NCT01573728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

April 5, 2012

Last Update Submit

March 31, 2016

Conditions

Depression

Keywords

DepressionBiomarkersExercise

Outcome Measures

Primary Outcomes (1)

  • PHQ 9 depression score

    3 months

Secondary Outcomes (3)

  • Biomarkers of inflammation and neurogenesis

    3 months

  • SF-36

    3 months

  • Blood Pressure

    3 months

Study Arms (2)

Low Exercise Arm

ACTIVE COMPARATOR

Low dose exercise (50 Minutes)

Behavioral: Low dose exercise

Public Health Exercise

EXPERIMENTAL

Public Health dose exercise (150 minutes)

Behavioral: Public Health Exercise

Interventions

Low dose exerciseBEHAVIORAL

Exercise totaling 50 minutes per week and low intensity

Low Exercise Arm
Public Health ExerciseBEHAVIORAL

At least 150 minutes at moderate intensity

Public Health Exercise

Eligibility Criteria

Age46 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Daniel O Clark, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 9, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

April 1, 2016

Record last verified: 2016-03

Locations

US(1)