SchizophreniaNCT00286299
Treatment Effects From Aerobic Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia
A study testing Aerobic high-intensity interval training (AIT), Computer game training (CG) and Maximal strength training in people with Schizophrenia and Cardiovascular Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia, Cardiovascular Disease
- What is being tested?
- Aerobic high-intensity interval training (AIT), Computer game training (CG) and Maximal strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2005to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Schizophrenia, Cardiovascular Disease
- Being tested
- Aerobic high-intensity interval training (AIT), Computer game training (CG), Maximal strength training
- Keywords
- Schizophrenia, Cardiovascular disease, Aerobic capacity, Mortality, Exercise
- Medical subject headings
- Schizophrenia, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic high-intensity interval training (AIT)Other
Also called 4x4 interval
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)Other
Also called Tetris THQ Inc., Xbox, Microsoft
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 trainingOther
Also called Leg press machine (Technogym), Olympic weights (Eleiko)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Aerobic high-intensity interval training (AIT) |
| Computer game training (CG) | Active comparator | 36 minutes playing supervised computer games, Tetris, Xbox Receives: 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. Receives: Other: Maximal strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak aerobic capacity (VO2peak)
Measured: Pre- and Posttest
Secondary outcomes (6)
Positive and Negative Syndrome Scale (PANSS)
Measured: Pre- and Posttest
Calgary Depression Scale for Schizophrenia (CDSS)
Measured: Pre- and Posttest
The 36-item short form (SF-36)
Measured: Pre- and Posttest
60 Watt walking efficiency, Net efficiency
Measured: Pre- and Posttest
Maximal strength, measured as one repetition maximum (1RM) in a incline leg press machine (Technogym)
Measured: Pre- and Post test
Fasting blood samples, systolic and diastolic blood pressure.
Measured: Pre- and posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startOct 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Geir Nilsberg, M.D., Study chair, Norwegian University og Science and TechnologyJørn Heggelund, M.Sc., Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286299
- Sponsor's protocol ID
- 4.2005.1507
- Status last verified
- Mar 2017
- First submitted
- 2 Feb 2006
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21332297
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00286299
- Acronym / sponsor ID
- 4.2005.1507
- Conditions
- Schizophrenia, Cardiovascular Disease
- Keywords
- Schizophrenia, Cardiovascular disease, Aerobic capacity, Mortality, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Study start
- Oct 2005 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic interval training (AIT) | Experimental | Other: Aerobic high-intensity interval training (AIT)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. |
| Computer game training (CG) | Active comparator | Other: Computer game training (CG)36 minutes playing supervised computer games, Tetris, Xbox |
| Maximal strength training (MST) | Experimental | Other: Maximal strength trainingMST 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic high-intensity interval training (AIT)Also: 4x4 intervalThe 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 | Aerobic interval training (AIT) |
| Computer game training (CG)Also: Tetris THQ Inc., Xbox, MicrosoftThe 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 | Computer game training (CG) |
| Maximal strength trainingAlso: Leg press machine (Technogym), Olympic weights (Eleiko)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 | Maximal strength training (MST) |
Primary outcome
peak aerobic capacity (VO2peak)
Time frame: Pre- and Posttest
6 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: Pre- and Posttest
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Pre- and Posttest
The 36-item short form (SF-36)
Time frame: Pre- and Posttest
60 Watt walking efficiency, Net efficiency
Time frame: Pre- and Posttest
Maximal strength, measured as one repetition maximum (1RM) in a incline leg press machine (Technogym)
Time frame: Pre- and Post test
Fasting blood samples, systolic and diastolic blood pressure.
Time frame: Pre- and posttest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Results publication: PubMed 21332297Heggelund 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir Nilsberg, M.D. study chair
Norwegian University og Science and Technology
Jørn Heggelund, M.Sc. principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic high-intensity interval training (AIT), Computer game training (CG) and Maximal strength training in people with Schizophrenia and Cardiovascular Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak aerobic capacity (VO2peak) (time frame: Pre- and Posttest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00286299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.