NCT02048397

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 16, 2016

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

January 15, 2014

Last Update Submit

March 15, 2016

Conditions

Bronchiectasis

Keywords

Bronchiectasis.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Body composition

    3rd and 6th month visits

Other Outcomes (5)

  • Peripheral muscle strength

    3rd and 6th month visits

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

    3rd and 6th month visits

  • Level of physical activity

    3rd and 6th month visits

  • +2 more other outcomes

Study Arms (2)

Pulmonary Rehabilitation (PRP)

OTHER

Pulmonary Rehabilitation (PRP)

Other: Pulmonary Rehabilitation

Pulmonary Rehabilitation plus oral nutritional supplement

OTHER

Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB)

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

Interventions

Pulmonary RehabilitationOTHER
Pulmonary Rehabilitation (PRP)
Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrateDIETARY_SUPPLEMENT
Pulmonary Rehabilitation plus oral nutritional supplement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriel Olveira

Málaga, Malaga, 29009, Spain

Location

Related Publications (4)

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

    BACKGROUND

  • Dona E, Olveira C, Palenque FJ, Porras N, Dorado A, Martin-Valero R, Godoy AM, Espildora F, Olveira G. Pulmonary Rehabilitation Only Versus With Nutritional Supplementation in Patients With Bronchiectasis: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2018 Nov;38(6):411-418. doi: 10.1097/HCR.0000000000000341.

    PMID: 29952809DERIVED

  • Dona E, Olveira C, Palenque FJ, Porras N, Dorado A, Martin-Valero R, Godoy AM, Espildora F, Contreras V, Olveira G. Body Composition Measurement in Bronchiectasis: Comparison between Bioelectrical Impedance Analysis, Skinfold Thickness Measurement, and Dual-Energy X-ray Absorptiometry before and after Pulmonary Rehabilitation. J Acad Nutr Diet. 2018 Aug;118(8):1464-1473. doi: 10.1016/j.jand.2018.01.013. Epub 2018 Apr 12.

    PMID: 29656933DERIVED

  • Olveira G, Olveira C, Dona E, Palenque FJ, Porras N, Dorado A, Godoy AM, Rubio-Martinez E, Rojo-Martinez G, Martin-Valero R. Oral supplement enriched in HMB combined with pulmonary rehabilitation improves body composition and health related quality of life in patients with bronchiectasis (Prospective, Randomised Study). Clin Nutr. 2016 Oct;35(5):1015-22. doi: 10.1016/j.clnu.2015.10.001. Epub 2015 Oct 19.

    PMID: 26522923DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

beta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • GABRIEL OLVEIRA, MD, PhD

    Andaluz Health Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 29, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

March 16, 2016

Record last verified: 2013-08

Locations

ES(1)