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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00302068
First received: March 9, 2006
Last updated: June 1, 2015
Last verified: May 2015
Results First Received: November 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Heart Diseases
Interventions: Behavioral: Supervised Aerobic Exercise
Drug: Sertraline
Drug: Placebo Pill.

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Supervised Aerobic Exercise     Sertraline (Zoloft)     Placebo Control  
STARTED     37     40     24  
COMPLETED     36     36     23  
NOT COMPLETED     1     4     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Supervised Aerobic Exercise     Sertraline (Zoloft)     Placebo Control     Total  
Number of Participants  
[units: participants]
  37     40     24     101  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     22     24     14     60  
>=65 years     15     16     10     41  
Age  
[units: years]
Mean (Standard Deviation)
  64.7  (11.0)     63.4  (10.2)     63.5  (11.4)     63.9  (11)  
Gender  
[units: participants]
       
Female     13     15     4     32  
Male     24     25     20     69  
Region of Enrollment  
[units: participants]
       
United States     37     40     24     101  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale   [ Time Frame: Measured at 16 weeks ]

2.  Secondary:   Heart Rate Variability (HRV)   [ Time Frame: Baseline, 16 weeks ]

3.  Secondary:   Percent Change in Flow Mediated Dilation (FMD)   [ Time Frame: Baseline, 16 weeks ]

4.  Secondary:   C-reactive Protein (CRP)   [ Time Frame: Baseline, 16 weeks ]

5.  Secondary:   Platelet Factor 4   [ Time Frame: Baseline, 16 weeks ]

6.  Secondary:   Baroreflex Sensitivity (BRS)   [ Time Frame: Baseline, 16 weeks ]

7.  Secondary:   Interleuken 6 (IL-6)   [ Time Frame: Baseline, 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: blume003@mc.duke.edu


Publications:


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00302068     History of Changes
Other Study ID Numbers: Pro00011980
R01HL080664-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: March 9, 2006
Results First Received: November 1, 2012
Last Updated: June 1, 2015
Health Authority: United States: Federal Government