SchizophreniaNCT00559572
Effects of Motivating People With Schizophrenia to Exercise
A study testing Motivational group sessions in people with Schizophrenia, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
This study will evaluate the impact of motivational guidance to exercise on people with schizophrenia, based on their participation in a walking program. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Motivational group sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for schizophrenia
- Speaks English
- Stable medication regimen
- Able to receive medical clearance for moderate exercise
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen Ross McNabb Center
Knoxville, Tennessee, 37917
About this study
Official title: 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.
Read the 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
- Being tested
- Motivational group sessions, Time and attention control group sessions
- Keywords
- Exercise, Group Counseling, Obesity
- Medical subject headings
- Schizophrenia, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational group sessionsBehavioural
Motivational group sessions include 4 weeks of weekly 1-hour exercise information sessions.
Time and attention control group sessionsOther
Time and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise information group Receives: Behavioral: Motivational group sessions |
| 2 | Active comparator | General health information group Receives: Other: Time and attention control group sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise group attendance
Measured: Measured at Week 16
Exercise group persistence
Measured: Measured at Weeks 4,8, 12 & 16
Exercise group compliance
Measured: Measured at Weeks 4,8,12 & 16
Exercise attitude
Measured: Measured at Weeks 4,8,12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Brenda Lawson, The University of Tennessee, Knoxville
- Investigators
- Lora L. Beebe, PhD, PMHNP, BC, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559572
- Sponsor's protocol ID
- R03MH079047
- Other IDs
- R03MH079047
- Status last verified
- Jan 2013
- First submitted
- 14 Nov 2007
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Persons With Schizophrenia to Exercise
- ClinicalTrials.gov ID
- NCT00559572
- Acronym / sponsor ID
- R03MH079047
- Conditions
- Schizophrenia
- Keywords
- Exercise, Group Counseling, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motivational group sessionsExercise information group |
| 2 | Active comparator | Other: Time and attention control group sessionsGeneral health information group |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets DSM-IV criteria for schizophrenia
- Speaks English
- Stable medication regimen
- Able to receive medical clearance for moderate exercise
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational group sessionsMotivational group sessions include 4 weeks of weekly 1-hour exercise information sessions. | Behavioural | 1 |
| Time and attention control group sessionsTime and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions. | Other | 2 |
Primary outcome
Exercise group attendance
Time frame: Measured at Week 16
Exercise group persistence
Time frame: Measured at Weeks 4,8, 12 & 16
Exercise group compliance
Time frame: Measured at Weeks 4,8,12 & 16
Exercise attitude
Time frame: Measured at Weeks 4,8,12 and 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora L. Beebe, PhD, PMHNP, BC principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational group sessions in people with Schizophrenia, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise group attendance (time frame: Measured at Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.