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NCT Number: NCT03386604

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Dietary Supplements Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Rehabilitation Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whey Protein

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.

Maltodextrin

Dietary Supplement

Maltodextrin energy value 160 kcal.

Primary outcomes

  1. Physical capacity through the maximum distance traveled

    Time frame: 8 weeks

    The test will be performed during 6 minutes on a previously measured surface with a distance of 30m, without additional oxygen support.

Secondary outcomes

  1. Muscle strength through manual grip strength of dominant and non-dominant limbs

    Time frame: 8 weeks

    Measurement of grip strength with dynamometer is performed with the patient sitting comfortably, with the shoulder attached, the elbow flexed at 90º, the forearm in the neutral position and the cuff should be between 0 (zero) and 30º of extension, and should perform the greatest gripping force possible. Six measurements will be performed with a 15-second interval, alternating the hands, starting with the dominant upper limb.

  2. Body composition (amount of muscle mass) wiht absorptiometry by dual emission of X-ray

    Time frame: 8 weeks

    The measurements will be obtained with the patient in the supine position, positioned in the area of equipment scanning, so that the sagittal line demarcated in this area passes under the center of some anatomical points such as the skull, spine, pelvis and legs, and without metal objects attached to the body.

  3. Tissue functionality through phase angle

    Time frame: 8 weeks

    The evaluation of the phase angle will be performed by means of the electric bioimpedance apparatus. The measurements will be obtained with the patient in dorsal decubitus, barefoot, with the lower limbs slightly apart and without metal objects attached to the body, with electrodes placed on the right hand and foot. Diuretic medications should be stopped 24 hours before the test, physical activities should be avoided until 8 hours before and a 4 hour fast will be requested.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 29, 2017
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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