Trial Outcomes & Findings for Physical Training and Heart Rate Variability in COPD (NCT NCT01889563)
NCT ID: NCT01889563
Last Updated: 2014-01-10
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
baseline (before physical exercise training program), 6 and 12 weeks after intervention
Results posted on
2014-01-10
Participant Flow
Participant milestones
| Measure |
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.
|
No Physical Exercise Training Program
No Physical Exercise Training Program
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Training and Heart Rate Variability in COPD
Baseline characteristics by cohort
| Measure |
Physical Exercise Training Program
n=17 Participants
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
n=15 Participants
No Physical Exercise Training Program
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 7 • n=5 Participants
|
66 years
STANDARD_DEVIATION 10 • n=7 Participants
|
66 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (before physical exercise training program), 6 and 12 weeks after interventionPatients 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
Outcome measures
| Measure |
Physical Exercise Training Program
n=10 Participants
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
n=10 Participants
No Physical Exercise Training Program
|
|---|---|---|
|
The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.
Baseline
|
3.7 miliseconds
Standard Deviation 1.7
|
2.8 miliseconds
Standard Deviation 1.4
|
|
The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.
After 6-weeks
|
7.1 miliseconds
Standard Deviation 3.6
|
2.5 miliseconds
Standard Deviation 0.8
|
|
The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.
After 12-weeks
|
13.6 miliseconds
Standard Deviation 8.8
|
2.5 miliseconds
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training programPatients 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.
Outcome measures
| Measure |
Physical Exercise Training Program
n=10 Participants
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
n=10 Participants
No Physical Exercise Training Program
|
|---|---|---|
|
Walking Distance on Six Minute Walking Test
Baseline
|
341 meters
Standard Deviation 210
|
327 meters
Standard Deviation 157
|
|
Walking Distance on Six Minute Walking Test
After 6-weeks
|
596 meters
Standard Deviation 246
|
430 meters
Standard Deviation 159
|
|
Walking Distance on Six Minute Walking Test
After 12-weeks
|
602 meters
Standard Deviation 307
|
424 meters
Standard Deviation 173
|
Adverse Events
Physical Exercise Training Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Physical Exercise Training Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Audrey Borghi e Silva
Federal university of Sao Carlos
Phone: +55 163351-8952
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place