Role of Exercise in Depression in Middle Aged and Older Adults (RED)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01573728
First received: April 5, 2012
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Depression
Behavioral: Low dose exercise
Behavioral: Public Health Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Exercise in Depression Among Middle Aged and Older Adults

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • PHQ 9 depression score [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarkers of inflammation and neurogenesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Exercise Arm
Low dose exercise (50 Minutes)
Behavioral: Low dose exercise
Exercise totaling 50 minutes per week and low intensity
Experimental: Public Health Exercise
Public Health dose exercise (150 minutes)
Behavioral: Public Health Exercise
At least 150 minutes at moderate intensity

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.

  Eligibility

Ages Eligible for Study:   46 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

46 or older English speaking Community dwelling Access to a private room Access to a telephone Permanent address Willingness to be randomized Internet-enabled computer in home or willingness to have such installed Score of 10 or more on PHQ-9 Major depressive disorder as indicated by the Structured Clinical Interview for DSM-IV (SCID) Primary care provider approval for participation in moderate-intensity exercise

Exclusion Criteria:

Any serious medical condition for which exercise is contraindicated by the ACSM Current diagnosis of one of the following: psychosis, bipolar disorder, lupus, HIV, AIDS, IBS, Crones, Rheumatoid Arthritis or related conditions, cancer or treatment for cancer within the last year. Acute illness Terminal illness (not expected to live beyond one year) Unwillingness to provide informed consent Unwillingness to donate blood Receiving disability insurance Currently engaged in professional psychotherapy Currently engaged in regular exercise Pregnant or nursing in the past 6 months, or plans to become so within 12 months Enrolled in another study Member of household enrolled in the same study Residence outside of Marion County Residence relocation plans within 12 months Substance abuse Suicide ideation as indicated by the PHQ-9

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573728

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Daniel O Clark, PhD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01573728     History of Changes
Other Study ID Numbers: 1111007450, R24MH080827
Study First Received: April 5, 2012
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Depression
Biomarkers
Exercise

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014