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Effects of Motivating People With Schizophrenia to Exercise

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ClinicalTrials.gov Identifier: NCT00559572
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : January 16, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the impact of motivational guidance to exercise on people with schizophrenia, based on their participation in a walking program.

Condition or disease Intervention/treatment
Schizophrenia Behavioral: Motivational group sessions Other: Time and attention control group sessions

Detailed Description:

Schizophrenia is a chronic brain disorder that affects about 1% of Americans. People with schizophrenia experience extreme paranoia, often claiming that they hear voices not heard by others and that others are invading or controlling their minds with the intent to hurt them. More specific symptoms include hallucinations, delusional behaviors, disordered movements, and decreased ability to comprehend and apply information to everyday activities. The severity of these symptoms makes self-care and regular exercise difficult for people with schizophrenia. The fatality rate from diabetes, heart disease, and other obesity-related illnesses is significantly higher in people with schizophrenia. Exercise is known to reduce health problems associated with obesity, yet few studies have encouraged exercise as a treatment method for improving the health of those with schizophrenia. Furthermore, the long-term physical and mental effects of consistent exercise on people with schizophrenia are not well-known. This study will evaluate the impact of motivational guidance to exercise on people with schizophrenia, based on their attendance, persistence, and compliance to a walking program.

Participants in this study will be randomly assigned to one of two groups. Both groups will continue their regular medications and treatments throughout the study. Upon entry, members of both groups will complete the same two forms concerning attitudes toward exercise. Group 1 participants will attend weekly 1-hour exercise information sessions for 4 weeks. Group 2 participants will attend weekly 1-hour general health information sessions for the same 4 weeks. Participants of both groups will then take part in identical 16-week walking programs. The walking program will consist of three 30- to 50-minute walks per week, including 10 minutes of warm up and 10 minutes of cool down stretching. All participants will gradually increase their walking time from 5 minutes to 30 minutes during the program. At the completion of the walking programs, participants of both groups will complete repeat forms about their attitudes toward exercise. There will be no follow-up visits for the participants.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Motivating Persons With Schizophrenia to Exercise
Study Start Date : November 2007
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Exercise information group
Behavioral: Motivational group sessions
Motivational group sessions include 4 weeks of weekly 1-hour exercise information sessions.
Active Comparator: 2
General health information group
Other: Time and attention control group sessions
Time and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions.

Outcome Measures

Primary Outcome Measures :
  1. Exercise group attendance [ Time Frame: Measured at Week 16 ]
  2. Exercise group persistence [ Time Frame: Measured at Weeks 4,8, 12 & 16 ]
  3. Exercise group compliance [ Time Frame: Measured at Weeks 4,8,12 & 16 ]
  4. Exercise attitude [ Time Frame: Measured at Weeks 4,8,12 and 16 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets DSM-IV criteria for schizophrenia
  • Speaks English
  • Stable medication regimen
  • Able to receive medical clearance for moderate exercise

Exclusion Criteria:

  • Hospitalized within 1 year of study entry for angina, heart attack, or cardiac surgery
  • Diagnosed with congestive heart failure
  • Has a pacemaker
  • Heart rate less than 50 bpm or more than 100 bpm at rest
  • Uncontrolled hypertension
  • History of spinal or hip fracture
  • Unable to walk or move around without assistance
  • Any other medical condition, in the opinion of primary care provider, that would prevent safe participation in the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559572

United States, Tennessee
Helen Ross McNabb Center
Knoxville, Tennessee, United States, 37917
Sponsors and Collaborators
The University of Tennessee, Knoxville
National Institute of Mental Health (NIMH)
Principal Investigator: Lora L. Beebe, PhD, PMHNP, BC University of Tennessee
More Information

Responsible Party: Brenda Lawson, Compliance Officer, IRB Administrator, The University of Tennessee Knoxville
ClinicalTrials.gov Identifier: NCT00559572     History of Changes
Other Study ID Numbers: R03MH079047 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Brenda Lawson, The University of Tennessee Knoxville:
Group Counseling

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders