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NCT Number: NCT02048397

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

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).

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gabriel Olveira

Málaga, Malaga, 29009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary Rehabilitation

Other

Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate

Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. Body composition

    Time frame: 3rd and 6th month visits

    Anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance.

Other outcomes

  1. Peripheral muscle strength

    Time frame: 3rd and 6th month visits

    Dynamometry

  2. Change from baseline in respiratory symptoms (bronchorrhea, dyspnea, exacerbations) at 6 months.

    Time frame: 3rd and 6th month visits

  3. Level of physical activity

    Time frame: 3rd and 6th month visits

    IPAQ questionnaire plus objective physical activity

  4. Quality of life

    Time frame: 3rd and 6th month visits

    QOL-B-Spain

  5. biological markers of Biological markers of inflammation and oxidation

    Time frame: 3rd and 6th month visits

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Fundación Pública Andaluza Progreso y Salud

Registry information

Official study title

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

Acronym: FIM-BRO-2013

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2014
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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