NCT00286299

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

February 2, 2006

Last Update Submit

March 28, 2017

Conditions

Keywords

SchizophreniaCardiovascular diseaseAerobic capacityMortalityExercise

Outcome Measures

Primary Outcomes (1)

  • peak aerobic capacity (VO2peak)

    Pre- and Posttest

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Aerobic interval training (AIT)

EXPERIMENTAL

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)

Computer game training (CG)

ACTIVE COMPARATOR

36 minutes playing supervised computer games, Tetris, Xbox

Other: Computer game training (CG)

Maximal strength training (MST)

EXPERIMENTAL

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

Interventions

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.

Also known as: 4x4 interval
Aerobic interval training (AIT)

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.

Also known as: Tetris THQ Inc., Xbox, Microsoft
Computer game training (CG)

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.

Also known as: Leg press machine (Technogym), Olympic weights (Eleiko)
Maximal strength training (MST)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital, Department of Psychiatry

Trondheim, 7041, Norway

Location

Related 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.

MeSH Terms

Conditions

SchizophreniaCardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Study Officials

  • Geir Nilsberg, M.D.

    Norwegian University og Science and Technology

    STUDY CHAIR
  • Jørn Heggelund, M.Sc.

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2006

First Posted

February 3, 2006

Study Start

October 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations