Effects of Motivating People With Schizophrenia to Exercise

NCT ID: NCT00559572

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-08-31

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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Exercise information group

Group Type: EXPERIMENTAL

Motivational group sessions

Intervention Type: BEHAVIORAL

Motivational group sessions include 4 weeks of weekly 1-hour exercise information sessions.

2

General health information group

Group Type: ACTIVE_COMPARATOR

Time and attention control group sessions

Intervention Type: OTHER

Time and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions.

Interventions

Motivational group sessions

Motivational group sessions include 4 weeks of weekly 1-hour exercise information sessions.

Intervention Type: BEHAVIORAL

Time and attention control group sessions

Time and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role: lead

Responsible Party

Brenda Lawson

Compliance Officer, IRB Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lora L. Beebe, PhD, PMHNP, BC

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

Helen Ross McNabb Center

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

R03MH079047

Identifier Type: NIH

Identifier Source: secondary_id

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R03MH079047

Identifier Type: NIH

Identifier Source: org_study_id

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