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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor:
Collaborator:
Fundación Pública Andaluza Progreso y Salud
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier:
NCT02048397
First received: January 15, 2014
Last updated: January 29, 2014
Last verified: August 2013
  Purpose

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).


Condition Intervention
Bronchiectasis
Other: Pulmonary Rehabilitation
Dietary Supplement: Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:

Primary Outcome Measures:
  • Change in oxygen uptake at peak exercise (VO2max) in cardiopulmonary exercise test (Before and after Rehabilitation-at 3 and 6 months) [ Time Frame: 3rd and 6th month visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 3rd and 6th month visits ] [ Designated as safety issue: No ]
    Anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance.


Other Outcome Measures:
  • Peripheral muscle strength [ Time Frame: 3rd and 6th month visits ] [ Designated as safety issue: No ]
    Dynamometry

  • Change from baseline in respiratory symptoms (bronchorrhea, dyspnea, exacerbations) at 6 months. [ Time Frame: 3rd and 6th month visits ] [ Designated as safety issue: No ]
  • Level of physical activity [ Time Frame: 3rd and 6th month visits ] [ Designated as safety issue: No ]
    IPAQ questionnaire plus objective physical activity

  • Quality of life [ Time Frame: 3rd and 6th month visits ] [ Designated as safety issue: No ]
    QOL-B-Spain

  • biological markers of Biological markers of inflammation and oxidation [ Time Frame: 3rd and 6th month visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: September 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pulmonary Rehabilitation (PRP)
Pulmonary Rehabilitation (PRP)
Other: Pulmonary Rehabilitation
Pulmonary Rehabilitation plus oral nutritional supplement
Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB)
Dietary Supplement: Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048397

Contacts
Contact: GABRIEL OLVEIRA, MD, PhD 34951290305 gabrielm.olveira.sspa@juntadeandalucia.es
Contact: FRANCISCA LINARES, MD 34951290305 curra.linares@gmail.com

Locations
Spain
Gabriel Olveira Recruiting
Malaga, Spain, 29009
Contact: GABRIEL OLVEIRA, MD, PhD    34951290305    gabrielm.olveira.sspa@juntadeandalucia.es   
Principal Investigator: GABRIEL OLVEIRA, MD, PhD         
Sub-Investigator: CASILDA OLVEIRA, MD, PhD         
Sub-Investigator: ROCÍO MARTÍN-VALERO, MD, PhD         
Sub-Investigator: ANTONIO DORADO, MD         
Sub-Investigator: NURIA PORRAS, Grd         
Sub-Investigator: ANA GODOY, MD         
Sub-Investigator: GEMMA ROJO, BD         
Sub-Investigator: FRANCISCO JAVIER PALENQUE, Grd         
Sub-Investigator: ESPERANZA DOÑA, MD         
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Fundación Pública Andaluza Progreso y Salud
Investigators
Principal Investigator: GABRIEL OLVEIRA, MD, PhD Andaluz Health Service
  More Information

No publications provided

Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT02048397     History of Changes
Other Study ID Numbers: FIM-BRO-2013-01
Study First Received: January 15, 2014
Last Updated: January 29, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
Bronchiectasis.

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014