardiovascular diseases that prevent patients from performing the training.
• Life threatening hemoptysis in the past year.
• Patients with cancer, major surgery in the previous three months, participating in another study, patients who are pregnant or may become pregnant, patients with acute intestinal disease, acute heart failure, severe hepatic failure or dialysis.
• Gastrectomy, gastroparesis or other alterations of gastric emptying.
• Enteral tube feeding, galactosemia, Fructosemia.
• Allergy or known sensitivity to any ingredient of the enteral formula.
• Cystic fibrosis.
• Included in active list for transplantation.
• Drug or alcohol abuse.
• No informed consent signed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation plus oral nutritional supplement	Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate	Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB)
Pulmonary Rehabilitation (PRP)	Pulmonary Rehabilitation	Pulmonary Rehabilitation (PRP)

Primary Outcome Measures

Name	Time	Method
Change in oxygen uptake at peak exercise (VO2max) in cardiopulmonary exercise test (Before and after Rehabilitation-at 3 and 6 months)	3rd and 6th month visits

Secondary Outcome Measures

Name	Time	Method
Body composition	3rd and 6th month visits	Anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance.

Trial Locations

Locations (1)

Gabriel Olveira; 🇪🇸 Malaga, Spain