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
Verified date | November 2013 |
Source | Universidade Federal de Sao Carlos |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | June 2013 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Brazil | Federal university f Sao Carlos | Sao Carlos | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal de Sao Carlos |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | baseline (before physical exercise training program), 6 and 12 weeks after intervention | Yes |
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. | Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program | No |
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