Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial
Condition: Schizophrenia; Schizoaffective Disorder; Brief Psychotic Disorder; Schizophreniform Disorders; 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 test the effectiveness of an exercise intervention that combines group walking,
      activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life,
      PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum
      disorder.

      Participants: 50 individuals with schizophrenia spectrum disorders.

      Procedures (methods): During the baseline assessment, which can be completed virtually and
      in-person (based on participant preference) all participants will be provided with a Fitbit
      wristband and instructed how to use it. During the first group session, participants will be
      taught how to use their heart rate (on the Fitbit) to determine how fast participants should
      walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how
      to determine the appropriate heart rate from the watch, to guide the intensity of the walk,
      will be provided to participants and reviewed at each group session. Participants randomly
      assigned to the PACE Life virtual walking group sessions will meet the other group members
      and group leaders and be reminded of the heart rate (HR) that corresponds with the intensity
      of that group session. Next, the group will exercise for 15 minutes in the first two weeks,
      progressing to 30-minute walking sessions over the course of the intervention. At the
      completion of the sessions, everyone will take a break for water and review the walk. After
      the second group session of each week, participants will receive weekly progress reports of
      their steps and minutes spent walking the prior week (obtained from Fitbit devices). During
      this session, participants will also set individual goals for the upcoming week for both
      their "intensity walks" and total steps per day.

      Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it
      by study staff. Participants will also be given information on current recommended physical
      activity guidelines (150 min/week of moderate intensity exercise) and will be told that study
      staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like
      participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive
      days) or to troubleshoot any issues. If necessary, participants might be invited to meet with
      research staff to get assistance on any Fitibit or exercise-related issues.
    

Detailed description: 
      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.
    

Intervention name(s): PACE-Life; Exercise Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.; Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Other intervention name(s): Exercise Intervention; Fitbit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Walking; Exercise; Physical Health