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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00559572 |
Purpose
This study will evaluate the impact of motivational guidance to exercise on people with schizophrenia, based on their participation in a walking program.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Behavioral: Motivational group sessions Other: Time and attention control group sessions |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Motivating Persons With Schizophrenia to Exercise |
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 22 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lora L. Beebe, Phd, PMHNP-BC | 865-974-3978 | lbeebe1@utk.edu |
| United States, Tennessee | |
| Helen Ross McNabb Center | Recruiting |
| Knoxville, Tennessee, United States, 37917 | |
| Principal Investigator: | Lora L. Beebe, PhD, PMHNP, BC | University of Tennessee |
More Information
| Responsible Party: | Lora L. Beebe, PhD, PMHNP, BC, University of Tennessee |
| ClinicalTrials.gov Identifier: | NCT00559572 History of Changes |
| Other Study ID Numbers: | R03 MH079047 |
| Study First Received: | November 14, 2007 |
| Last Updated: | March 12, 2009 |
| Health Authority: | United States: Federal Government |
|
Exercise Group Counseling Obesity |
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |