Treatment Effects From Aerobic Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia

Physiological and Psychiatric Effects From Aerobic High Intensity Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia: A Controlled Clinical Trial.

This study investigates treatment effects from aerobic endurance training, maximal strength training and computer game on aerobic capacity, work efficiency and psychiatric symptoms in patients suffering from schizophrenia. The study is a controlled trial. The aim is to describe the population in respect to aerobic capacity and muscular strength. Low aerobic capacity and muscular strength are important risk factors for cardiovascular disease (CVD). The study also aim to evaluate physical and psychiatric effects from physical training. Effects from participation in physical training or computer game on symptoms, depression and quality of life will be investigated. Data will be collected between October 2005 and August 2007.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Schizophrenia
• Intervention / Treatment: Other: Aerobic high-intensity interval training (AIT); Other: Computer game training (CG); Other: Maximal strength training

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7041
    • St. Olavs Hospital, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria: schizophrenia, schizotypal and delusional disorders (F20-F29) according to the international statistical classification of diseases and related health problems, 10th revision (ICD-10) prepared by the World Health Organization. Patients must have stable antipsychotic medication for six weeks prior to participation.

Exclusion criteria: coronary artery disease, chronic obstructive pulmonary disease, not being able to perform physical treadmill testing and exercise, and less than 80% compliance to the training sessions. All subjects go through a physical health examination at inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic interval training (AIT); AIT is 4x4 minutes interval training on a treadmill at 85 to 95 % HRpeak interspersed with 3 min of active resting periods at a work load corresponding to 70 % HRpeak between each interval. Patients performed the intervals walking or running with a minimum of 5 % inclination.	Other: Aerobic high-intensity interval training (AIT); The AIT group trains 4x4 minute interval training on a treadmill at 85-95 % HRpeak interspersed with 3 minutes of active resting periods at a work load corresponding to 70% HRpeak between each interval. All training sessions are monitored and start with a 6 minute warm-up and end with a 5 minute cool-down period at a work load corresponding to 70% HRpeak. Intervals are performed walking or running on a treadmill with a minimum of 5% inclination, 3 times per week for 8 weeks.; Other Names: 4x4 interval
Active Comparator: Computer game training (CG); 36 minutes playing supervised computer games, Tetris, Xbox	Other: Computer game training (CG); The CG spend the same amount of time (36 minutes), training to improve their ability in the computer game, Tetris. Tetris is a game where small shapes called Tetraminoes fall from the top of the Playfield to the bottom. Players must rotate the Tetraminoes as they fall and fit them together to complete lines. When the player fills an entire line with blocks, that line is removed from the screen. If the player cannot complete lines, the blocks will eventually rise past the top of the screen, and the game ends.; Other Names: Tetris THQ Inc., Xbox, Microsoft
Experimental: Maximal strength training (MST); MST is performed in a leg press machine. The weight is lowered in a controlled manner in the eccentric phase until the patient reached 90 degrees in the knee joint. Then the patients has a short stop (~0.5 second) before the weight is moved as rapidly as possible to complete extension. The training volume is 4 sets of 4RM (i.e. 85-90 % 1RM). The training load is increased with 2.5-5 kg each time patients managed to perform 4 sets with the determined load or each training session.	Other: Maximal strength training; Training starts with a 10 minute warm-up on the treadmill. Maximal strength training is then performed in an inclined leg press machine. The subject lifts 4 maximal repetitions that are repeated 4 times after a 2 minute rest period. Subjects are instructed to lift the weight with an intention of maximal mobilization of force. Training load is increased each time the subject manage to perform 4x4 maximal repetitions. Training is carried out 3 times per week in 8 weeks.; Other Names: Leg press machine (Technogym); Olympic weights (Eleiko)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
peak aerobic capacity (VO2peak)	Pre- and Posttest

Secondary Outcome Measures

Outcome Measure	Time Frame
Positive and Negative Syndrome Scale (PANSS)	Pre- and Posttest
Calgary Depression Scale for Schizophrenia (CDSS)	Pre- and Posttest
The 36-item short form (SF-36)	Pre- and Posttest
60 Watt walking efficiency, Net efficiency	Pre- and Posttest
Maximal strength, measured as one repetition maximum (1RM) in a incline leg press machine (Technogym)	Pre- and Post test
Fasting blood samples, systolic and diastolic blood pressure.	Pre- and posttest

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Helse Nord-Trøndelag HF
• Investigators: Study Chair: Geir Nilsberg, M.D., Norwegian University og Science and Technology; Principal Investigator: Jørn Heggelund, M.Sc., Norwegian University of Science and Technology

Publications and helpful links

General Publications

• Heggelund J, Nilsberg GE, Hoff J, Morken G, Helgerud J. Effects of high aerobic intensity training in patients with schizophrenia: a controlled trial. Nord J Psychiatry. 2011 Sep;65(4):269-75. doi: 10.3109/08039488.2011.560278. Epub 2011 Feb 18.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2005
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: February 2, 2006
• First Submitted That Met QC Criteria: February 2, 2006
• First Posted (Estimate): February 3, 2006

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Exercise; Schizophrenia; Mortality; Aerobic capacity
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Cardiovascular Diseases; Schizophrenia
• Other Study ID Numbers: 4.2005.1507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No