| 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). | Includes participants with data at Baseline and Post Treatment | Posted | | Mean | Standard Deviation | meters | | Baseline, Post Treatment (24 weeks) | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Post Treatment and Follow-Up | Posted | | Mean | Standard Deviation | meters | | Post Treatment (24 weeks), Follow-Up (Up to 28 weeks) | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | score on a scale | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | score on a scale | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | kg/m^2 | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | mmHg | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | mmHg | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | beats per minute | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | centimeters | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | kilograms | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| Other Pre-specified | 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | score on a scale | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| Other Pre-specified | 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | score on a scale | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| Other Pre-specified | 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up | Posted | | Mean | Standard Deviation | score on a scale | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| Other Pre-specified | 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up. If estimate is missing for baseline or posttest, the closest point within three weeks was used as an estimate. | Posted | | Median | Full Range | steps per day | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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| Other Pre-specified | 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). | Includes participants with data at Baseline, Post Treatment, and Follow-Up. If estimate is missing for baseline or posttest, the closest point within three weeks was used as an estimate | Posted | | Median | Full Range | minutes per week | | Up to 28 weeks | | | | ID | Title | Description |
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| OG000 | Single Arm Experimental Walking Group | 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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it. |
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