Clinical trial NCT03757988: Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life
Official title: Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Brief Psychotic Disorder
Schizophreniform Disorder
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: 2018-11-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) diagnosis of a Schizophrenia Spectrum Disorder (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;
* Intelligence Quotient (IQ) \>70. IQ will be assessed using the WASI
* 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. (If an individual answers yes to one item on the of the Physical Activity Readiness Questionnaire (PAR-Q), a questionnaire that assesses cardiovascular risk factors, she/he will be asked to get clearance from a physician prior to participating in the study)
* Willing and able to provide informed consent. (Note: The research assistant will read the consent form with the participant and ask the subject to repeat back the information after each section to determine whether he/she understands the information provided.)

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: Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24
timeFrame: Baseline, Post Treatment (24 weeks)
measure: Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28
timeFrame: Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)
Secondary outcomes:
measure: Mean Difference Overall UCLA Loneliness Scale Score
timeFrame: Up to 28 weeks
measure: Mean Difference Overall PANSS Score
timeFrame: Up to 28 weeks
measure: Mean Difference in Body Mass Index (BMI)
timeFrame: Up to 28 weeks
measure: Mean Difference in Diastolic Blood Pressure Change
timeFrame: Up to 28 weeks
measure: Mean Difference in Systolic Blood Pressure Change
timeFrame: Up to 28 weeks
measure: Mean Difference in Resting Heart Rate Change
timeFrame: Up to 28 weeks
measure: Mean Difference in Waist Circumference
timeFrame: Up to 28 weeks
measure: Mean Difference in Weight
timeFrame: Up to 28 weeks
Other outcomes:
measure: Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2)
timeFrame: Up to 28 weeks
measure: Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE)
timeFrame: Up to 28 weeks
measure: Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS)
timeFrame: Up to 28 weeks
measure: Median Difference in Daily Steps From Fitbit Devices
timeFrame: Up to 28 weeks
measure: Median Difference in Minutes Spent Walking From Fitbit Devices
timeFrame: Up to 28 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 Penn, PhD
role: PRINCIPAL_INVESTIGATOR
References: