Clinical trial NCT04173572: Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial
Official title: Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Brief Psychotic Disorder
Schizophreniform Disorders
Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
Keywords: Walking
Exercise
Physical Health
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-11-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* DSM-V diagnosis of a SSD (Schizophrenia, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, and Unspecified Schizophrenia Spectrum and Other Psychotic Disorder)
* Between the ages of 18-65, both genders, and any ancestry
* Reading level \> 4th grade. Reading level will be measured by WRAT.
* No hospitalizations for psychiatric reasons in the last 3 months
* Clinically stable (no psychiatric medication changes within the past month)
* Are not already engaging in consistent moderate-intensity exercise (cutoff = 60 min/week for the past 6 months)
* Present with no contra-indication to engage in regular moderate intensity exercise based on the American College of Sports Medicine guidelines
* Willing and able to provide informed consent or has legal guardian present to provide informed consent.

Exclusion Criteria:

* Pregnant women will be excluded because pregnancy alters autonomic and immune responsiveness, increase weight gain, and can influence heart rate

Primary outcomes:
measure: Difference in Participant's Total Distance During 6-minute Walk
timeFrame: Baseline and the last study visit (Up to 20 weeks)
Secondary outcomes:
measure: Mean Difference in Minutes Spent Walking
timeFrame: Baseline and the last study visit (up to 20 weeks)
measure: Mean Difference in Daily Steps
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference Overall UCLA Loneliness Scale Score
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference Overall PANSS Score
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Body Mass Index (BMI) Change
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Body Weight Change
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Waist Circumference
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Systolic Blood Pressure Change
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Diastolic Blood Pressure Change
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Resting Heart Rate Change
timeFrame: Baseline and the last study visit (Up to 20 weeks)
Other outcomes:
measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2)
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES)
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES)
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS)
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: Mean Difference in Composite Score on the Autonomy Support Scale
timeFrame: Baseline and the last study visit (Up to 20 weeks)
measure: End of Study Survey
timeFrame: Post treatment only (16 weeks)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Psychiatric Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: David L Penn, PhD
role: PRINCIPAL_INVESTIGATOR
References: