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NCT04173572 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
50
Enrollment target

NCT04173572: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT04173572 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04173572, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
50 participants
Enrollment target

Study 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 modera

Primary Outcome

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 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).

Interventions

  • BEHAVIORAL Exercise Intervention
  • BEHAVIORAL PACE-Life

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2019-12-20
Est. Completion 2022-03-23
Phase NA

What the finished NCT04173572 record still lists

NCT04173572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Exercise Intervention is the first listed.

NCT04173572 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04173572 about?

NCT04173572 is a clinical study titled "Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial". 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 indi...

What is the current status of trial NCT04173572?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2019-12-20. Estimated completion is 2022-03-23.

What interventions are being tested in trial NCT04173572?

The interventions under investigation include: Exercise Intervention (BEHAVIORAL), PACE-Life (BEHAVIORAL).

Who is sponsoring clinical trial NCT04173572?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04173572's enrollment target sits among peer trials

50 1279th of 2000 higher than 622 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04173572, the US trial registry maintained by the National Library of Medicine. NCT04173572 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.