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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Dietary Supplements, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Whey protein
Maltodextrin
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring Whey Protein

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Whey protein + Rehabilitation

Placebo + Rehabilitation

Control

Arm 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).

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).

Patients without pulmonary rehabilitation nor whey protein supplementation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Muscle strength through manual grip strength of dominant and non-dominant limbs
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.
Body composition (amount of muscle mass) wiht absorptiometry by dual emission of X-ray
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.
Tissue functionality through phase angle
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.

Full Information

First Posted
December 5, 2017
Last Updated
July 28, 2023
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03386604
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
March 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Dietary Supplements, Rehabilitation
Keywords
Whey Protein

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey protein + Rehabilitation
Arm Type
Experimental
Arm 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).
Arm Title
Placebo + Rehabilitation
Arm Type
Placebo Comparator
Arm 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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients without pulmonary rehabilitation nor whey protein supplementation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
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
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin energy value 160 kcal.
Primary Outcome Measure Information:
Title
Physical capacity through the maximum distance traveled
Description
The test will be performed during 6 minutes on a previously measured surface with a distance of 30m, without additional oxygen support.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Muscle strength through manual grip strength of dominant and non-dominant limbs
Description
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.
Time Frame
8 weeks
Title
Body composition (amount of muscle mass) wiht absorptiometry by dual emission of X-ray
Description
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.
Time Frame
8 weeks
Title
Tissue functionality through phase angle
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina G De Souza, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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