NCT00559572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

November 14, 2007

Last Update Submit

January 14, 2013

Conditions

Schizophrenia

Keywords

ExerciseGroup CounselingObesity

Outcome Measures

Primary Outcomes (4)

  • Exercise group attendance

    Measured at Week 16

  • Exercise group persistence

    Measured at Weeks 4,8, 12 & 16

  • Exercise group compliance

    Measured at Weeks 4,8,12 & 16

  • Exercise attitude

    Measured at Weeks 4,8,12 and 16

Study Arms (2)

1

EXPERIMENTAL

Exercise information group

Behavioral: Motivational group sessions

2

ACTIVE COMPARATOR

General health information group

Other: Time and attention control group sessions

Interventions

Motivational group sessionsBEHAVIORAL

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

1
Time and attention control group sessionsOTHER

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

2

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria for schizophrenia
  • Speaks English
  • Stable medication regimen
  • Able to receive medical clearance for moderate exercise

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Ross McNabb Center

Knoxville, Tennessee, 37917, United States

Location

MeSH Terms

Conditions

SchizophreniaMotor ActivityObesity

Interventions

Time

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Lora L. Beebe, PhD, PMHNP, BC

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Compliance Officer, IRB Administrator

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 16, 2007

Study Start

November 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)