Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease With and Without Supplementation of Whey
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|ClinicalTrials.gov Identifier: NCT03386604|
Recruitment Status : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive Dietary Supplements Rehabilitation||Dietary Supplement: Whey protein Dietary Supplement: Maltodextrin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease in Pulmonary Rehabilitation With and Without Supplementation of Whey|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: 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).
Dietary Supplement: 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.
Placebo Comparator: 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).
Dietary Supplement: Maltodextrin
Maltodextrin energy value 160 kcal.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386604
|Contact: Priscila B Zanella, MD||55 51 firstname.lastname@example.org|
|Principal Investigator:||Carolina G De Souza, PhD||Hospital de Clinicas de Porto Alegre|