Back to resultsTreatment Effects From Aerobic Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia
Primary Purpose
Schizophrenia, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Aerobic high-intensity interval training (AIT)
Computer game training (CG)
Maximal strength training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cardiovascular disease, Aerobic capacity, Mortality, Exercise
Eligibility 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.
Sites / Locations
- St. Olavs Hospital, Department of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Aerobic interval training (AIT)
Computer game training (CG)
Maximal strength training (MST)
Arm Description
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.
36 minutes playing supervised computer games, Tetris, Xbox
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.
Outcomes
Primary Outcome Measures
peak aerobic capacity (VO2peak)
Secondary Outcome Measures
Positive and Negative Syndrome Scale (PANSS)
Calgary Depression Scale for Schizophrenia (CDSS)
The 36-item short form (SF-36)
60 Watt walking efficiency, Net efficiency
Maximal strength, measured as one repetition maximum (1RM) in a incline leg press machine (Technogym)
Fasting blood samples, systolic and diastolic blood pressure.
Full Information
NCT ID
NCT00286299
First Posted
February 2, 2006
Last Updated
March 28, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Nord-Trøndelag HF
1. Study Identification
Unique Protocol Identification Number
NCT00286299
Brief Title
Treatment Effects From Aerobic Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2005 (Actual)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Helse Nord-Trøndelag HF
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cardiovascular Disease
Keywords
Schizophrenia, Cardiovascular disease, Aerobic capacity, Mortality, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic interval training (AIT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Computer game training (CG)
Arm Type
Active Comparator
Arm Description
36 minutes playing supervised computer games, Tetris, Xbox
Arm Title
Maximal strength training (MST)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic high-intensity interval training (AIT)
Other Intervention Name(s)
4x4 interval
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Computer game training (CG)
Other Intervention Name(s)
Tetris THQ Inc., Xbox, Microsoft
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Maximal strength training
Other Intervention Name(s)
Leg press machine (Technogym), Olympic weights (Eleiko)
Intervention Description
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.
Primary Outcome Measure Information:
Title
peak aerobic capacity (VO2peak)
Time Frame
Pre- and Posttest
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
Pre- and Posttest
Title
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
Pre- and Posttest
Title
The 36-item short form (SF-36)
Time Frame
Pre- and Posttest
Title
60 Watt walking efficiency, Net efficiency
Time Frame
Pre- and Posttest
Title
Maximal strength, measured as one repetition maximum (1RM) in a incline leg press machine (Technogym)
Time Frame
Pre- and Post test
Title
Fasting blood samples, systolic and diastolic blood pressure.
Time Frame
Pre- and posttest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Nilsberg, M.D.
Organizational Affiliation
Norwegian University og Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jørn Heggelund, M.Sc.
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Olavs Hospital, Department of Psychiatry
City
Trondheim
ZIP/Postal Code
7041
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21332297
Citation
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.
Results Reference
result
Learn more about this trial
Treatment Effects From Aerobic Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia
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