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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Chronic Obstructive Pulmonary Disease (COPD)
Intervention Other: Physical Exercise Training Program Exercise
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Physical Exercise Training Program No Physical Exercise Training Program
Hide Arm/Group 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
Period Title: Overall Study
Started 17 15
Completed 10 10
Not Completed 7 5
Arm/Group Title Physical Exercise Training Program No Physical Exercise Training Program Total
Hide Arm/Group 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 Total of all reporting groups
Overall Number of Baseline Participants 17 15 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  70.6%
10
  66.7%
22
  68.8%
>=65 years
5
  29.4%
5
  33.3%
10
  31.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 15 participants 32 participants
67  (7) 66  (10) 66  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 32 participants
Female
3
  17.6%
5
  33.3%
8
  25.0%
Male
14
  82.4%
10
  66.7%
24
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 17 participants 15 participants 32 participants
17 15 32
1.Primary Outcome
Title The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physical Exercise Training Program No Physical Exercise Training Program
Hide Arm/Group 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
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: miliseconds
Baseline 3.7  (1.7) 2.8  (1.4)
After 6-weeks 7.1  (3.6) 2.5  (0.8)
After 12-weeks 13.6  (8.8) 2.5  (1.3)
2.Secondary Outcome
Title Walking Distance on Six Minute Walking Test
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physical Exercise Training Program No Physical Exercise Training Program
Hide Arm/Group 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
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: meters
Baseline 341  (210) 327  (157)
After 6-weeks 596  (246) 430  (159)
After 12-weeks 602  (307) 424  (173)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Physical Exercise Training Program No Physical Exercise Training Program
Hide Arm/Group 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
All-Cause Mortality
Physical Exercise Training Program No Physical Exercise Training Program
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Physical Exercise Training Program No Physical Exercise Training Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Physical Exercise Training Program No Physical Exercise Training Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Audrey Borghi e Silva
Organization: Federal university of Sao Carlos
Phone: +55 163351-8952
EMail: audrey@ufscar.br
Layout table for additonal information
Responsible Party: Renata Goncalves Mendes, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01889563    
Other Study ID Numbers: COPD6VS12
First Submitted: June 25, 2013
First Posted: June 28, 2013
Results First Submitted: June 28, 2013
Results First Posted: January 10, 2014
Last Update Posted: January 10, 2014