Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT01573728
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2012-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Exercise in Depression in Middle Aged and Older Adults
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Role of Exercise in Depression Among Middle Aged and Older Adults
Status:
COMPLETED
Status Verified Date:
2016-03
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:
RED
Brief Summary:
The pilot project proposed here will establish the feasibility and preliminary data necessary to test in a subsequent randomized trial: 1) whether independent of social contact, aerobic exercise training is effective in the treatment of depression and 2) whether changes in biological markers indicate an anti-inflammatory process, neurogenesis process, or both as a result of exercise. Target participants are adults aged 46 years or over who have current minor to moderate depressive symptoms.
This pilot is a three-arm design of low dose exercise versus public health dose exercise intended to: 1) establish the feasibility, acceptance, and safety of Internet-based supervised exercise training and 2) obtain retention and attendance estimates needed to determine sample sizes for the follow-up trial.
This pilot is a three-arm design of low dose exercise versus public health dose exercise intended to: 1) establish the feasibility, acceptance, and safety of Internet-based supervised exercise training and 2) obtain retention and attendance estimates needed to determine sample sizes for the follow-up trial.
Detailed Description:
Recruitment will occur by phone or in the clinic by the Practice Based Research Network (PBRN) using the attached screener. Prior to contact, patients will have been identified as potentially eligible by having had a current or past diagnosis of depression as indicated in the Regenstrief Medical Records System. These potentially eligible persons must then be approved for the study and moderate-intensity exercise by their primary care provider before the recruitment call and screener from the PBRN. The telephone screener uses the PHQ 9 (Patient Health Questionnaire-9) and a modified Stanford Brief Physical Activity Scale. Those with a PHQ-9 score of 10 or greater and who indicate no current regular physical activity will be eligible for further screening.
Following recruitment by the PBRN, study personnel will call and confirm the PHQ-9 results with the SCID. If the patient passes the follow-up screening, the staff will arrange to travel to the patient's home. Study staff will obtain informed consent and perform baseline assessments including the Short Form-36, PHQ-9, Generalized Anxiety Disorder-7 (GAD-7), Medical Outcomes Study Social Support survey, and the ASA 24. The ASA 24 is an online dietary screener that measures energy intake over a 24 hour period. It is posted on the National Cancer Institute's website. Medication adherence and smoking levels will be measured by self report. Height, weight, waist circumference, and blood pressure will also be measured. With the exception of the SCID, each of these measures will be repeated at 3 month follow-up. The PHQ-9 will be completed monthly. Also, each month (three different time periods) participants will be asked to wear an armband accelerometer to measure energy expenditure over a 2 week period. The protocol gives details of the accelerometry procedures.
Blood will be drawn using a 2 ten ml tubes at base line and 3 month follow-up using procedures described in the Data Safety and Monitoring Plan. We will ask that the participants fast for eight hours prior to the blood draw, but will note if that was not possible. Appointments for the blood draw will be made within five days of the assessment and also take place within the participant's home.. The blood samples will measure circulating levels of the proinflammatory cytokines IL-1α, IL-1β, IL-6, and TNF-α; the anti-inflammatory cytokines IL-1ra and IL-10; the acute-phase reactant CRP; and VEGF and BDNF.
Participants will be randomized to public health or low dose exercise. Randomization will be stratified by baseline use/no use of prescription anti-depressants. Both low and public health exercise arms will receive supervised one on one instruction via video conference. The exercise will occur five times a week for 10 to 30 minutes each session. During the twelve week intervention, the exercise will increase in intensity and may include wrist and ankle weights. During each session, the participant will rate their perceived exertion using the Borg's Rating of Perceived Physical Exertion (RPE): a 10 Point Scale where 0 is no movement and 10 is maximum effort. Participants will also wear a heart rate monitor. Participants in the low dose exercise arm will be instructed to exercise at an RPE of less than 5 and a heart rate of less than 50% of their age-adjusted maximum (200 minus participant's age). The participants in the public health dose arm will be instructed to exercise at an RPE of between 5 and 7 and to maintain a heart rate of 55 to 70% of age-adjusted maximum heart rate.
All assessments and blood draws will occur in the participant's home.
Following recruitment by the PBRN, study personnel will call and confirm the PHQ-9 results with the SCID. If the patient passes the follow-up screening, the staff will arrange to travel to the patient's home. Study staff will obtain informed consent and perform baseline assessments including the Short Form-36, PHQ-9, Generalized Anxiety Disorder-7 (GAD-7), Medical Outcomes Study Social Support survey, and the ASA 24. The ASA 24 is an online dietary screener that measures energy intake over a 24 hour period. It is posted on the National Cancer Institute's website. Medication adherence and smoking levels will be measured by self report. Height, weight, waist circumference, and blood pressure will also be measured. With the exception of the SCID, each of these measures will be repeated at 3 month follow-up. The PHQ-9 will be completed monthly. Also, each month (three different time periods) participants will be asked to wear an armband accelerometer to measure energy expenditure over a 2 week period. The protocol gives details of the accelerometry procedures.
Blood will be drawn using a 2 ten ml tubes at base line and 3 month follow-up using procedures described in the Data Safety and Monitoring Plan. We will ask that the participants fast for eight hours prior to the blood draw, but will note if that was not possible. Appointments for the blood draw will be made within five days of the assessment and also take place within the participant's home.. The blood samples will measure circulating levels of the proinflammatory cytokines IL-1α, IL-1β, IL-6, and TNF-α; the anti-inflammatory cytokines IL-1ra and IL-10; the acute-phase reactant CRP; and VEGF and BDNF.
Participants will be randomized to public health or low dose exercise. Randomization will be stratified by baseline use/no use of prescription anti-depressants. Both low and public health exercise arms will receive supervised one on one instruction via video conference. The exercise will occur five times a week for 10 to 30 minutes each session. During the twelve week intervention, the exercise will increase in intensity and may include wrist and ankle weights. During each session, the participant will rate their perceived exertion using the Borg's Rating of Perceived Physical Exertion (RPE): a 10 Point Scale where 0 is no movement and 10 is maximum effort. Participants will also wear a heart rate monitor. Participants in the low dose exercise arm will be instructed to exercise at an RPE of less than 5 and a heart rate of less than 50% of their age-adjusted maximum (200 minus participant's age). The participants in the public health dose arm will be instructed to exercise at an RPE of between 5 and 7 and to maintain a heart rate of 55 to 70% of age-adjusted maximum heart rate.
All assessments and blood draws will occur in the participant's home.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R24MH080827 | NIH | None | https://reporter.nih.gov/quic… | View |