ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise to Treat Depression in Individuals With Coronary Heart Disease (UPBEAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00302068
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : January 24, 2013
Last Update Posted : June 29, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Heart Diseases
Interventions Behavioral: Supervised Aerobic Exercise
Drug: Sertraline
Drug: Placebo Pill.
Enrollment 101
Recruitment Details Enrollment began in June 2006 and ended in September 2010. Participants were recruited from physician referrals, community-based screenings, and mass media advertisements.
Pre-assignment Details  
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 37 40 24
Completed 36 36 23
Not Completed 1 4 1
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 37 40 24 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 24 participants 101 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  59.5%
24
  60.0%
14
  58.3%
60
  59.4%
>=65 years
15
  40.5%
16
  40.0%
10
  41.7%
41
  40.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 40 participants 24 participants 101 participants
64.7  (11.0) 63.4  (10.2) 63.5  (11.4) 63.9  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 24 participants 101 participants
Female
13
  35.1%
15
  37.5%
4
  16.7%
32
  31.7%
Male
24
  64.9%
25
  62.5%
20
  83.3%
69
  68.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 40 participants 24 participants 101 participants
37 40 24 101
1.Primary Outcome
Title Hamilton Depression Rating Scale
Hide Description 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.
Time Frame Measured at 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 36 37 23
Mean (95% Confidence Interval)
Unit of Measure: Raw changes in Ham-D scores
-7.5
(-9.8 to -5.0)
-6.1
(-8.4 to -3.9)
-4.5
(-7.6 to -1.5)
2.Secondary Outcome
Title Heart Rate Variability (HRV)
Hide Description 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)
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis based on 93 participants with valid baseline measurements.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 33 38 22
Mean (Standard Deviation)
Unit of Measure: millisecond
Baseline 116  (36) 120  (39) 123  (24)
16 Weeks 122  (35) 118  (39) 112  (23)
3.Secondary Outcome
Title Percent Change in Flow Mediated Dilation (FMD)
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 36 37 23
Measure Type: Number
Unit of Measure: percentage change
0.2 0.9 0
4.Secondary Outcome
Title C-reactive Protein (CRP)
Hide Description [Not Specified]
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 36 37 23
Mean (Standard Deviation)
Unit of Measure: ug/ml
Baseline 2.5  (34) 2.5  (38) 2.4  (23)
16 Week 2.1  (34) 2.5  (38) 2.5  (23)
5.Secondary Outcome
Title Platelet Factor 4
Hide Description [Not Specified]
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 36 37 23
Mean (Standard Deviation)
Unit of Measure: IU/ml
Baseline 44.1  (36) 34.1  (38) 32.0  (23)
16 Week 35.5  (36) 34.0  (38) 34.4  (23)
6.Secondary Outcome
Title Baroreflex Sensitivity (BRS)
Hide Description [Not Specified]
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis based on 92 participants with valid baseline measurement.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 32 38 22
Mean (Standard Deviation)
Unit of Measure: msec/mmHg
Baseline 4.8  (32) 4.7  (35) 4.9  (23)
Week 16 4.0  (30) 5.1  (33) 4.1  (21)
7.Secondary Outcome
Title Interleuken 6 (IL-6)
Hide Description [Not Specified]
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 36 37 23
Mean (Standard Deviation)
Unit of Measure: pg/ml
Baseline 1.98  (34) 1.7  (38) 1.95  (23)
16 Week 1.80  (34) 2.1  (38) 1.85  (23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/40 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/40 (0.00%)   0/24 (0.00%) 
Relatively small sample size. Participants had to be willing to accept the condition to which they were randomly assigned, and patients who were not interested in exercise or taking an antidepressant were unlikely to have volunteered.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. James Blumenthal
Organization: DukeUMC
Phone: 919-684-3969
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00302068     History of Changes
Other Study ID Numbers: Pro00011980
R01HL080664-01A1 ( U.S. NIH Grant/Contract )
First Submitted: March 9, 2006
First Posted: March 13, 2006
Results First Submitted: November 1, 2012
Results First Posted: January 24, 2013
Last Update Posted: June 29, 2015