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Effects of Motivating People With Schizophrenia to Exercise
This study is currently recruiting participants.
Study NCT00559572   Information provided by National Institute of Mental Health (NIMH)
First Received: November 14, 2007   Last Updated: March 12, 2009   History of Changes

November 14, 2007
March 12, 2009
November 2007
August 2009   (final data collection date for primary outcome measure)
  • Exercise group attendance [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]
  • Exercise group persistence [ Time Frame: Measured at Weeks 4,8, 12 & 16 ] [ Designated as safety issue: No ]
  • Exercise group compliance [ Time Frame: Measured at Weeks 4,8,12 & 16 ] [ Designated as safety issue: No ]
  • Exercise attitude [ Time Frame: Measured at Weeks 4,8,12 and 16 ] [ Designated as safety issue: No ]
  • Exercise group attendance [ Time Frame: Measured at Week 16 ]
  • Exercise group persistence [ Time Frame: Measured at Week 16 ]
  • Exercise group compliance [ Time Frame: Measured at Week 16 ]
  • Exercise attitude [ Time Frame: Measured at Weeks 4 and 16 ]
Complete list of historical versions of study NCT00559572 on ClinicalTrials.gov Archive Site
 
 
 
Effects of Motivating People With Schizophrenia to Exercise
Motivating Persons With Schizophrenia to Exercise

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

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.

 
Interventional
Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Schizophrenia
  • Behavioral: Motivational group sessions
  • Other: Time and attention control group sessions
  • Experimental: Exercise information group
  • Active Comparator: General health information group
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
22 Years and older
No
Contact: Lora L. Beebe, Phd, PMHNP-BC 865-974-3978 lbeebe1@utk.edu
United States
 
NCT00559572
Lora L. Beebe, PhD, PMHNP, BC, University of Tennessee
R03 MH079047
National Institute of Mental Health (NIMH)
 
Principal Investigator: Lora L. Beebe, PhD, PMHNP, BC University of Tennessee
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP