- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889563
Physical Training and Heart Rate Variability in COPD
Potential Effects of 6 vs 12-weeks of Physical Training on Cardiac Autonomic Function and Functional Capacity in COPD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sao Paulo
-
Sao Carlos, Sao Paulo, Brazil, 13565-905
- Federal university f Sao Carlos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a diagnosis of COPD according to criteria set forth by the Global Initiative for Chronic Obstructive Lung Disease (19),
- compliance with medical management,
- no change in medical management and no decompensation episodes for at least one month prior to study initiation, and
- no participation in a regular physical exercise program for at least six months prior to study initiation.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical exercise training program
Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets.
Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate.
The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session.
All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
|
Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets.
Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate.
The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session.
All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
|
No Intervention: No Physical Exercise Training Program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.
Time Frame: baseline (before physical exercise training program), 6 and 12 weeks after intervention
|
Patients underwent the assessments proposed in the study on an outpatient basis before and after 6 and 12 weeks of physical exercise training program.
The primary end-point measure was the SD1, a nonlinear index of HRV that represent the parasympathetic modulation
|
baseline (before physical exercise training program), 6 and 12 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking Distance on Six Minute Walking Test
Time Frame: Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program
|
Patients underwent the assessments proposed in the study on an outpatient basis before physical exercise training program and after 6 and 12 weeks of physical exercise training program.
The second end-point was walking distance on six minute walking test.
|
Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program
|
Collaborators and Investigators
Investigators
- Principal Investigator: Audrey Borghi-Silva, PhD, Universidade Federal de Sao Carlos
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPD6VS12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease (COPD)
-
University College, LondonUniversity of Cambridge; National Institute for Health Research, United Kingdom and other collaboratorsUnknownChronic Obstructive Pulmonary Disease (COPD).United Kingdom
-
Reham Mohammed ElmorshedyCompletedChronic Obstructive Pulmonary Disease(COPD)Egypt
-
AstraZenecaCompletedChronic Obstructive Pulmonary Disease (COPD).United Kingdom
-
Virginia Commonwealth UniversityFisher and Paykel HealthcareCompletedChronic Obstructive Pulmonary Disease(COPD)United States
-
Beaumont HospitalAerogenCompletedChronic Obstructive Pulmonary Disease | COPD | COPD Exacerbation | Copd Exacerbation AcuteIreland
-
Medtronic BRCUnknownCOPD | COPD Exacerbation
-
Chiesi Farmaceutici S.p.A.CompletedModerate to Severe Chronic Obstructive Pulmonary Disease (COPD)Bulgaria, Germany, Hungary, Poland, Russian Federation, United Kingdom
-
Chiesi Farmaceutici S.p.A.CompletedChronic Obstructive Pulmonary Disease (COPD) | COPDUnited Kingdom
-
Elpen Pharmaceutical Co. Inc.Completed
Clinical Trials on Physical Exercise Training Program Exercise
-
Cairo UniversityRecruiting
-
Cairo UniversityRecruiting
-
Lars Bo AndersenUnknownEpilepsy | Seizure Disorder | Epileptic Seizures | EpilepsiaDenmark
-
University of ArizonaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedOsteoarthritisUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...RecruitingEpilepsy in ChildrenSpain
-
Philip Morris Products S.A.CompletedSmoking | Exercise CapacityGermany
-
The Hong Kong Polytechnic UniversityUniversity of Santo TomasUnknownMild Cognitive ImpairmentPhilippines
-
Paracelsus Medical UniversityCompletedChronic Obstructive Pulmonary DiseaseAustria
-
Instituto Materno Infantil Prof. Fernando FigueiraCompleted
-
University of Alabama at BirminghamPulmonary Fibrosis FoundationCompletedIdiopathic Pulmonary FibrosisUnited States