Chronic effects of eccentric cycling on systemic inflammation, oxidative stress, muscle function, and metabolic disease biomarkers in COPD patients
Organizational Data
- DRKS-ID:
- DRKS00009755
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2016-03-29
- Last update in DRKS:
- 2016-03-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
ECC and COPD
URL of the study
No Entry
Brief summary in lay language
Chronic obstructive pulmonary disease (COPD) is a respiratory disease that is characterised by inflammation and remodelling of the respiratory airways producing a reduced blood oxygenation in the lungs and peripheral muscles, and a diminished expiratory force that maintain a hyperinflation of lungs. Over time, this disease debilitates patients, limiting their normal activities of daily living such as walking or climbing stairs in comparison to healthy individuals. These characteristics also have systemic consequences such as muscle wasting and weakness, and physical inactivity that concomitantly promote the development of comorbidities including type II diabetes and cardiovascular disease. Furthermore, an association between systemic inflammation and oxidative stress with muscle wasting has been proposed as an aggravating factor in COPD. These characteristics of the disease generate a vicious cycle that promotes muscle wasting, inactivity and reduced quality of life due to the low tolerance to exercise in these patients. This project aims to administrate exercise to improve this condition. We will investigate the effect of a particular mode of exercise called eccentric exercise, which is very low in the metabolic demand for patients. We will implement a training study of 16 weeks in order to observe the health benefits of this kind of exercise in comparison to the more convectional exercises that are included in respiratory rehabilitation in COPD patients.
Brief summary in scientific language
Chronic obstructive pulmonary disease (COPD) is a respiratory disease that is characterized by inflammation and remodeling of the respiratory airways producing a reduced blood oxygenation in the lungs and peripheral muscles, and a diminished expiratory force that maintain a hyperinflation of lungs. Over time, this disease debilitates patients, limiting their normal activities of daily living such as walking or climbing stairs in comparison to healthy individuals. These characteristics also have systemic consequences such as muscle wasting and weakness, and physical inactivity that concomitantly promote the development of comorbidities including type II diabetes and cardiovascular disease. Furthermore, an association between systemic inflammation and oxidative stress with muscle wasting has been proposed as an aggravating factor in COPD. These characteristics of the disease generate a vicious cycle that promotes muscle wasting, inactivity and reduced quality of life due to the low tolerance to exercise in these patients. However, pulmonary rehabilitation (i.e. exercise) has shown to improve mobility, functionality and quality of life of COPD patients in all stages of the disease. Typically, endurance exercises have been used to improve exercise tolerance and aerobic capacity. On the other hand, resistance training programs have shown improvements on functionality, mobility and quality of life. Interestingly, eccentric cycling is a more novel exercise modality that has the unique feature of requiring only 35-50% of the oxygen than a concentric cycling exercise (i.e. endurance) to perform the same workload. This characteristic makes of eccentric cycling an ideal exercise modality for patients with limited pulmonary capacity, thus patients can train at higher workloads at a very low cardiopulmonary stress. This allows greater increases in muscle strength and mass when eccentric cycling is performed chronically as training. Additionally, besides increasing muscle mass at low cardiopulmonary demand, eccentric exercise has been prove to be a powerful exercise modality to decrease lipid profiles, markers of systemic inflammation and insulin resistance. In fact, some studies have shown that eccentric exercise could be more beneficial than endurance or resistance training programs when used on elderly subjects, cardiac patients and patients with type II diabetes. However, there is a lack of research exploring the acute and chronic responses of eccentric cycling in COPD patients. Hence, to safely apply this novel modality of exercise in COPD patients, more research is warranted to assess and understand the long-term adaptations. Therefore, the proposed project aims to investigate the chronic effects of an eccentric cycling training program on metabolic disease biomarkers, muscle function, body composition, systemic inflammation and oxidative stress in patients with COPD in comparison to endurance and resistance exercise training programs. The proposed methodology to achieve these aims includes a controlled parallel trial to compare the effects of a 16-week eccentric training with two more conventional training programs (endurance and resistance) on metabolic disease biomarkers, muscle function, body composition, systemic inflammation and oxidative stress. We expect to demonstrate that COPD patients can tolerate eccentric cycling and more importantly we predict that eccentric cycling training is a more ideal training exercise for COPD patients than endurance and resistance exercises it involves less cardiopulmonary demand, but allowing patients to workout at greater intensities. This would maximize the gains in muscle mass and strength in concordance with improvements on the health related outcomes, such as systemic inflammation oxidative stress, body composition, dyslipidemia, and insulin resistance.
Health condition or problem studied
- Free text:
- CHRONIC OBSTRUCTIVE PULMONARY DISEASE
- ICD10:
- J44 - Other chronic obstructive pulmonary disease
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 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.
- Arm 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.
Endpoints
- Primary outcome:
- 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.
- Secondary outcome:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Chile
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universidad Finis Terrae Santiago
Recruitment period and number of participants
- Planned study start date:
- 2016-04-03
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 45
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Male
- Minimum Age:
- 40 Years
- Maximum Age:
- 90 Years
- Additional 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 (Gutiérrez et al., 2007; Pavié et al., 2011).
Addresses
Primary Sponsor
- Address:
- Universidad Finis TerraeDr Santiago Aranguiz1509 Pedro de Valdivia Av.7501015 SantiagoChile
- Telephone:
- (+56) 2 2420 7226
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universidad Finis TerraeDr Hermann Zbinden1509 Pedro de Valdivia7501015 SantiagoChile
- Telephone:
- +56(2)224207574
- Fax:
- +56(2)224207574
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universidad Finis TerraeDr Santiago Aranguiz1509 Pedro de Valdivia Av.7501015 SantiagoChile
- Telephone:
- (+56) 2 2420 7226
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universidad Finis TerraeDr Hermann Zbinden1509 Pedro de Valdivia7501015 SantiagoChile
- Telephone:
- +56(2)224207574
- Fax:
- +56(2)224207574
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-12-06
- Ethics committee number:
- 11150293
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-12-20
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00009711 - The trials DRKS00009711 and DRKS00009755 are part of one project
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry