Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/13/2018 |
| Start Date: | December 6, 2018 |
| End Date: | September 2019 |
| Contact: | David L Penn, PhD |
| Email: | dpenn@ad.unc.edu |
| Phone: | 919-843-7514 |
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.
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.
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.
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.
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.
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.
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;
- 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.
We found this trial at
2
sites
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-843-7514
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