search
Back to results

Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial ((PACE-life)

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Brief Psychotic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PACE-Life
Exercise Intervention
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Walking, Exercise, Physical Health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill
  • North Carolina Psychiatric Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walking Group

Fitbit Alone

Arm Description

Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation.

Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues.

Outcomes

Primary Outcome Measures

Difference in Participant's Total Distance During 6-minute Walk
The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).

Secondary Outcome Measures

Mean Difference in Minutes Spent Walking
Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 weeks). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.
Mean Difference in Daily Steps
Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.
Mean Difference Overall UCLA Loneliness Scale Score
Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
Mean Difference Overall PANSS Score
Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
Mean Difference in Body Mass Index (BMI) Change
Mean difference in BMI from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e., greater body mass).
Mean Difference in Body Weight Change
Mean difference in body weight change from baseline to last study visit (up to 20 weeks).
Mean Difference in Waist Circumference
Mean difference in waist circumference from baseline to last study visit (up to 20 weeks). Higher scores reflect worse outcomes.
Mean Difference in Systolic Blood Pressure Change
Mean difference in systolic blood pressure change from baseline to last study visit (up to 20 weeks).
Mean Difference in Diastolic Blood Pressure Change
Mean difference in diastolic blood pressure change from baseline to last study visit (up to 20 weeks).
Mean Difference in Resting Heart Rate Change
Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).

Full Information

First Posted
November 20, 2019
Last Updated
August 29, 2022
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04173572
Brief Title
Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial
Acronym
(PACE-life
Official Title
Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
March 23, 2022 (Actual)
Study Completion Date
March 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorders, Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
Keywords
Walking, Exercise, Physical Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking Group
Arm Type
Experimental
Arm Description
Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation.
Arm Title
Fitbit Alone
Arm Type
Active Comparator
Arm Description
Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues.
Intervention Type
Behavioral
Intervention Name(s)
PACE-Life
Other Intervention Name(s)
Exercise Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Other Intervention Name(s)
Fitbit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in Participant's Total Distance During 6-minute Walk
Description
The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Secondary Outcome Measure Information:
Title
Mean Difference in Minutes Spent Walking
Description
Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 weeks). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.
Time Frame
Baseline and the last study visit (up to 20 weeks)
Title
Mean Difference in Daily Steps
Description
Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference Overall UCLA Loneliness Scale Score
Description
Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference Overall PANSS Score
Description
Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Body Mass Index (BMI) Change
Description
Mean difference in BMI from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e., greater body mass).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Body Weight Change
Description
Mean difference in body weight change from baseline to last study visit (up to 20 weeks).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Waist Circumference
Description
Mean difference in waist circumference from baseline to last study visit (up to 20 weeks). Higher scores reflect worse outcomes.
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Systolic Blood Pressure Change
Description
Mean difference in systolic blood pressure change from baseline to last study visit (up to 20 weeks).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Diastolic Blood Pressure Change
Description
Mean difference in diastolic blood pressure change from baseline to last study visit (up to 20 weeks).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Resting Heart Rate Change
Description
Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Other Pre-specified Outcome Measures:
Title
Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2)
Description
Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores are averaged and range from 0-4. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES)
Description
Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores are averaged and range from 1-5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES)
Description
Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores are averaged and range from 1-7. Higher scores reflect better outcomes (greater enjoyment of physical activity).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS)
Description
Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores on each subscale are averaged onto a scale of 1-7. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
Mean Difference in Composite Score on the Autonomy Support Scale
Description
Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.
Time Frame
Baseline and the last study visit (Up to 20 weeks)
Title
End of Study Survey
Description
Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores on each item range from 1-5. Higher scores reflect higher levels of satisfaction and enjoyment in the study.
Time Frame
Post treatment only (16 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Penn, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
North Carolina Psychiatric Research Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.

Learn more about this trial

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

We'll reach out to this number within 24 hrs