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Effects of Motivating People With Schizophrenia to Exercise

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational group sessions
Time and attention control group sessions
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Exercise, Group Counseling, Obesity

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helen Ross McNabb Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Exercise information group

General health information group

Outcomes

Primary Outcome Measures

Exercise group attendance
Exercise group persistence
Exercise group compliance
Exercise attitude

Secondary Outcome Measures

Full Information

First Posted
November 14, 2007
Last Updated
January 14, 2013
Sponsor
The University of Tennessee, Knoxville
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00559572
Brief Title
Effects of Motivating People With Schizophrenia to Exercise
Official Title
Motivating Persons With Schizophrenia to Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Exercise, Group Counseling, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Exercise information group
Arm Title
2
Arm Type
Active Comparator
Arm Description
General health information group
Intervention Type
Behavioral
Intervention Name(s)
Motivational group sessions
Intervention Description
Motivational group sessions include 4 weeks of weekly 1-hour exercise information sessions.
Intervention Type
Other
Intervention Name(s)
Time and attention control group sessions
Intervention Description
Time and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions.
Primary Outcome Measure Information:
Title
Exercise group attendance
Time Frame
Measured at Week 16
Title
Exercise group persistence
Time Frame
Measured at Weeks 4,8, 12 & 16
Title
Exercise group compliance
Time Frame
Measured at Weeks 4,8,12 & 16
Title
Exercise attitude
Time Frame
Measured at Weeks 4,8,12 and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora L. Beebe, PhD, PMHNP, BC
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Ross McNabb Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States

12. IPD Sharing Statement

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Effects of Motivating People With Schizophrenia to Exercise

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