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Physical Training and Heart Rate Variability in COPD

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ClinicalTrials.gov Identifier: NCT01889563
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Renata Goncalves Mendes, Universidade Federal de Sao Carlos

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Other: Physical Exercise Training Program Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Potential Effects of 6 vs 12-weeks of Physical Training on Cardiac Autonomic Function and Functional Capacity in COPD
Study Start Date : May 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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.
Other: Physical 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.

No Intervention: No Physical Exercise Training Program
No Physical Exercise Training Program



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889563


Locations
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Brazil
Federal university f Sao Carlos
Sao Carlos, Sao Paulo, Brazil, 13565-905
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
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Principal Investigator: Audrey Borghi-Silva, PhD Universidade Federal de Sao Carlos
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Responsible Party: Renata Goncalves Mendes, PhD, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01889563    
Other Study ID Numbers: COPD6VS12
First Posted: June 28, 2013    Key Record Dates
Results First Posted: January 10, 2014
Last Update Posted: January 10, 2014
Last Verified: November 2013
Keywords provided by Renata Goncalves Mendes, Universidade Federal de Sao Carlos:
chronic obstructive pulmonary disease
heart rate variability
physical training
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases