- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00559572
Effects of Motivating People With Schizophrenia to Exercise
Motivating Persons With Schizophrenia to Exercise
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37917
- Helen Ross McNabb Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
Exercise information group
|
Motivational group sessions include 4 weeks of weekly 1-hour exercise information sessions.
|
Aktiver Komparator: 2
General health information group
|
Time and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Exercise group attendance
Zeitfenster: Measured at Week 16
|
Measured at Week 16
|
Exercise group persistence
Zeitfenster: Measured at Weeks 4,8, 12 & 16
|
Measured at Weeks 4,8, 12 & 16
|
Exercise group compliance
Zeitfenster: Measured at Weeks 4,8,12 & 16
|
Measured at Weeks 4,8,12 & 16
|
Exercise attitude
Zeitfenster: Measured at Weeks 4,8,12 and 16
|
Measured at Weeks 4,8,12 and 16
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Lora L. Beebe, PhD, PMHNP, BC, University of Tennessee
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R03MH079047 (US NIH Stipendium/Vertrag)
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