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

NCT04173572 | Completed Results

• 2 other identifiers: 19-22861R34MH111852-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Walking; Exercise; Physical Health

Outcome Measures

Primary Outcomes (1)

• Difference in Participant's Total Distance During 6-minute Walk

  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).

  Baseline and the last study visit (Up to 20 weeks)

Secondary Outcomes (10)

• Mean Difference in Minutes Spent Walking

  Baseline and the last study visit (up to 20 weeks)

• Mean Difference in Daily Steps

  Baseline and the last study visit (Up to 20 weeks)

• Mean Difference Overall UCLA Loneliness Scale Score

  Baseline and the last study visit (Up to 20 weeks)

• Mean Difference Overall PANSS Score

  Baseline and the last study visit (Up to 20 weeks)

• Mean Difference in Body Mass Index (BMI) Change

  Baseline and the last study visit (Up to 20 weeks)

Other Outcomes (6)

• Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2)

  Baseline and the last study visit (Up to 20 weeks)

• Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES)

  Baseline and the last study visit (Up to 20 weeks)

• Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES)

  Baseline and the last study visit (Up to 20 weeks)

Study Arms (2)

Walking Group

EXPERIMENTAL

Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation.

Behavioral: PACE-Life

Fitbit Alone

ACTIVE COMPARATOR

Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues.

Behavioral: Exercise Intervention

Interventions

PACE-Life BEHAVIORAL

PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.

Also known as: Exercise Intervention

Walking Group

Exercise Intervention BEHAVIORAL

Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.

Also known as: Fitbit

Fitbit Alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women will be excluded because pregnancy alters autonomic and immune responsiveness, increase weight gain, and can influence heart rate

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

North Carolina Psychiatric Research Center

Raleigh, North Carolina, 27610, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Limitations and Caveats

This trial began in early 2020, immediately before the onset of the COVID-19 pandemic. As such, the 13 participants in cohort 1 did not have complete trial data. Cohorts 2 and 3 were later run virtually. While a total of 50 participants were enrolled, only 37 of those participants were analyzed as the first 13 participants created data that was deemed unusable and incomparable to the data from cohorts 2 and 3.

Results Point of Contact

• Title: Tonya Elliott
• Organization: University of North Carolina at Chapel Hill

tonya_elliott@med.unc.edu

919-966-3915

Study Officials

• David L Penn, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: December 20, 2019
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.

Locations

US (2)