Treatment Effects From Aerobic Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia
This study has been completed.
Sponsor:
Norwegian University of Science and Technology
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
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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:
|
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 June 18, 2013