Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331305
Status:
COMPLETED
Last Update Posted:
2013-08-29
First Post:
2006-05-26
Brief Title:
Exercise Training Versus Drug Therapy for Treating Depression in Older Adults
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Exercise Training and Depression in Older Adults II
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of both center-based and home-based exercise versus the antidepressant drug sertraline in treating depression in middle-aged and older adults
Detailed Description:
The combination of an aging population and the increased prevalence of chronic diseases among the elderly presents a major public health concern Depression acts as both a cause and a consequence of disability and with major depressive disorder MDD affecting up to 25 of women and 12 of men during their lifetimes effective treatments for people of all ages must be made available Although antidepressant medications are available as treatments for MDD they sometimes either do not adequately relieve depressive symptoms or do relieve depressive symptoms but cause undesirable side effects These side effects may become more common or more problematic as people age Alternative approaches to treating depression therefore are necessary Research suggests that exercise positively affects the levels of certain mood-enhancing neurotransmitters in the brain This study will evaluate the effectiveness of both center-based and home-based exercise versus the antidepressant drug sertraline in treating depression in middle-aged and older adults
Participants in this double-blind study will be randomly assigned to one of the following four treatments for 16 weeks supervised aerobic exercise home-based aerobic exercise drug therapy or placebo All participants assigned to an exercise condition will report to the study site for a baseline exercise stress test Participants assigned to supervised aerobic exercise will attend study visits 3 times per week for an exercise session Each session will entail 10 minutes of warm-up exercises followed by 30 to 35 minutes of continuous walking biking or jogging and 10 to 15 minutes of cool-down exercises Participants assigned to home-based aerobic exercise will attend one introductory session with an exercise physiologist who will prescribe an exercise regimen and provide instruction on how to self-monitor pulse rate They will also receive written information about their exercise plan tips for maintaining progress and relapse prevention and daily activity logs The exercise prescription will be adjusted on a bi-weekly basis Participants will be expected to exercise 3 times per week on their own and will perform 10 minutes of warm-up exercises followed by 30 to 35 minutes of continuous walking biking or jogging and 10 to 15 minutes of cool-down exercises In addition they will mail in daily activity logs weekly for the first 6 weeks and biweekly for the remaining 10 weeks Brief telephone contacts will be made to monitor progress answer questions and provide individualized feedback Additionally the exercise physiologist will conduct home visits at Weeks 4 and 8 Participants assigned to receive sertraline or placebo will receive their medication in pill-form at baseline and Weeks 2 4 8 12 and 16 study visits All participants will receive several phone calls to assess treatment response and suicide risk These calls will take place weekly for the first 4 weeks and biweekly for the remainder of the study Follow-up visits will occur at Months 6 and 12 post-treatment and will include participating in psychological interviews and filling out questionnaires
Participants in this double-blind study will be randomly assigned to one of the following four treatments for 16 weeks supervised aerobic exercise home-based aerobic exercise drug therapy or placebo All participants assigned to an exercise condition will report to the study site for a baseline exercise stress test Participants assigned to supervised aerobic exercise will attend study visits 3 times per week for an exercise session Each session will entail 10 minutes of warm-up exercises followed by 30 to 35 minutes of continuous walking biking or jogging and 10 to 15 minutes of cool-down exercises Participants assigned to home-based aerobic exercise will attend one introductory session with an exercise physiologist who will prescribe an exercise regimen and provide instruction on how to self-monitor pulse rate They will also receive written information about their exercise plan tips for maintaining progress and relapse prevention and daily activity logs The exercise prescription will be adjusted on a bi-weekly basis Participants will be expected to exercise 3 times per week on their own and will perform 10 minutes of warm-up exercises followed by 30 to 35 minutes of continuous walking biking or jogging and 10 to 15 minutes of cool-down exercises In addition they will mail in daily activity logs weekly for the first 6 weeks and biweekly for the remaining 10 weeks Brief telephone contacts will be made to monitor progress answer questions and provide individualized feedback Additionally the exercise physiologist will conduct home visits at Weeks 4 and 8 Participants assigned to receive sertraline or placebo will receive their medication in pill-form at baseline and Weeks 2 4 8 12 and 16 study visits All participants will receive several phone calls to assess treatment response and suicide risk These calls will take place weekly for the first 4 weeks and biweekly for the remainder of the study Follow-up visits will occur at Months 6 and 12 post-treatment and will include participating in psychological interviews and filling out questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH049679 | NIH | None | None |
| DSIR GT-GS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH049679 |