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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00009755 |
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Date of registration:
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29/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Chronic effects of eccentric cycling on systemic inflammation, oxidative stress, muscle function, and metabolic disease biomarkers in COPD patients
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Scientific title:
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Chronic effects of eccentric cycling on systemic inflammation, oxidative stress, muscle function, and metabolic disease biomarkers in COPD patients - ECC and COPD |
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Date of first enrolment:
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03/04/2016 |
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Target sample size:
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45 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00009755 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Chile
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Contacts
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Name:
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Santiago
Aranguiz |
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Address:
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1509 Pedro de Valdivia Av.
7501015
Santiago
Chile |
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Telephone:
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(+56) 2 2420 7226 |
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Email:
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saranguiz@uft.cl |
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Affiliation:
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Universidad Finis Terrae |
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Name:
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Hermann
Zbinden |
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Address:
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1509 Pedro de Valdivia
7501015
Santiago
Chile |
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Telephone:
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+56(2)224207574 |
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Email:
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hzbinden@uft.cl |
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Affiliation:
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Universidad Finis Terrae |
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Key inclusion & exclusion criteria
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Inclusion criteria: All participants will obtain medical clearance from a physician before taking part in the current study.
Participants will have no history of participating in any structured exercise training program designed to improve leg strength or power over the previous 6 months, and will be willing to undertake 16 weeks of training without interruption and attend all testing sessions.
Exclusion criteria: Exclusion criteria will include current insulin therapy, long-term oxygen therapy, asthma, other concomitant pulmonary diseases or other diseases that could affect physical activity, such as neurological diseases, kidney diseases, symptomatic cardiovascular diseases, left cardiomyopathy, musculoskeletal and neuromuscular diseases. Also, illness that could cause death within 6 months, inability to perform the tests, unstable angina or congestive heart failure stage III or IV will be considered exclusion criteria (Gutie´rrez et al., 2007; Pavie´ et al., 2011).
Age minimum:
40 Years
Age maximum:
90 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Other chronic obstructive pulmonary disease
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CHRONIC OBSTRUCTIVE PULMONARY DISEASE
J44
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Intervention(s)
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Group 1: A 16-week eccentric training. Training session will be carried out 3 times per week. They will start from 5 min and progress up to 30 min of cycling. Intensity will be progressively increased from 30 to 50% Vo2max.
Group 2: A 16-week conventional training program (endurance). Training session will be carried out 3 times per week. They will start from 5 min and progress up to 30 min of cycling. Intensity will be progressively increased from 30 to 50% Vo2max.
Group 3: A 16-week conventional strength training program (resistance). Training session will be carried out 3 times per week. Patients will perform 3-4 sets of 12-8 RM. Exercise will include leg press, squat and leg extension exercises. Intensity will be progressively increased from 50 to 80% of 1RM.
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Primary Outcome(s)
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To investigate the health benefits after 16 weeks of three different exercise modalities (eccentric cycling, concentric cycling and resistance training) on the oxidative stress (plasma TBARS,total glutathione, gluthatione peroxidase, protein carbonyl and total antioxidant capacity) chronic inflammation (TNF-alpha, IL-1 and IL-6) and metabolic disease (Glycemic control, insulin sensitibity, lipid profile, body composition, muscle function) biomarkers of patients with COPD. Measurements will be performed before and 72 h after the completion of 16 weeks of training.
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Secondary Outcome(s)
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Examine the changes in muscle strength and endurance before and 72 h after the completion of 16 weeks of training. Knee extensor muscle strength will be assessed by maximal isometric voluntary contractions at 70º of knee flexion. Endurance will be assessed by a time trial test in a concentric ergometer assessed as the maximum time last cycling at 80% of the VO2max.
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Secondary ID(s)
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U1111-1181-2272
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 20/12/2015
Contact:
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