Effects of Motivating People With Schizophrenia to Exercise

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brenda Lawson, The University of Tennessee Knoxville
ClinicalTrials.gov Identifier:
NCT00559572
First received: November 14, 2007
Last updated: January 14, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by The University of Tennessee Knoxville:

Primary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: November 2007
Study Completion Date: August 2009
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.

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.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559572

Locations
United States, Tennessee
Helen Ross McNabb Center
Knoxville, Tennessee, United States, 37917
Sponsors and Collaborators
The University of Tennessee Knoxville
Investigators
Principal Investigator: Lora L. Beebe, PhD, PMHNP, BC University of Tennessee
  More Information

No publications provided

Responsible Party: Brenda Lawson, Compliance Officer, IRB Administrator, The University of Tennessee Knoxville
ClinicalTrials.gov Identifier: NCT00559572     History of Changes
Other Study ID Numbers: R03 MH079047, R03MH079047
Study First Received: November 14, 2007
Last Updated: January 14, 2013
Health Authority: United States: Federal Government

Keywords provided by The University of Tennessee Knoxville:
Exercise
Group Counseling
Obesity

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014