Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life
Condition: Schizophrenia; Schizoaffective Disorder; Brief Psychotic Disorder; Schizophreniform Disorder; Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional

Summary: 
      Purpose: To develop and test the feasibility of an exercise intervention that combines group
      walking, activity tracking, and heart rate monitoring, and determine the effectiveness of
      this intervention on the physical and mental health for individuals with schizophrenia
      spectrum disorders.

      Participants: 14 individuals with schizophrenia spectrum disorders.

      Procedures (methods): During the baseline assessment, subjects will be provided with a Fitbit
      wristband and instructed how to use it. During the first group session, subjects will be
      taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk
      (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to
      determine the appropriate heart from the watch, which will be used to guide the intensity of
      the walk will be provided to subjects and reviewed at each group session. For all clinic
      based group sessions, subjects will arrive at the STEP clinic to meet the entire group and
      leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that
      group session. Next, the group will go outside and walk for 30 minutes. At the completion of
      30 minutes, everyone will go back into the clinic for water and review of the walk. After the
      second group session of each week, subjects will receive weekly progress reports of their
      steps and minutes spent walking the prior week (obtained from Fitbit devices). During this
      session, subjects will also set individual goals for the upcoming week for both their
      "intensity walks" and total steps per day.
    

Detailed description: 
      Overview of Procedures: PACE-life will be integrated into the Schizophrenia Treatment and
      Evaluation Program (STEP) outpatient clinics in Raleigh, NC and Carrboro, NC. The group walks
      will occur in the surrounding area around the clinics on sidewalks, bike trails, and
      residential streets. Goal setting groups and all assessments will take place in a conference
      room at the clinic. Goal-setting will include setting goals for the upcoming week in terms of
      number of steps as well as how many intensity walks that individuals plan to complete.

      Assessments/Measures: The exercise intervention, PACE-Life, will last for 24 weeks and
      includes both group walks and independent walks (done at a location of the subject's
      choosing). Participants will be asked to complete assessments at screening, baseline,
      mid-point, post-test, and 1-month follow-up (approximately 28 weeks total).

      At Screening the following measures will be examined: Demographics, the Wechsler Abbreviated
      Scale of Intelligence (WASI), a licensed physician will complete a medical history and
      physical exam, Physical Activity Readiness Questionnaire (PAR-Q).

      At 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), Self-determination Basic Needs, the Basic Psychological Need
      Scale-in General, the Basic Psychological Needs in Exercise Scale (BPNES), the Mini
      International Neuropsychiatric Interview (MINI) (Baseline Only), 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 subjects regarding satisfaction and acceptability that will have both forced choice
      and open-ended questions.

      Intervention- Groups will occur twice per week for 30 minutes for the entire intervention
      without changes in frequency and duration. The intensity, however, of both group walks and
      home-based walks will increase throughout this 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.
    

Intervention name(s): Exercise Intervention- PACE-Life
Intervention type(s): Behavioral
Intervention description(s): Subjects will be provided with a Fitbit wristband and instructed how to use it. During the first group session, subjects will be taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart rate from the watch, which will be used to guide the intensity of the walk will be provided to subjects and reviewed at each group session. For all clinic based group sessions, subjects will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the HR that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Walking; Exercise; Physical Health