Clinical Trials Logo
  1. Home
  2. Bronchiectasis
  3. NCT02048397

Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis — FIM-BRO-2013  

Bronchiectasis Clinical Trial

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 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).

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02048397
Study type Interventional
Source Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date December 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT05034900 - Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis? N/A
Recruiting NCT04101448 - Prevalence of Bronchiectasis in COPD Patients
Withdrawn NCT03376204 - Pain Mechanisms in Patients With Bronchiectasis
Completed NCT02550821 - Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
Completed NCT02656992 - Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis N/A
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT02282202 - Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD N/A
Recruiting NCT01761214 - Bacteriology and Inflammation in Bronchiectasis N/A
Recruiting NCT02527486 - Seoul National University Airway Registry N/A
Completed NCT01578681 - ELTGOL and Bronchiectasis. Respiratory Therapy N/A
Completed NCT01854788 - 3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis N/A
Completed NCT00769119 - A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis Phase 2
Completed NCT01117493 - Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis N/A
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Recruiting NCT00129350 - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation Phase 1
Completed NCT00656721 - Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients N/A
Completed NCT04081740 - Biological Determinants of Sputum Rheology in Chronic Airway Diseases
Enrolling by invitation NCT02546297 - Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis Phase 4
Completed NCT03628456 - Effect of HFCWO Vests on Spirometry Measurements N/A
Completed NCT03750734 - Target Validation and Discovery in Idiopathic Bronchiectasis