An interventional study of endurance training and balance and tone program in Schizophrenia, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Other
Among 179 studies in Schizophrenia with a site in Germany — 17 open to participants now, 21 under way, none of them phase 3. Schizophrenia · Germany.
Among the 179 studies in Schizophrenia with a site in Germany, this one is the 57th largest by enrollment of the 155 interventional ones that give a count, is one of 10 that started in 2016, is one of 60 with no phase, and was the 137th registered.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
Browse Schizophrenia studies →17 of the 179 studies in Schizophrenia with a site in Germany are open now. Recruiting first, the newest first:
Stephanie Mehl · Sites in Germany
Charite University, Berlin, Germany · Sites in Germany
Charite University, Berlin, Germany · Sites in Germany
Hannover Medical School · Sites in Germany
Technical University of Munich · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
179 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 25 · Phase 3 36 · Phase 4 30
First in 2000; this study’s year is marked. 10 started in 2016.
This study's enrollment of 180 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Median enrollment 120 across the 155 interventional studies, 250 across the 22 observational. Of the 139 that completed or were terminated, 25 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
66 of 179 have an industry lead sponsor. The 10 most frequent:
Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Ludwig-Maximilians - University of Munich has 7 studies filed under Schizophrenia — fewer than ten, so there is no comparison to draw.
3 of the studies in Schizophrenia with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07265180Charite University, Berlin, GermanyOxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison | 2026-11-30 |
| NCT06740747Hannover Medical SchoolIntermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia | 2026-12-31 |
| NCT06456983Central Institute of Mental Health, MannheimMaintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial | 2027-07 |
Among the 179 studies in Schizophrenia with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The study investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia.
This multi-center, two-arm, parallel-group, randomized placebo-controlled add-on clinical trial investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia. The aim is the enhancement of recovery with the use of 26 weeks of continuos endurance training (aerobic exercise) with stationary bicycles or a balance and tone program consisting of exercises for flexibility, core strength, balance and relaxation. Followed by a follow-up period of 26 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
endurance training with stationary bicycles
Other: endurance training
flexibility, core strength, balance, relaxation
Other: balance and tone program
endurance training with stationary bicycles
Also known as: aerobic exercise
flexibility, core strength, balance, relaxation
all-cause discontinuation
Reason of study discontinuation will be identified. The all-cause-discontinuation questionnaire will be called up 9 times from baseline up to 12 months (compare time frame) including 26 weeks of intervention and 26 weeks follow up period. Reasons are defined as (1) relevant worsening of clinical symptoms (PANSS total score above 75 on cancerous visits for more than 14 days. (2) failure to take the prescribed medication for more than 14 days. (3) Failure to comply scheduled study or diagnostic appointments for more than 6 weeks (4) Patient unavailability despite extensive efforts of the treatment team (5) Withdrawal of patient consent (6) Clinician discontinuation.
Time frame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
improvement in neurocognition (VLMT)
As part of the measurement of cognitive performance during the screening phase and at the main measurement times (at baseline, day 98, day 182 and day 365), patients and control subjects will be tested using the Verbal Learning and Memory Test (VLMT).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in neurocognition (DSST)
As part of the measurement of cognitive performance during the screening phase and at the main measurement times (at baseline, day 98, day 182 and day 365), patients and control subjects will be tested using a test of verbal declarative episodic memory, the Digit Symbol Substitution Test (DSST).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in neurocognition (TMT)
As part of the measurement of cognitive performance during the screening phase and at the main measurement times (at baseline, day 98, day 182 and day 365), patients and control subjects will be tested using the Trail Making Test A and B (TMT) as a test of executive functions, quick visual comprehension, attention, and processing speed.
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in neurocognition (B-CATS)
The partial aspect of verbal fluid from the letter Cognitive Assessment Tool for Schizophrenia (B-CATS) is also used in the neuropsychological investigation at the main measurement times (at baseline, day 98, day 182 and day 365).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in neurocognition (MASC)
As part of the measurement of cognitive performance during the screening phase and at the main measurement times (at baseline, day 98, day 182 and day 365), patients and control subjects will be tested using the Facial Affect Recognition (AOP) and Theory of Mind methods. These are tasks using the Movie for the Assessment of Social Cognition (MASC).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in psychopathology (PANSS)
The assessment of psychopathology on the basis of a patient interview takes place at all main measurement times. At baseline, day 98, 182 and day 365. The PANSS uses a standard procedure for assessing schizophrenia symptoms, which measures the severity of individual symptoms as well as the various symptom subgroups of positive and negative symptoms and general psychopathology.
Time frame: 12 months (At baseline, day 98, 182 and day 365)
improvement in psychopathology (CGI)
The Clinical Global Impression Scale (CGI) assesses the overall symptom severity and response to interventions or therapies for psychiatric conditions to assess the effectiveness of the measures applied. It will be called up 9 times from baseline up to 12 months: At baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365.
Time frame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
improvement in psychopathology (SOFAS)
The Social and Occupational Functioning Assessment Scale (SOFAS) estimates social and professional performance. It will be called up 9 times from baseline up to 12 months: At baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365.
Time frame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
improvement in psychopathology (GAF)
The Social Assessment of Functioning Scale (GAF) also estimates social and professional performance. It takes place at all main measurement times. At baseline, day 98, 182 and day 365.
Time frame: 12 months (At baseline, day 98, 182 and day 365)
improvement in psychopathology (BSI-53)
The Brief Symptom Inventory (BSI-53) records the symptoms using 53 items. It takes place at all main measurement times. At baseline, day 98, 182 and day 365.
