Trial Outcomes & Findings for Exercise to Treat Depression in Individuals With Coronary Heart Disease (NCT NCT00302068)
NCT ID: NCT00302068
Last Updated: 2015-06-29
Results Overview
The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Measured at 16 weeks
Results posted on
2015-06-29
Participant Flow
Enrollment began in June 2006 and ended in September 2010. Participants were recruited from physician referrals, community-based screenings, and mass media advertisements.
Participant milestones
| Measure |
Supervised Aerobic Exercise
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
40
|
24
|
|
Overall Study
COMPLETED
|
36
|
36
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise to Treat Depression in Individuals With Coronary Heart Disease
Baseline characteristics by cohort
| Measure |
Supervised Aerobic Exercise
n=37 Participants
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
n=40 Participants
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
n=24 Participants
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Total
n=101 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
40 participants
n=7 Participants
|
24 participants
n=5 Participants
|
101 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at 16 weeksPopulation: All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.
Outcome measures
| Measure |
Supervised Aerobic Exercise
n=36 Participants
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
n=37 Participants
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
n=23 Participants
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
|---|---|---|---|
|
Hamilton Depression Rating Scale
|
-7.5 Raw changes in Ham-D scores
Interval -9.8 to -5.0
|
-6.1 Raw changes in Ham-D scores
Interval -8.4 to -3.9
|
-4.5 Raw changes in Ham-D scores
Interval -7.6 to -1.5
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Analysis based on 93 participants with valid baseline measurements.
HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R-R intervals (SDNN)
Outcome measures
| Measure |
Supervised Aerobic Exercise
n=33 Participants
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
n=38 Participants
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
n=22 Participants
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
|---|---|---|---|
|
Heart Rate Variability (HRV)
Baseline
|
116 millisecond
Standard Deviation 36
|
120 millisecond
Standard Deviation 39
|
123 millisecond
Standard Deviation 24
|
|
Heart Rate Variability (HRV)
16 Weeks
|
122 millisecond
Standard Deviation 35
|
118 millisecond
Standard Deviation 39
|
112 millisecond
Standard Deviation 23
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (\~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.
Outcome measures
| Measure |
Supervised Aerobic Exercise
n=36 Participants
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
n=37 Participants
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
n=23 Participants
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
|---|---|---|---|
|
Percent Change in Flow Mediated Dilation (FMD)
|
0.2 percentage change
|
0.9 percentage change
|
0 percentage change
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Outcome measures
| Measure |
Supervised Aerobic Exercise
n=36 Participants
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
n=37 Participants
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
n=23 Participants
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
|---|---|---|---|
|
C-reactive Protein (CRP)
Baseline
|
2.5 ug/ml
Standard Deviation 34
|
2.5 ug/ml
Standard Deviation 38
|
2.4 ug/ml
Standard Deviation 23
|
|
C-reactive Protein (CRP)
16 Week
|
2.1 ug/ml
Standard Deviation 34
|
2.5 ug/ml
Standard Deviation 38
|
2.5 ug/ml
Standard Deviation 23
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Outcome measures
| Measure |
Supervised Aerobic Exercise
n=36 Participants
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
n=37 Participants
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
n=23 Participants
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
|---|---|---|---|
|
Platelet Factor 4
Baseline
|
44.1 IU/ml
Standard Deviation 36
|
34.1 IU/ml
Standard Deviation 38
|
32.0 IU/ml
Standard Deviation 23
|
|
Platelet Factor 4
16 Week
|
35.5 IU/ml
Standard Deviation 36
|
34.0 IU/ml
Standard Deviation 38
|
34.4 IU/ml
Standard Deviation 23
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Analysis based on 92 participants with valid baseline measurement.
Outcome measures
| Measure |
Supervised Aerobic Exercise
n=32 Participants
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
n=38 Participants
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
n=22 Participants
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
|---|---|---|---|
|
Baroreflex Sensitivity (BRS)
Baseline
|
4.8 msec/mmHg
Standard Deviation 32
|
4.7 msec/mmHg
Standard Deviation 35
|
4.9 msec/mmHg
Standard Deviation 23
|
|
Baroreflex Sensitivity (BRS)
Week 16
|
4.0 msec/mmHg
Standard Deviation 30
|
5.1 msec/mmHg
Standard Deviation 33
|
4.1 msec/mmHg
Standard Deviation 21
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Outcome measures
| Measure |
Supervised Aerobic Exercise
n=36 Participants
Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
|
Sertraline (Zoloft)
n=37 Participants
Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
Placebo Control
n=23 Participants
Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
|
|---|---|---|---|
|
Interleuken 6 (IL-6)
Baseline
|
1.98 pg/ml
Standard Deviation 34
|
1.7 pg/ml
Standard Deviation 38
|
1.95 pg/ml
Standard Deviation 23
|
|
Interleuken 6 (IL-6)
16 Week
|
1.80 pg/ml
Standard Deviation 34
|
2.1 pg/ml
Standard Deviation 38
|
1.85 pg/ml
Standard Deviation 23
|
Adverse Events
Supervised Aerobic Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sertraline (Zoloft)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place