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

NCT ID: NCT03386604

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2022-03-02

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Dietary Supplements; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Whey protein + Rehabilitation

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).

Group Type: EXPERIMENTAL

Whey protein

Intervention Type: DIETARY_SUPPLEMENT

whey protein 40 g: energy value 160 kcal; carbohydrate 10 g; 25g proteins; total fat 2.3g; saturated fats 1.1 g; trans fat 0 g; dietary fiber 0 g; sodium 157 mg; calcium 264 mg.

Placebo + Rehabilitation

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).

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin energy value 160 kcal.

Control

Patients without pulmonary rehabilitation nor whey protein supplementation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Whey protein

whey protein 40 g: energy value 160 kcal; carbohydrate 10 g; 25g proteins; total fat 2.3g; saturated fats 1.1 g; trans fat 0 g; dietary fiber 0 g; sodium 157 mg; calcium 264 mg.

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin energy value 160 kcal.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolina G De Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

72793717.0.0000.5327

Identifier Type: -

Identifier Source: org_study_id