Exercise in Treatment Resistant Depression (TRD): A Feasibility Study

NCT ID: NCT01383811

Last Updated: 2014-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-06-30

Brief Summary

The objective of this study is to determine the effects of adjunct exercise in treatment resistant depression. The central hypothesis for the research is that adjunct exercise with usual care in Treatment Resistant Depression (TRD) will have significant effects in improving the psychiatric symptoms in comparison to usual care alone.

Detailed Description

Participants with treatment resistant depression will be recruited to participate in a 12-week clinical trial on the effects of adjunct moderate-intensity exercise versus usual care. Primary outcome measure will be reduction in baseline scores on Hamilton Depression Rating Scale (17 item). Secondary outcome measure will include reduction in baseline scores of clinical global impression severity, pittsburgh sleep quality index global score, scores on beck depression inventory, and improvement in actigraphic sleep.

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate Intensity Aerobic Exercise

Group Type: ACTIVE_COMPARATOR

Moderate Intensity Aerobic Exercise

Intervention Type: OTHER

Individuals in this group will receive moderate intensity exercise in addition to their usual care (Medications+/-Psychotherapy). The moderate intensity exercise program will involve gradual progression in exercise intensity and duration. During the first 4 weeks, participants will attend 3 supervised sessions/week and will be asked to complete at least 2 unsupervised aerobic exercise sessions/week. From weeks 5-8 the number of supervised sessions will be 2/week with at least 3 unsupervised aerobic exercise sessions/week. From weeks 9-12, the participants will have only 1 supervised session/week and will be asked to complete at least 4 unsupervised aerobic exercise sessions/week. In total, the participants will be required to complete 150 minutes of moderate physical activity/week.

Wait-list

Intervention Type: OTHER

The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.

Wait List/Usual Care

The subjects in this group will continue to receive the usual treatment that they were on at the time of enrollment through the wait list period of 12 weeks. Subsequently they will receive the 12 weeks of aerobic exercise program intervention

Group Type: OTHER

Wait-list

Intervention Type: OTHER

The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.

Interventions

Moderate Intensity Aerobic Exercise

Individuals in this group will receive moderate intensity exercise in addition to their usual care (Medications+/-Psychotherapy). The moderate intensity exercise program will involve gradual progression in exercise intensity and duration. During the first 4 weeks, participants will attend 3 supervised sessions/week and will be asked to complete at least 2 unsupervised aerobic exercise sessions/week. From weeks 5-8 the number of supervised sessions will be 2/week with at least 3 unsupervised aerobic exercise sessions/week. From weeks 9-12, the participants will have only 1 supervised session/week and will be asked to complete at least 4 unsupervised aerobic exercise sessions/week. In total, the participants will be required to complete 150 minutes of moderate physical activity/week.

Intervention Type: OTHER

Wait-list

The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.

Intervention Type: OTHER

Other Intervention Names

Exercise; Aerobic Exercise; Usual care; Care as usual; Standard Care

Eligibility Criteria

Inclusion Criteria

• Being sedentary (exercising less than 3 times/week for > 20 minutes at moderate/vigorous intensity for each bout)
• Ability to come for supervised exercises up to 5 days/week.
• On stable doses of medication or psychotherapy (within last 1 month) for underlying depression and willingness to continue on stable dose or therapy schedule during active phase of study participation, with the exception of during acute exacerbation of symptoms of psychiatric illness.
• Being able to read, understand, and provide written informed consent.

Exclusion Criteria

• DSM-IV TR Axis I diagnosis of bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance or alcohol abuse/dependence disorder (except nicotine dependence) in the past 12 months. Patients with current primary anxiety disorder will also be excluded.
• Behavioral or personality disturbances, which may significantly interfere with study participation.
• Evidence of acute suicidal risk.
• Medical contraindication for physical exercise (significant orthopedic or cardiopulmonary disorder) that would prevent regular aerobic exercise. The American College of Sports Medicine criteria for risk stratification will be used and where indicated medical clearance for exercise will be obtained through the subject's primary care physician.
• Pregnancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ravi Singareddy

Associate Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ravi Singareddy, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Univ. College of Medicine

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

34749EP

Identifier Type: -

Identifier Source: org_study_id