Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial : Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial

Overview of Procedures: The PACE-Life Group will be integrated into the Schizophrenia Treatment and Evaluation Program (STEP) outpatient clinics in Raleigh, NC and Carrboro, NC. The group walks will occur on a secure online platform (Zoom). Goal-setting groups and all assessments will also take place on a secure online platform (Zoom). Goal-setting will include setting goals for the upcoming week in terms of number of steps as well as how many intensity walks individuals plan to complete. Clinic-based group sessions will also include if-then plans and problem solving any issues that interfere with home-based walks.The Fitbit Alone participants will be given a Fitbit and instructed on how to use them as well as information on current recommended physical activity guidelines. Participants will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like they are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. If necessary participants may be invited to meet with research staff to receive assistance on any Fitbit or exercise-related issues.Assessments/Measures: The exercise intervention, PACE-Life, will last for 16 weeks and includes both virtual group walks and independent walks. Participants will be asked to complete assessments (either virtually or in-person based on preference) at screening, baseline, mid-point, post-test, and 1-month follow-up.At Screening the following measures will be examined: Demographics, the Wide Range Achievement Test (WRAT), a licensed physician will complete a medical history and physical exam to provide medical clearance for participants, Physical Activity Readiness Questionnaire (PAR-Q) and the -the Mini-International Neuropsychiatric Interview (MINI) will be used to verify that participants have a schizophrenia spectrum diagnosis before they are enrolled in the study.At the Baseline, Mid-point, Post-test, and 1-Month Follow-up the following measures will be examined: Demographics, Minutes Spent Walking, the Short Form International Physical Activity Questionnaire (IPAQ), Steps/day, Cardiorespiratory fitness (CRF)- CRF will be measured using the 6-minute walk test (6MWT), if in person, or compute CRF based on an equation by Jackson, A.S., et al (1990) that includes recent weight and height, for the calculation of BMI, gender, self-reported physical activity level, and age, Self-determination Basic Needs, the Basic Psychological Need Scale-in General, the Basic Psychological Needs in Exercise Scale (BPNES), the Positive and Negative Syndrome Scale (PANSS), Resting Systolic/Diastolic Blood Pressure and resting heart rate (RHR), autonomous motivation will be measured with the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2), enjoyment of walking will be measured with the Physical Activity Enjoyment Scale (PACES), the UCLA Loneliness Scale, Weight, BMI, and Waist/hip Circumference.At the conclusion of the open trial, the investigators will administer a brief questionnaire to the participants regarding satisfaction and acceptability that will include both Likert ratings and open-ended questions.Intervention- PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout the intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.Fitbits: All participants will be provided a Fitbit that is labeled with a participant number. All Fitbits are paired to a Fitbit account. Data from Fitbit devices can be synced to the corresponding account and accessed through Fitbit.com. Participants will be provided information about their accounts should participants want to look at the data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking.Protocol Changes due to COVID-19 Pandemic:Protocol changes due to the COVID-19 pandemic have been formalized and made permanent as outlined above. Additionally, walking groups will take place virtually, on a secure online platform (Zoom). The Wide Range Achievement Test (WRAT) will be used instead of the Wechsler Abbreviated Scale of Intelligence (WASI) to measure a minimum reading level (4th grade) to participate in the study..

Medienart:	Klinische Studie

Erscheinungsjahr:	2022
Erschienen:	2022

Enthalten in:	ClinicalTrials.gov - (2022) vom: 22. Sept. Zur Gesamtaufnahme - year:2022

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Disease Medical Condition: Schizophrenia, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorders, Unspecified Schizophrenia Spectrum and Other Psychotic Disorder Mental Disorders Psychotic Disorders Recruitment Status: Completed Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: November 22, 2019, Last downloaded: ClinicalTrials.gov processed this data on September 26, 2022, Last updated: September 28, 2022

Study ID:	NCT04173572 19-2286 1R34MH111852-01A1
Veröffentlichungen zur Studie:

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PPN (Katalog-ID):	CTG003226905