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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00286299
Other study ID # 4.2005.1507
Secondary ID
Status Completed
Phase N/A
First received February 2, 2006
Last updated March 28, 2017
Start date October 2005
Est. completion date July 2008

Study information

Verified date March 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Intervention

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.
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.
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.

Locations

Country Name City State
Norway St. Olavs Hospital, Department of Psychiatry Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Central Norway Regional Health Authority, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary peak aerobic capacity (VO2peak) Pre- and Posttest
Secondary Positive and Negative Syndrome Scale (PANSS) Pre- and Posttest
Secondary Calgary Depression Scale for Schizophrenia (CDSS) Pre- and Posttest
Secondary The 36-item short form (SF-36) Pre- and Posttest
Secondary 60 Watt walking efficiency, Net efficiency Pre- and Posttest
Secondary Maximal strength, measured as one repetition maximum (1RM) in a incline leg press machine (Technogym) Pre- and Post test
Secondary Fasting blood samples, systolic and diastolic blood pressure. Pre- and posttest
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