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Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease With and Without Supplementation of Whey

H

Hospital de Clinicas de Porto Alegre

Status

Completed

Conditions

Rehabilitation
Pulmonary Disease, Chronic Obstructive
Dietary Supplements

Treatments

Dietary Supplement: Whey protein
Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Other

Identifiers

NCT03386604
72793717.0.0000.5327

Details and patient eligibility

About

Chronic obstructive pulmonary disease is characterized by obstruction to pulmonary airflow and dyspnea. These characteristics are a consequence of exposure to harmful gases and particles that lead to oxidative stress in the lungs together with an exaggerated inflammatory response. In addition to respiratory impairment, chronic obstructive pulmonary disease has systemic manifestations, nutritional alterations, and exercise limitation. Pulmonary rehabilitation is one of the most effective interventions in the treatment of chronic obstructive pulmonary disease, with one goal being to improve patient capacity. Whey protein supplementation, concomitant with physical activity for patients with chronic obstructive pulmonary disease, aims to stimulate protein synthesis and decrease muscle catabolism that may be caused by exercise. The investigators aimed to evaluate the effects of whey protein supplementation supplementation on the physical capacity, body composition and tissue functionality of patients with chronic obstructive pulmonary disease in a pulmonary rehabilitation program.

Full description

A randomized clinical study will be carried out with 62 patients (31 patients per group) with chronic obstructive pulmonary disease who came from specialized departments of the Pulmonology Service of the Hospital de Clínicas of Porto Alegre and were referred to the pulmonary rehabilitation program of this institution. Patients will be evaluated in relation to anthropometry, body composition, blood biochemistry, phase angle, dietary intake, physical capacity, muscle strength and lung function. The data will be processed in the statistical program SPSS version 17.0 and for statistical analysis they will be tested for their normality by the Kolmogorov-Smirnoff test and after this definition will be applied specific tests for parametric or non-parametric data, being they presented in the form of mean and standard deviation or median, minimum and maximum, according to their distribution. The differences will be considered significant for values of p <0.05.

Enrollment

32 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have been referred for pulmonary rehabilitation for chronic obstructive pulmonary disease diagnosis;
  • Stable for the last 3 months and have no contraindications to exercise (no infection, acute myocardial infarction, malignant neoplasms, renal or hepatic disease, ascites / edema or neuromuscular disease);
  • Be 40 years or older;
  • Being literate;

Exclusion criteria

  • Being a vegetarian;
  • Make use of continuous oxygen;
  • Present cognitive or functional changes that limit the execution of any of the proposed tests.
  • Body mass index <21.0 kg / m² and ≥ 35.0 kg / m².

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

32 participants in 3 patient groups, including a placebo group

Whey protein + Rehabilitation
Experimental group
Description:
Pulmonary rehabilitation will last 8 weeks covering 3 weekly sessions of supervised exercise and a weekly educational session. Patients will receive whey protein and will be instructed to take it daily for breakfast, diluted in milk or water (if they do not drink milk).
Treatment:
Dietary Supplement: Whey protein
Placebo + Rehabilitation
Placebo Comparator group
Description:
Pulmonary rehabilitation will last 8 weeks covering 3 weekly sessions of supervised exercise and a weekly educational session. Patients will receive placebo (maltodextrin) and will be instructed to take it daily for breakfast, diluted in milk or water (if they do not drink milk).
Treatment:
Dietary Supplement: Maltodextrin
Control
No Intervention group
Description:
Patients without pulmonary rehabilitation nor whey protein supplementation.

Trial contacts and locations

1

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Central trial contact

Priscila B Zanella, MD

Data sourced from clinicaltrials.gov

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