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N/A N=50 Randomized Triple-blind Treatment

Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial

Schizophrenia · Schizoaffective Disorder · Brief Psychotic Disorder · Schizophreniform Disorders · Unspecified Schizophrenia Spectrum and Other Psychotic Disorder

Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Sep 2022
Primary outcome: Primary: Difference in Participant's Total Distance During 6-minute Walk — 458.775; 467.209; 452.355; 448.711 meters

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PACE-Life (Behavioral); Exercise Intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Difference in Participant's Total Distance During 6-minute Walk
458.775; 467.209; 452.355; 448.711
SECONDARY
Mean Difference in Minutes Spent Walking
31.647; 44.278; 55.866; 58.188
SECONDARY
Mean Difference in Daily Steps
4940.529; 5010.667; 4274.429; 4503.875
SECONDARY
Mean Difference Overall UCLA Loneliness Scale Score
48.588; 46.450; 50.133; 47.812
SECONDARY
Mean Difference Overall PANSS Score
62.588; 60.700; 55.467; 61.062
SECONDARY
Mean Difference in Body Mass Index (BMI) Change
36.026; 36.872; 33.553; 36.262
SECONDARY
Mean Difference in Body Weight Change
228.11; 240.88; 220.96; 235.75
SECONDARY
Mean Difference in Waist Circumference
109.88; 112.30; 106.94; 115.94
SECONDARY
Mean Difference in Systolic Blood Pressure Change
125; 129.167; 122; 124.867
SECONDARY
Mean Difference in Diastolic Blood Pressure Change
77.647; 81.111; 76.000; 78.533
SECONDARY
Mean Difference in Resting Heart Rate Change
77.188; 77.313; 82.133; 80.625

Summary

Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 50 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, which can be completed virtually and in-person (based on participant preference) all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart rate from the watch, to guide the intensity of the walk, will be provided to participants and reviewed at each group session. Participants randomly assigned to the PACE Life virtual walking group sessions will meet the other group members and group leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will exercise for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention. At the completion of the sessions, everyone will take a break for water and review the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to meet with research staff to get assistance on any Fitibit or exercise-related issues.

Eligibility Criteria

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
  • Reading level > 4th grade. Reading level will be measured by WRAT.
  • 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
  • Willing and able to provide informed consent or has legal guardian present to provide informed consent.

Exclusion Criteria

  • Pregnant women will be excluded because pregnancy alters autonomic and immune responsiveness, increase weight gain, and can influence heart rate
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04173572). 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.

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