Clinical trial NCT03386604: Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease With and Without Supplementation of Whey
Official title: Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease in Pulmonary Rehabilitation With and Without Supplementation of Whey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Dietary Supplements
Rehabilitation
Keywords: Whey Protein
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical capacity through the maximum distance traveled
timeFrame: 8 weeks
Secondary outcomes:
measure: Muscle strength through manual grip strength of dominant and non-dominant limbs
timeFrame: 8 weeks
measure: Body composition (amount of muscle mass) wiht absorptiometry by dual emission of X-ray
timeFrame: 8 weeks
measure: Tissue functionality through phase angle
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Carolina G De Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References: