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

• ClinicalTrials.gov Identifier: NCT00286299
• Recruitment Status: Completed
• First Posted: February 3, 2006
• Last Update Posted: March 29, 2017
• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Central Norway Regional Health Authority
• Information provided by (Responsible Party): Norwegian University of Science and Technology

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Cardiovascular Disease	Other: Aerobic high-intensity interval training (AIT); Other: Computer game training (CG); Other: Maximal strength training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Actual Study Start Date: October 2005
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aerobic 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.	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); 36 minutes playing supervised computer games, 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 (MST); 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; 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)

Outcome Measures

Primary Outcome Measures :

1. peak aerobic capacity (VO2peak) [ Time Frame: Pre- and Posttest ]

Secondary Outcome Measures :

1. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Pre- and Posttest ]
2. Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Pre- and Posttest ]
3. The 36-item short form (SF-36) [ Time Frame: Pre- and Posttest ]
4. 60 Watt walking efficiency, Net efficiency [ Time Frame: Pre- and Posttest ]
5. Maximal strength, measured as one repetition maximum (1RM) in a incline leg press machine (Technogym) [ Time Frame: Pre- and Post test ]
6. Fasting blood samples, systolic and diastolic blood pressure. [ Time Frame: Pre- and posttest ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Norway

St. Olavs Hospital, Department of Psychiatry

Trondheim, Norway, 7041

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

Central Norway Regional Health Authority

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:

AFFU - Mental Health Care, Department of Research and Development, St. Olavs University Hospital, Trondheim, Norway 

Publications of Results:

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.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT00286299
• Other Study ID Numbers: 4.2005.1507
• First Posted: February 3, 2006
• Last Update Posted: March 29, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:

Schizophrenia; Cardiovascular disease; Aerobic capacity; Mortality; Exercise

Additional relevant MeSH terms:

Cardiovascular Diseases; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders