Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Potential Effects of 6 vs 12-weeks of Physical Training on Cardiac Autonomic Function and Functional Capacity in COPD
To contrast the potential effects of physical exercise training program (PTP) of a 6 versus 12 weeks on cardiac autonomic modulation by linear and non-linear heart rate variability (HRV) indices and functional capacity in moderate-to-severe COPD patients.
This is a prospective randomized controled trial. A total of fifty two patients were
recruited, however, only 32 patients met all inclusion criteria. Patients that were included
presented: 1) a diagnosis of COPD according to criteria set forth by the Global Initiative
for Chronic Obstructive Lung Disease (19), 2) compliance with medical management, 3) no
change in medical management and no decompensation episodes for at least one month prior to
study initiation, and 4) no participation in a regular physical exercise program for at
least six months prior to study initiation. Exclusion criteria consisted of the presence of
orthopedic or neurological conditions that would preclude participation in a physical
exercise program, a history of cardiac arrhythmias, a past history consistent with heart
disease, diabetes mellitus, arterial hypertension and failure to comply with the research
protocol.
Patients were randomly assigned to physical exercise training program PTG, (n=17) or to a
control group (CG, n=15) without aerobic exercise training by drawing of shuffled, opaque,
coded envelopes that were opened immediately before starting each case. However, after the
randomization process, five patients refused to continue and seven interested patients were
excluded.
Finally the groups were composed of PTG (n=10) and control group (CG, n=10). Heart rate
variability (HRV) on rest and during submaximal test was determined by linear analysis
(rMSSD and SDNN) and nonlinear indices SD1, SD2 and sample entropy (SE). In addition, the
physiological responses were obtained during cardiopulmonary exercise testing (CPX), the
walking distance (WD) on six minute walking test and submaximal constant speed testing
(CST). PTP consisted of 30 minutes of aerobic exercise training on a treadmill, 3 times per
week at 70% of CPX peak speed rate. Patients were evaluated on baseline, 6 and 12 weeks.
All patients received regular treatment consisting of inhaled bronchodilators and steroids
and the dosage did not changed during the study. The study protocol was approved by the
Institutional Ethics Committee and all patients signed a written consent form prior to study
initiation (109/2006). The target number of patients was calculated to be 10 patients in
each group, based on a 5% type I error, a 2-sided test, and an 80% power to detect a change
between the groups in 5 to SD2 at rest. Considering a drop out of 20%, 12 patients in each
group were calculated. Due to the Gaussian distribution and/or homogeneity of variance in
variable values, parametric tests were selected for statistical analysis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03282019 -
Study of Long-term HFNC for COPD Patients With HOT
|
N/A | |
Completed |
NCT05573464 -
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
|
Phase 3 | |
Recruiting |
NCT06040086 -
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
|
Phase 3 | |
Not yet recruiting |
NCT06376994 -
Multi-Center Clean Air Randomized Controlled Trial in COPD
|
Phase 3 | |
Completed |
NCT02728674 -
Management of Patients With Respiratory Symptoms in Sweden
|
N/A | |
Completed |
NCT02797392 -
Feasibility of a Preventive Program Against Lifestyle Related Diseases
|
N/A | |
Completed |
NCT02926534 -
Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan
|
N/A | |
Recruiting |
NCT02415478 -
Bronchioscopic Lung Volume Reduction (BLVR)
|
N/A | |
Completed |
NCT02512510 -
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03487406 -
Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2)
|
Phase 2 | |
Completed |
NCT02518139 -
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT02774226 -
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02459080 -
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01893476 -
A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management
|
N/A | |
Withdrawn |
NCT01908933 -
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
|
Phase 3 | |
Completed |
NCT01908140 -
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
Completed |
NCT01701869 -
Microbiology & Immunology of the Chronically-inflamed Airway
|
N/A | |
Recruiting |
NCT02527486 -
Seoul National University Airway Registry
|
N/A | |
Terminated |
NCT01388920 -
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
|
Phase 2 |