Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life

NCT03757988 | Completed Results

• 2 other identifiers: 18-12961R34MH111852-01A1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Walking; Exercise; Physical Health

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline, Post Treatment (24 weeks)

• 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).

  Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)

Secondary Outcomes (8)

• Mean Difference Overall UCLA Loneliness Scale Score

  Up to 28 weeks

• Mean Difference Overall PANSS Score

  Up to 28 weeks

• Mean Difference in Body Mass Index (BMI)

  Up to 28 weeks

• Mean Difference in Diastolic Blood Pressure Change

  Up to 28 weeks

• Mean Difference in Systolic Blood Pressure Change

  Up to 28 weeks

Other Outcomes (5)

• Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2)

  Up to 28 weeks

• Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE)

  Up to 28 weeks

• Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS)

  Up to 28 weeks

Study Arms (1)

Single Arm Experimental Walking Group

EXPERIMENTAL

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.

Behavioral: Exercise Intervention- PACE-Life

Interventions

Exercise Intervention- PACE-Life BEHAVIORAL

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 rate 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 HR that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes.

Single Arm Experimental Walking Group

Eligibility Criteria

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

You may qualify if:

• 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.)

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

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 Penn, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: December 6, 2018
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: September 21, 2020
• Results First Posted: September 21, 2020

Record last verified: 2020-07

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)