An interventional study of Exercise Intervention- PACE-Life in Schizophrenia, Schizoaffective Disorder and Brief Psychotic Disorder, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-21.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 17 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
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This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.
Behavioral: Exercise Intervention- PACE-Life
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 rate 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 HR that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes.
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).
Time frame: Baseline, Post Treatment (24 weeks)
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).
Time frame: Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
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).
Time frame: Up to 28 weeks
| Milestone | Single Arm Experimental Walking Group |
|---|---|
| Started | 17 |
| Completed | 16 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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).
| meters | Single Arm Experimental Walking Group |
|---|---|
| Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24 | 92.420 ± 95.490 |
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).
| meters | Single Arm Experimental Walking Group |
|---|---|
| Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28 | 6.65 ± 32.599 |
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).
| score on a scale | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | 0.133 ± 9.172 |
| Post Treatment to Follow-Up | -1.778 ± 8.511 |
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).
| score on a scale | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | 8.267 ± 12.151 |
| Post Treatment to Follow-Up | -2.778 ± 7.661 |
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).
| kg/m^2 | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | 0.280 ± 1.736 |
| Post Treatment to Follow-Up | 0.022 ± 0.640 |
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).
| mmHg | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | 5.667 ± 12.675 |
| Post Treatment to Follow-Up | 5.333 ± 7.566 |
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).
| mmHg | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | 1.733 ± 10.402 |
| Post Treatment to Follow-Up | 11.111 ± 13.110 |
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).
| beats per minute | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | 1.533 ± 19.460 |
| Post Treatment to Follow-Up | 2.667 ± 13.115 |
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).
| centimeters | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | 2.533 ± 9.226 |
| Post Treatment to Follow-Up | -0.667 ± 2.411 |
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).
| kilograms | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | 0.887 ± 4.659 |
| Post Treatment to Follow-Up | 0.556 ± 1.384 |
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).
| score on a scale | Single Arm Experimental Walking Group |
|---|---|
| Baseline to Post Treatment | -0.906 ± 5.476 |
| Post Treatment to Follow-Up | 0.157 ± 2.379 |
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).
| score on a scale | Single Arm Experimental Walking Group |
|---|---|
| Autonomy scores from Baseline to Post Treatment | 0.383 ± 0.944 |
| Relatedness scores from Baseline to Post Treatment | 0.978 ± 1.483 |
| Competence scores from Baseline to Post Treatment | 0.250 ± 1.225 |
| Autonomy scores from Post Treatment to Follow-Up | -0.222 ± 0.491 |
| Relatedness scores fromPost Treatment to Follow-Up | -0.333 ± 1.080 |
| Competence scores from Post Treatment to Follow-Up | -0.194 ± 0.873 |
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).
| score on a scale | Single Arm Experimental Walking Group |
|---|---|
| Autonomy scores from Baseline to Post Treatment | 0.067 ± 1.132 |
| Relatedness scores from Baseline to Post Treatment | 0.017 ± 0.836 |
| Competence scores from Baseline to Post Treatment | 0.000 ± 0.970 |
| Autonomy scores from Post Treatment to Follow-Up | 0.079 ± 1.050 |
| Relatedness scores fromPost Treatment to Follow-Up | -0.152 ± 0.335 |
| Competence scores from Post Treatment to Follow-Up | -0.019 ± 0.709 |
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).
| steps per day | Single Arm Experimental Walking Group |
|---|---|
| Week 1 to Post Treatment | -228 (-14752 to 3834) |
| Post Treatment to Follow-Up | -31.5 (-6223 to 4291) |
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).
| minutes per week | Single Arm Experimental Walking Group |
|---|---|
| Week 1 to Post Treatment | -55.0 (-1571 to 8) |
| Post Treatment to Follow-Up | 27.5 (-78 to 108) |
Collected over From the time of Informed Consent through follow-up, up to approximately 28 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Experimental Walking Group | 0/17 (0%) | 3/17 (17.6%) | 0/17 (0%) |
| Event | Single Arm Experimental Walking Group |
|---|---|
| Psychiatric Hospitalization Due to Medication Non-AdherencePsychiatric disorders | 2/17 |
| Psychiatric HospitalizationPsychiatric disorders | 1/17 |
| Increased Psychiatric SymptomsPsychiatric disorders | 1/17 |
| Age, Categorical(Participants) | Single Arm Experimental Walking Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 0 |
| Age, Continuous(years) | Single Arm Experimental Walking Group |
|---|---|
| Mean | 38.188 ± 11.743 |
| Sex: Female, Male(Participants) | Single Arm Experimental Walking Group |
|---|---|
| Female | 6 |
| Male | 10 |
| Race/Ethnicity, Customized(Participants) | Single Arm Experimental Walking Group |
|---|---|
| Asian/Pacific Islander | 2 |
| Black or African American | 3 |
| White | 9 |
| Other | 2 |
| Region of Enrollment(Participants) | Single Arm Experimental Walking Group |
|---|---|
| United States | 16 |
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Plan to share: Yes — 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.
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University of North Carolina, Chapel Hill