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

March 15, 2016 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Malaga, Spain, 29009
        • Gabriel Olveira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pulmonary Rehabilitation (PRP)
Other: Pulmonary Rehabilitation
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3rd and 6th month visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 3rd and 6th month visits
Anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance.
3rd and 6th month visits

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral muscle strength
Time Frame: 3rd and 6th month visits
Dynamometry
3rd and 6th month visits
Change from baseline in respiratory symptoms (bronchorrhea, dyspnea, exacerbations) at 6 months.
Time Frame: 3rd and 6th month visits
3rd and 6th month visits
Level of physical activity
Time Frame: 3rd and 6th month visits
IPAQ questionnaire plus objective physical activity
3rd and 6th month visits
Quality of life
Time Frame: 3rd and 6th month visits
QOL-B-Spain
3rd and 6th month visits
biological markers of Biological markers of inflammation and oxidation
Time Frame: 3rd and 6th month visits
3rd and 6th month visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Collaborators

Fundación Pública Andaluza Progreso y Salud

Investigators

  • Principal Investigator: GABRIEL OLVEIRA, MD, PhD, Andaluz Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIM-BRO-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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