Schizophrenia Clinical Trial
— PACE-lifeOfficial title:
Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life
Verified date | July 2020 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | September 11, 2019 |
Est. primary completion date | September 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | North Carolina Psychiatric Research Center | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2) | Mean difference in weighted average motivation score (relative autonomy index) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. Zero corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from -24 to +20. Each subscale is calculated from averages (items scored 0-4) and then a weight is applied. Higher scores reflect better outcomes (higher autonomous motivation to exercise). | Up to 28 weeks | |
Other | Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE) | Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 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 for each subscale range from 1 to 5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise). | Up to 28 weeks | |
Other | Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS) | Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). 2. The BPNS is a 21-item self-report scale. Answers are on a 7 point Likert scale ranging from "Not at all true" to "Very true." Possible scores for each subscale range from 1 to 7. Higher scores reflect better outcomes (i.e more psychological needs being met). | Up to 28 weeks | |
Other | Median Difference in Daily Steps From Fitbit Devices | Median difference in steps/day from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record steps taken. Higher scores reflect better outcomes (higher steps/day). | Up to 28 weeks | |
Other | Median Difference in Minutes Spent Walking From Fitbit Devices | Median difference in weekly minutes spent walking from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record minutes spent walking in bouts of 15 minutes. Higher scores reflect better outcomes (higher weekly minutes spent walking). | Up to 28 weeks | |
Primary | Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24 | 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 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness). | Baseline, Post Treatment (24 weeks) | |
Primary | Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28 | 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 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness). | Post Treatment (24 weeks), Follow-Up (Up to 28 weeks) | |
Secondary | Mean Difference Overall UCLA Loneliness Scale Score | Mean difference in overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 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). | Up to 28 weeks | |
Secondary | Mean Difference Overall PANSS Score | Mean difference in the overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 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). | Up to 28 weeks | |
Secondary | Mean Difference in Body Mass Index (BMI) | Mean difference in body mass index (BMI) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Higher scores reflect worse outcomes (i.e. greater body mass). | Up to 28 weeks | |
Secondary | Mean Difference in Diastolic Blood Pressure Change | Mean difference in diastolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal diastolic blood pressure ranges from = 70 to higher than 120 mmHg. Higher scores reflect worse outcomes (i.e., higher diastolic blood pressure). | Up to 28 weeks | |
Secondary | Mean Difference in Systolic Blood Pressure Change | Mean difference in systolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal systolic blood pressure ranges from =120 to higher than 140 mmHg. Higher scores reflect worse outcomes (i.e., higher systolic blood pressure). | Up to 28 weeks | |
Secondary | Mean Difference in Resting Heart Rate Change | Mean difference in resting heart rate change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal heart rate ranges from = 60 to higher than 100. Higher scores reflect worse outcomes (poorer heart condition). | Up to 28 weeks | |
Secondary | Mean Difference in Waist Circumference | Mean difference in waist circumference from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal waist circumference ranges = than 94cm for males and < than 80 for females to higher than 102 cm for males and 88cm for females . Higher scores reflect worse outcomes (i.e. greater waist circumference = disease development risk). | Up to 28 weeks | |
Secondary | Mean Difference in Weight | Mean difference in weight from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal weight ranges from 45 to 130 kilograms . Higher scores reflect worse outcomes (i.e., greater weight). | Up to 28 weeks |
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