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| Name | Class |
|---|---|
| Fundación Pública Andaluza Progreso y Salud | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Rehabilitation (PRP) | Other | Pulmonary Rehabilitation (PRP) |
|
| Pulmonary Rehabilitation plus oral nutritional supplement | Other | Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Rehabilitation | Other |
| ||
| Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance. | 3rd and 6th month visits |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral muscle strength | Dynamometry | 3rd and 6th month visits |
| Change from baseline in respiratory symptoms (bronchorrhea, dyspnea, exacerbations) at 6 months. | 3rd and 6th month visits |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GABRIEL OLVEIRA, MD, PhD | Andaluz Health Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriel Olveira | Málaga | Malaga | 29009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Clin Nutr. 2015 Oct 19. pii: S0261-5614(15)00255-1. doi: 10.1016/j.clnu.2015.10.001. [Epub ahead of print] | ||
| 29952809 | Derived | 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. | |
| 29656933 |
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| Dietary Supplement |
|
| Level of physical activity | IPAQ questionnaire plus objective physical activity | 3rd and 6th month visits |
| Quality of life | QOL-B-Spain | 3rd and 6th month visits |
| biological markers of Biological markers of inflammation and oxidation | 3rd and 6th month visits |
| Derived |
| 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. |
| 26522923 | Derived | 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. |
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C004961 | beta-hydroxyisovaleric acid |
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