Time frame: 12 months (At baseline, day 98, 182 and day 365)
improvement in psychopathology (CDSS)
The Calgary Depression Scale for Schizophrenia (CDSS) measures suicidality and severity of depressive symptoms. It will be called up 9 times from baseline up to 12 months: At baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365.
Time frame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
improvement in social and occupational functioning (UPSA-B)
The University of California San Diego Performance-based Skills Assessment (UPSA-B) will be used to assess the day-to-day functioning of patients with schizophrenia in the household, communications, finance, transportation, and leisure activities role play situations. It takes place at all main measurement times. At baseline, day 98, 182 and day 365.
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in social and occupational functioning (FROGS)
Functional Remission of General Schizophrenia (FROGS) is used as a tool to measure changes in functional levels. It takes place at all main measurement times. At baseline, day 98, 182 and day 365.
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in social and occupational functioning (PSP)
The Personal and Social Performance Scale (PSP) is also a tool to measure changes in functional levels. It takes place at all main measurement times. At baseline, day 98, 182 and day 365.
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in quality of life
Only at the beginning and end of the intervention, and after one year, is the World Health Organization's Quality of Life Questionnaire (WHOQOL-Bref) used to record quality of life (The WHOQOL Group, 1998).
Time frame: 12 months (at baseline, day 182 and day 365)
improvement in body mass index (BMI)
Also, the body height (in meter) and weight (in kg) of the study participants are measured. Thereupon the BMI is calculated from the body weight (kg) divided by the square of the height (m2). The unit of BMI is kg / m2.
Time frame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
change of connectivity analysis (MRI of the brain)
At four time points, just prior to initiation of V1, V4, V6 after the end of the intervention and at V9 after the follow-up period of 6 months, structural and functional MRI (fMRI) examinations are performed on a 3 Tesla whole-body MR scanner in patients and healthy control subjects (Siemens) made. The findings are compared with data from healthy controls and non-diseased first-degree relatives of patients with schizophrenia who have been evaluated in other BMBF-funded studies ("MooDS", "IntegraMent"). In addition, cross-sectional comparisons (TAU + Exercise vs. TAU + BKGT) and progress measurements to characterize treatment effects are planned. The measurements are divided into 2 appointments to reduce the burden on patients and subjects by the measurement time.
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
change of volumes of brain regions (MRI)
First, structural measurements (T1 sequence, duration: approx. 5 minutes) and investigations of the fiber connections in the brain by means of diffusion-weighted imaging (DTI, duration: approx. 10 minutes) are carried out.
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
change of brain function (MRI)
By means of fMRI, the tasks resting activity, working memory, episodic memory, reward processing, social perspective takeover, emotion processing as well as ability to inhibit are to be investigated with already well pre-examined tasks. A function measurement is performed at rest without stimulation (rsMRT), which provides information on the functional networking of different brain regions at rest (duration: approx. 5 minutes). There are also three fMRI surveys that record brain activity during simple psychological tasks. - The ability to inhibit (prefrontal cortex, anterior cingulate gyrus) is examined by means of a so-called flanker task. This is to respond to a specific target stimulus, which is surrounded by either the same (congruent) or by distracting (incongruent) stimuli. - Duration: 11 minutes
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement of endurance capacity
As part of the sports medical stress test, the determination of endurance performance in patients and control subjects takes place. For this examination, like in training, finder bike use and measurements of heart rate, lactate concentration and exertion sensation are performed. The ergometry is carried out as a Vita maxima examination, so it ends when the subjects can not or do not want to keep pedaling or when the termination criteria according to Steinacker \& Liu (2002) occur. From the examination, various submaximal and maximal parameters can be determined, have the validity for endurance performance and the training intensity can be determined. The examination is carried out under standardized and safe conditions and after a detailed medical history and physical examination to exclude contraindications. Activity meters are used to control the physical activity of study participants outside the study intervention.
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
change of medication and attitude of the study participants to therapy (DAI)
Also, the attitude of the study participants to therapy and medication is recorded. For this, the Drug Attitude Inventory (DAI) is used. Is takes place at the main measurement times (at baseline, day 98, day 182 and day 365).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
change of medication and attitude of the study participants to therapy (SES)
The Service Engagement Scale (SES), which assesses accessibility, cooperation, help seeking and adherence, is used. It takes place at the main measurement times (at baseline, day 98, day 182 and day 365).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
improvement in metabolic parameters
The laboratory diagnostic measures include a laboratory blood test, with evaluation of blood lipid levels, the C-reactive protein, glycohemoglobin (HBA1c). It takes place at the main measurement times (at baseline, day 98, day 182 and day 365).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
urine (testing pregnancy and drug abuse)
Examination of the urine at baseline excludes pregnancy and drug abuse.
Time frame: baseline
gene expression
Investigation of gene expression takes place at baseline.
Time frame: baseline
change of genome-wide epigenetics
Investigation of genome-wide epigenetics takes place at the main measurement times (at baseline, day 98, day 182 and day 365).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
change of proteomics
Investigation of proteomics at the main measurement times (at baseline, day 98, day 182 and day 365).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
change of BDNF level
Investigation of BDNF levels at the main measurement times (at baseline, day 98, day 182 and day 365).
Time frame: 12 months (at baseline, day 98, day 182 and day 365)
Ran from Jun 2016 to primary completion in Dec 2021, 66 months.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 66 months is above that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Ludwig-Maximilians - University of Munich →