SchizophreniaEXERCISE-IINCT01776112
Enhancing Synaptic Plasticity and Cognition in Schizophrenia
A study testing Exercise and TableSoccer in people with Schizophrenia, run by University Medical Center Goettingen at 1 site in Germany.
Trial summary
To explore: (a) if physical exercise (sports) combined with cognitive training leads to (superior) improvement of cognition in schizophrenia compared to sports or cognitive training alone (b) if a sports program alone or in combination with cognitive training has influence on hippocampal pathology and synaptic… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Exercise and TableSoccer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Aug 2014
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female patients with the diagnosis of schizophrenia (based on ICD-10 criteria)
- Age between 18 and 55
- Verbal IQ ≥ 85
- Stable psychopathology on constant medication for 2 weeks
- Informed consent.
Who cannot join
- Patients, who are
- not willing or able to participate in the sports program and cognitive training
- reveal a significant worsening of psychopathology (based on an increase over 20% of the PANSS positive score)
- have an organic mental disorder (such as intoxication or neurological disorders of the CNS)
- suffer from instable somatic diseases
- have an active substance abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University
Göttingen, Lower Saxony, 37075
About this study
Official title: Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial
To explore: (a) if physical exercise (sports) combined with cognitive training leads to (superior) improvement of cognition in schizophrenia compared to sports or cognitive training alone (b) if a sports program alone or in combination with cognitive training has influence on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo condition.
- Conditions
- Schizophrenia
- Being tested
- Exercise, TableSoccer
- Keywords
- schizophrenia, negative symptoms, cognitive deficits, synaptic plasticity
- Medical subject headings
- Schizophrenia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.
TableSoccerOther
Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SZ-Exercise | Experimental | Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. Receives: Other: Exercise |
| SZ-TableSoccer | Placebo comparator | Standard treatment and participation in an activity without physical improvement as placebo condition (table soccer in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. Receives: Other: TableSoccer |
| HC-Exercise | Experimental | Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal volume
Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders
Measured: after three months of exercise
Secondary outcomes (2)
Verbal Learning Memory
Neuropsychological assessment of a working memory domain via the Verbal Learning Memory Test (German: Helmstaedter, C., Lendt, M., Lux, S., 2001. Verbaler Lern- und Merkfähigkeitstest (VLMT). Göttingen, Beltz)
Measured: after three months of exercise
Positive and negative symptoms
Measurement of positive and negative symptoms of schizophrenia using the "Positive and Negative Symptom Scale for Schizophrenia" (Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76)
Measured: after three months of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionMar 2014
- Study completionAug 2014
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Peter Falkai, University Medical Center Goettingen
- Investigators
- Peter Falkai, MD, PhD, Principal investigator, Head, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610Andrea Schmitt, MD, PhD, Study director, Professor, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610Berend Malchow, MD, Study director, Senior Consultant, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776112
- Sponsor's protocol ID
- UMCG-EX-II
- Acronym
- EXERCISE-II
- Status last verified
- May 2015
- First submitted
- 1 Jan 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193.
PubMed 20124113
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01776112
- Acronym / sponsor ID
- EXERCISE-II / UMCG-EX-II
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, negative symptoms, cognitive deficits, synaptic plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Jan 2013 (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.
To explore: (a) if physical exercise (sports) combined with cognitive training leads to (superior) improvement of cognition in schizophrenia compared to sports or cognitive training alone (b) if a sports program alone or in combination with cognitive training has influence on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SZ-Exercise | Experimental | Other: ExerciseStandard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. |
| SZ-TableSoccer | Placebo comparator | Other: TableSoccerStandard treatment and participation in an activity without physical improvement as placebo condition (table soccer in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. |
| HC-Exercise | Experimental | Other: ExerciseStandard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female patients with the diagnosis of schizophrenia (based on ICD-10 criteria)
- Age between 18 and 55
- Verbal IQ ≥ 85
- Stable psychopathology on constant medication for 2 weeks
- Informed consent.
Key exclusion criteria (6 listed)
- Patients, who are
- not willing or able to participate in the sports program and cognitive training
- reveal a significant worsening of psychopathology (based on an increase over 20% of the PANSS positive score)
- have an organic mental disorder (such as intoxication or neurological disorders of the CNS)
- suffer from instable somatic diseases
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 |
|---|---|---|
| ExerciseStandard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. | Other | HC-Exercise, SZ-Exercise |
| TableSoccerStandard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks. | Other | SZ-TableSoccer |
Primary outcome
Hippocampal volume
Time frame: after three months of exercise
Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders
2 secondary outcomes
Verbal Learning Memory
Time frame: after three months of exercise
Positive and negative symptoms
Time frame: after three months of exercise
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 27 May 2015.
- Background: PubMed 20124113Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193.
Related trials for Schizophrenia
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Recruiting
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Schizophrenia, Cerebellar Function
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Recruiting
tACS for Working Memory in Schizophrenia
Schizophrenia, Working Memory
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
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.
Peter Falkai, MD, PhD principal investigator
Head, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610
Andrea Schmitt, MD, PhD study director
Professor, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610
Berend Malchow, MD study director
Senior Consultant, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and TableSoccer in people with Schizophrenia, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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 27 May 2015. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Hippocampal volume (time frame: after three months of exercise). 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 NCT01776112, 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 27 May 2015; AzTrials last refreshed its copy on 30 Oct 2026.