N/A
Completed N=17
Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life
Schizophrenia · schizoaffective disorder · Brief Psychotic Disorder · Schizophreniform Disorder
Source: ClinicalTrials.gov NCT03757988 ↗
Enrolled (actual)
17
Serious AEs
17.7%
Results posted
Sep 2020
Primary outcomePrimary: Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24 — 92.420 meters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24 |
92.420 | — |
| PRIMARY Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28 |
6.65 | — |
| SECONDARY Mean Difference Overall UCLA Loneliness Scale Score |
0.133; -1.778 | — |
| SECONDARY Mean Difference Overall PANSS Score |
8.267; -2.778 | — |
| SECONDARY Mean Difference in Body Mass Index (BMI) |
0.280; 0.022 | — |
| SECONDARY Mean Difference in Diastolic Blood Pressure Change |
5.667; 5.333 | — |
| SECONDARY Mean Difference in Systolic Blood Pressure Change |
1.733; 11.111 | — |
| SECONDARY Mean Difference in Resting Heart Rate Change |
1.533; 2.667 | — |
| SECONDARY Mean Difference in Waist Circumference |
2.533; -0.667 | — |
| SECONDARY Mean Difference in Weight |
0.887; 0.556 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03757988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.