Benefits of Physical Exercise in Schizophrenia

NCT02716584 | Completed Results

• 2 other identifiers: D2026-P1I21RX002026
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Impairments in social integration, characterized by low marriage rates, few friendships, and a high frequency of living alone, affect the vast majority of Veterans with schizophrenia. The primary aim of this proposal is to test the efficacy of a novel rehabilitation treatment approach, engaging in physical exercise, at improving two determinants of social integration which are impaired in schizophrenia: cognition and affect.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (6)

• VO2max

  Measure of aerobic capacity (VO2max) is derived by using a regression formula based on age, weight, sex, and time to complete walking of one mile. Because scores are derived using a regression equation, there is no absolute minimum or maximum value; higher scores represent better aerobic capacity.

  Change from baseline to 12-week endpoint assessment

• Total Score for Social Functioning

  Birchwood Social Functioning Scale is a measure of social functioning. The total score for social functioning is calculated by summing the raw scores from each of the seven subscales (social engagement, interpersonal communication, independence - performance, independence - competence, recreation, prosocial behavior, employment); possible range is 0 to 223 with higher scores representing better social functioning.

  Change from baseline to 12 week endpoint assessment

• Total Score for Speed of Processing (i.e., Cognition) as Assessed by the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Test

  Brief Assessment of Cognition in Schizophrenia (BACS) is a measure of speed of information processing. The total score for speed of processing (i.e., cognition) is calculated by summing the number of symbol-code pairs completed correctly on the BACS Symbol Coding test within the allotted 90 second time limit. Scores range from 0 to 110 with higher scores representing better information processing speed.

  Change from baseline to 12-week endpoint assessment

• Total Score for Positive Affect as Assessed by the Positive and Negative Affect Scale (PANAS)

  Positive and Negative Affect Scale is a measure of an individual's positive and negative affect. The scale includes 32 items; 16 denote positive affect and 16 denote negative affect. Each item is rated on a scale of 1 (very slightly or not at all) to 5 (extremely). The total score for PANAS positive affect is calculated by summing the ratings for items denoting positive affect. Scores range from 16 to 80; higher scores represent better positive affect.

  Change from baseline to the 12-week endpoint assessment

• Total Score for Negative Affect as Assessed by the Positive and Negative Affect Scale (PANAS)

  Positive and Negative Affect Scale is a measure of an individual's positive and negative affect. The scale includes 32 items; 16 denote positive affect and 16 denote negative affect. Each item is rated on a scale of 1 (very slightly or not at all) to 5 (extremely). The total score for PANAS negative affect is calculated by summing the ratings for items denoting negative affect. Scores range from 16 to 80; lower scores represent better levels of negative affect.

  Change from baseline to the 12-week endpoint assessment

• Composite Score From Non-social Cognition Battery

  Raw scores (i.e., total scores) for the following tests will be transformed to z-scores: attention (CPT-IP), speed of processing (BACS symbol coding), working memory (WAIS-IV letter-number sequencing test), verbal learning (Hopkins Verbal Learning Test - Revised), and executive control (AX-CPT). The outcome measure is the mean z-score. The composite z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean of the overall sample of study participants. Negative numbers indicate values lower than other study participants and positive numbers indicate values higher than other study participants.

  Change from baseline to the 12-week endpoint assessment

Secondary Outcomes (4)

• Composite Score From Social Cognition Battery

  Change from baseline to the 12-week endpoint assessment

• BDNF Value

  Change from baseline to the 12-week endpoint assessment

• Positive Symptom Subscale Score From the BPRS

  Change from baseline to the 12-week endpoint assessment

• Negative Symptom Subscale Score From the BPRS

  Change from baseline to the 12-week endpoint assessment

Study Arms (2)

Physical exercise

EXPERIMENTAL

Participants participate in brisk walking exercises.

Behavioral: Physical exercise

Stretching exercise

ACTIVE COMPARATOR

Participants participate in non-aerobic, non-Yoga stretching exercises

Behavioral: Stretching exercise

Interventions

Physical exercise BEHAVIORAL

Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, held 3 times per week, gradually increasing walking time until reaching a maximum of 40-minutes per session. The heart rate of each Veteran will be monitored during the walking sessions to help ensure maintenance of a target peak heart rate of 60% to 70% of the maximum for the individual's age (i.e., 220-age).

Physical exercise

Stretching exercise BEHAVIORAL

Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week.

Stretching exercise

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic and Statistical Manual (DSM) - 5 diagnosis of schizophrenia or schizoaffective disorder;
• age 40-65;
• screened for physical health risks (i.e., no serious heart condition, dizziness, bone or joint problems posing safety concerns, ambulatory limitations);
• clinically stable (e.g., no inpatient hospitalizations for 3 months prior to enrollment; no change in type of antipsychotic medication in the past 4 weeks)

You may not qualify if:

• evidence of alcohol or substance use disorder (moderate or greater severity) per DSM-5 criteria in the past 3 months;
• clinically significant neurological disease as determined by medical history (e.g., seizure disorder);
• history of serious head injury with loss of consciousness \>1 hour;
• participation in an exercise program within past 6 months;
• not able to understand spoken and written English sufficiently to comprehend consent procedures.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (5)

• Malchow B, Reich-Erkelenz D, Oertel-Knochel V, Keller K, Hasan A, Schmitt A, Scheewe TW, Cahn W, Kahn RS, Falkai P. The effects of physical exercise in schizophrenia and affective disorders. Eur Arch Psychiatry Clin Neurosci. 2013 Sep;263(6):451-67. doi: 10.1007/s00406-013-0423-2. Epub 2013 Jul 20.

  PMID: 23873090 BACKGROUND

• Knochel C, Oertel-Knochel V, O'Dwyer L, Prvulovic D, Alves G, Kollmann B, Hampel H. Cognitive and behavioural effects of physical exercise in psychiatric patients. Prog Neurobiol. 2012 Jan;96(1):46-68. doi: 10.1016/j.pneurobio.2011.11.007. Epub 2011 Nov 24.

  PMID: 22120173 BACKGROUND

• Kimhy D, Vakhrusheva J, Bartels MN, Armstrong HF, Ballon JS, Khan S, Chang RW, Hansen MC, Ayanruoh L, Lister A, Castren E, Smith EE, Sloan RP. The Impact of Aerobic Exercise on Brain-Derived Neurotrophic Factor and Neurocognition in Individuals With Schizophrenia: A Single-Blind, Randomized Clinical Trial. Schizophr Bull. 2015 Jul;41(4):859-68. doi: 10.1093/schbul/sbv022. Epub 2015 Mar 23.

  PMID: 25805886 BACKGROUND

• Heggelund J, Kleppe KD, Morken G, Vedul-Kjelsas E. High aerobic intensity training and psychological States in patients with depression or schizophrenia. Front Psychiatry. 2014 Oct 30;5:148. doi: 10.3389/fpsyt.2014.00148. eCollection 2014.

  PMID: 25400592 BACKGROUND

• Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193.

  PMID: 20124113 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Exercise; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Robert Kern
• Organization: VA Greater Los Angeles Healthcare System

Robert.Kern2@va.gov

310-478-3711

Study Officials

• Robert S. Kern, PhD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 23, 2016
• Study Start: September 1, 2016
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: September 19, 2019
• Results First Posted: September 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol and SAP will be available one year after study completion and will be available indefinitely.
• Access Criteria: The study protocol and SAP will be available to the public domain.

Locations

US (1)