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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

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 28, 2013
Results First Submitted Date  ICMJE June 28, 2013
Results First Posted Date  ICMJE January 10, 2014
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
The SD1 index, a nonlinear index of heart rate variability (HRV). [ Time Frame: baseline, 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 change of SD1, a nonlinear index of HRV that represent the parasympathetic modulation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Walking Distance on Six Minute Walking Test [ Time Frame: Before and after 6 and 12 weeks of physical exercise training program ]
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 second end-point was walking distance on six minute walking test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Training and Heart Rate Variability in COPD
Official Title  ICMJE Potential Effects of 6 vs 12-weeks of Physical Training on Cardiac Autonomic Function and Functional Capacity in COPD
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Physical Exercise Training Program Exercise
  • No Intervention: No Physical Exercise Training Program
    No Physical Exercise Training Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
32
Original Actual Enrollment  ICMJE
 (submitted: June 27, 2013)
20
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889563
Other Study ID Numbers  ICMJE COPD6VS12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Renata Goncalves Mendes, Universidade Federal de Sao Carlos
Study Sponsor  ICMJE Universidade Federal de Sao Carlos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Audrey Borghi-Silva, PhD Universidade Federal de Sao Carlos
PRS Account Universidade Federal de Sao Carlos
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP