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

This study has been completed.
Sponsor:
Collaborators:
St. Olavs Hospital
The Royal Norwegian Ministry of Health
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00286299
First received: February 2, 2006
Last updated: June 25, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Cardiovascular Disease
Other: Aerobic high-intensity interval training (AIT)
Other: Computer game training (CG)
Other: Maximal strength training
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physiological and Psychiatric Effects From Aerobic High Intensity Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia: A Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • peak aerobic capacity (VO2peak) [ Time Frame: Pre- and Posttest ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Pre- and Posttest ] [ Designated as safety issue: No ]
  • Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Pre- and Posttest ] [ Designated as safety issue: No ]
  • The 36-item short form (SF-36) [ Time Frame: Pre- and Posttest ] [ Designated as safety issue: No ]
  • 60 Watt walking efficiency, Net efficiency [ Time Frame: Pre- and Posttest ] [ Designated as safety issue: No ]
  • Maximal strength, measured as one repetition maximum (1RM) in a incline leg press machine (Technogym) [ Time Frame: Pre- and Post test ] [ Designated as safety issue: No ]
  • Fasting blood samples, systolic and diastolic blood pressure. [ Time Frame: Pre- and posttest ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: October 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic interval training (AIT)
Aerobic endurance training.
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 Name: 4x4 interval
Active Comparator: Computer game training (CG)
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 Name: Tetris THQ Inc., Xbox, Microsoft
Experimental: Maximal strength training 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)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286299

Locations
Norway
St. Olavs Hospital, Department of Psychiatry
Trondheim, Norway, 7041
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
The Royal Norwegian Ministry of Health
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
  More Information

Additional Information:
No publications provided

Responsible Party: Gunnar Morken, MD, PhD, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00286299     History of Changes
Other Study ID Numbers: 4.2005.1507
Study First Received: February 2, 2006
Last Updated: June 25, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Schizophrenia
Cardiovascular disease
Aerobic capacity
Mortality
Exercise

Additional relevant MeSH terms:
Cardiovascular Diseases
Schizophrenia
Stress, Psychological
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014