search
Back to results

Physical Training and Heart Rate Variability in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical Exercise Training Program Exercise
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring chronic obstructive pulmonary disease, heart rate variability, physical training

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal university f Sao Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical exercise training program

No Physical Exercise Training Program

Arm Description

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 Physical Exercise Training Program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 25, 2013
Last Updated
November 21, 2013
Sponsor
Universidade Federal de Sao Carlos
search

1. Study Identification

Unique Protocol Identification Number
NCT01889563
Brief Title
Physical Training and Heart Rate Variability in COPD
Official Title
Potential Effects of 6 vs 12-weeks of Physical Training on Cardiac Autonomic Function and Functional Capacity in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
chronic obstructive pulmonary disease, heart rate variability, physical training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise training program
Arm Type
Experimental
Arm Description
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.
Arm Title
No Physical Exercise Training Program
Arm Type
No Intervention
Arm Description
No Physical Exercise Training Program
Intervention Type
Other
Intervention Name(s)
Physical Exercise Training Program Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.
Description
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
Secondary Outcome Measure Information:
Title
Walking Distance on Six Minute Walking Test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Borghi-Silva, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal university f Sao Carlos
City
Sao Carlos
State/Province
Sao Paulo
ZIP/Postal Code
13565-905
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Physical Training and Heart Rate Variability in COPD

We'll reach out to this number within 24 hrs