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

Bronchiectasis Clinical Trial

— FIM-BRO-2013  

Official title:

A Pilot Study of Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048397
• Other study ID #: FIM-BRO-2013-01
• Status: Completed
• Phase: N/A
• First received: January 15, 2014
• Last updated: March 15, 2016
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• Pulmonary Rehabilitation

Dietary Supplement:
• Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate

Locations

Country	Name	City	State
Spain	Gabriel Olveira	Malaga

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Clin Nutr. 2015 Oct 19. pii: S0261-5614(15)00255-1. doi: 10.1016/j.clnu.2015.10.001. [Epub ahead of print]

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peripheral muscle strength	Dynamometry	3rd and 6th month visits	No
Other	Change from baseline in respiratory symptoms (bronchorrhea, dyspnea, exacerbations) at 6 months.		3rd and 6th month visits	No
Other	Level of physical activity	IPAQ questionnaire plus objective physical activity	3rd and 6th month visits	No
Other	Quality of life	QOL-B-Spain	3rd and 6th month visits	No
Other	biological markers of Biological markers of inflammation and oxidation		3rd and 6th month visits	No
Primary	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	No
Secondary	Body composition	Anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance.	3rd and 6th month visits	No