Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
chronic obstructive pulmonary disease, heart rate variability, physical training
Brief summary
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.
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.
Interventions
OTHERPhysical Exercise Training Program Exercise
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.
Sponsors
Universidade Federal de Sao Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
1. presence of orthopedic or neurological conditions that would preclude participation in a physical exercise program, 2. a history of cardiac arrhythmias, 3. a past history consistent with heart disease, diabetes mellitus, arterial hypertension and failure to comply with the research protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking Distance on Six Minute Walking Test | 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. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| No Physical Exercise Training Program No Physical Exercise Training Program | 15 |
| Total | 32 |
Baseline characteristics
| Characteristic | No Physical Exercise Training Program | Physical Exercise Training Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 7 | 66 years STANDARD_DEVIATION 8 |
| Region of Enrollment Brazil | 15 participants | 17 participants | 32 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 15 |
| serious Total, serious adverse events | 0 / 17 | 0 / 15 |
Outcome results
Primary
The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.
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
Time frame: baseline (before physical exercise training program), 6 and 12 weeks after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Exercise Training Program | The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity. | Baseline | 3.7 miliseconds | Standard Deviation 1.7 |
| Physical Exercise Training Program | The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity. | After 6-weeks | 7.1 miliseconds | Standard Deviation 3.6 |
| Physical Exercise Training Program | The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity. | After 12-weeks | 13.6 miliseconds | Standard Deviation 8.8 |
| No Physical Exercise Training Program | The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity. | Baseline | 2.8 miliseconds | Standard Deviation 1.4 |
| No Physical Exercise Training Program | The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity. | After 6-weeks | 2.5 miliseconds | Standard Deviation 0.8 |
| No Physical Exercise Training Program | The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity. | After 12-weeks | 2.5 miliseconds | Standard Deviation 1.3 |
Secondary
Walking Distance on Six Minute Walking Test
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.
Time frame: Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Exercise Training Program | Walking Distance on Six Minute Walking Test | Baseline | 341 meters | Standard Deviation 210 |
| Physical Exercise Training Program | Walking Distance on Six Minute Walking Test | After 6-weeks | 596 meters | Standard Deviation 246 |
| Physical Exercise Training Program | Walking Distance on Six Minute Walking Test | After 12-weeks | 602 meters | Standard Deviation 307 |
| No Physical Exercise Training Program | Walking Distance on Six Minute Walking Test | Baseline | 327 meters | Standard Deviation 157 |
| No Physical Exercise Training Program | Walking Distance on Six Minute Walking Test | After 6-weeks | 430 meters | Standard Deviation 159 |
| No Physical Exercise Training Program | Walking Distance on Six Minute Walking Test | After 12-weeks | 424 meters | Standard Deviation 173 |