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

NCT03386604 | Completed

• 1 other identifier: 72793717.0.0000.5327
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Dietary Supplements; Rehabilitation

Keywords

Whey Protein

Outcome Measures

Primary Outcomes (1)

• Physical capacity through the maximum distance traveled

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

  8 weeks

Secondary Outcomes (3)

• Muscle strength through manual grip strength of dominant and non-dominant limbs

  8 weeks

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

  8 weeks

• Tissue functionality through phase angle

  8 weeks

Study Arms (3)

Whey protein + Rehabilitation

EXPERIMENTAL

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).

Dietary Supplement: Whey protein

Placebo + Rehabilitation

PLACEBO COMPARATOR

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).

Dietary Supplement: Maltodextrin

Control

NO INTERVENTION

Patients without pulmonary rehabilitation nor whey protein supplementation.

Interventions

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.

Whey protein + Rehabilitation

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin energy value 160 kcal.

Placebo + Rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Whey Proteins; maltodextrin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Carolina G De Souza, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 29, 2017
• Study Start: September 10, 2021
• Primary Completion: November 5, 2021
• Study Completion: March 2, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

BR (1)