Schizophrenia and Related DisordersInMotionNCT05673941
"InMotion" - Physical Training With Creative Movement as an Intervention for Adults With Schizophrenia
A study testing Creative physical training in people with Schizophrenia and Related Disorders, run by Örebro University, Sweden at 2 sites in Sweden.
Trial summary
InMotion is a randomized controlled study where adults with schizophrenia and schizophrenia-similar conditions, will be recruited to receive physical training with creative movements as an intervention, twice a week for a period of 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia and Related Disorders
- What is being tested?
- Creative physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Sep 2022to 31 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia diagnosis or schizophrenia similar condition, age 18-65 years, performing physical activity less than 150 min/week.
Who cannot join
- Current or recent history of substance abuse, bipolar disorder, severe autism, suicidal, severe physical illness, inability to read and understand the Swedish language and inability to interact with other people in a group.
Trial locations and contacts
2 sites in 1 country.
About this study
InMotion is a randomized controlled study where adults with schizophrenia and schizophrenia-similar conditions, will be recruited to receive physical training with creative movements as an intervention, twice a week for a period of 12 weeks. The main outcome is changes in schizophrenia-related symptoms, secondary outcomes are changes in quality of life, physical and cognitive function, brain activity, and how the intervention is experienced by the participants.
Read the detailed description
Schizophrenia (SCZ) is among the world's top ten causes of long-term disability (World Health Organization, 2004). The major symptoms of SCZ include hallucinations, delusions, affective flattening, apathy and cognitive impairment. These symptoms lead to major problems in social and occupational functioning, and in self-care.
Our primary aim is to investigate the effects of 12-weeks of physical training with creative movement as an intervention given in addition to ongoing pharmacological treatment, in treating SCZ-symptoms compared to a control group. Secondary aim is to provide results regarding the effects of the intervention on (a) clinical symptom measures and quality of life, (b) levels of physical activity, physical function and measures of general health indicators, (a) clinical symptom measures and quality of life, (b) levels of physical activity, physical function and measures of general health indicators, (c) error detection and conflict resolution on the prefrontal cortex, memory and context processing (d) fluency of speak, and (e) emotional induction and regulation on specific emotions on the frontal cortex. Trough qualitative interviews, we will examine the participants' and their relative parties' experiences from taking part of the intervention and eventual experienced effects from it.
This study, called InMotion, is a prospective randomized controlled trial where the study participants will be randomized to 12-weeks of physical training with creative movement as an intervention in addition to standard care (intervention group) or to standard care alone (control group). The target group consists of adults with SCZ or SCZ-similar condition.
The intervention consists of organized training sessions in group, 2 times a week. The control group receives standard medical care and gets access to the intervention in digital form after the study has ended. The outcomes are measured at baseline, after 6 and 12 weeks, 6 months and 12 months. At all follow-ups, data are collected for both the intervention and control groups. The trial is being conducted in Örebro, Sweden. The study follows the standard methodology of intervention research.
60 patients with SCZ will be recruited continuously by staff at the psychiatry at the university hospital in Örebro. When matched to inclusion and exclusion criteria, written and informed consent will be obtained from all participants willing to participate. 30 patients will be randomized to participate in creative physical training in addition to continuing their conventional treatment plan (SCZ-I group) and 30 patients will be randomized to control group and receive treatment as usual (SCZ-C). Randomization to SCZ-I and SCZ-C groups will be done by sealed envelopes given to the participants after baseline measures.
The intervention covers various themes through three different parts (4 weeks per part). The intervention was developed by a team consisting of physiotherapists, dance teachers, a neuroscientist and a psychiatrist, with the aim to improve clinical symptoms, physical fitness, cognitive skills and emotion regulations. The intervention is further described in Table 1. The exercise is partly accompanied with calm music and recorded nature sounds and partly made in silence listening to one's own bodily rhythm. The exercise consists of tasks related to cardio and strength training, balance, conscious breathing, body awareness, mental imagery (nature visualizations), flexibility, emotional expression, and movement anticipation together with the facilitator and fellow participants. All the tasks are practiced during a flow of 45- to 60-minute exercise without any major breaks. Complexity and physical intensity of the tasks will gradually increase over the 12-week intervention period.
The duration of the biweekly creative movement intervention will be from 45 minutes (week 1 and 2) to 60 minutes (week 3-12), the order and content of which is described in detail in Table 1. Throughout the intervention period, the participants will be encouraged to practice their favorite movements or relaxation techniques at home if they want to. The participants will get recordings of the sessions from the intervention coordinators in the research team, if they want to have support in practicing on their own at home. If a participant misses a session, they will get a text-message and an email with the video again, and encouragement to practice at home to keep up the frequency of two sessions a week, and the instructor will ask them if they have done so to ensure that it is important and relevant with regularity.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- Creative physical training
- Keywords
- Schizophrenia, Physical activity, Randomized trial, EEG, fNIRS, Motion capture, Dance, Creative movement, Physical Training
- Medical subject headings
- Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creative physical trainingOther
The intervention will be performed as a group activity twice a week during a 12-week period. Each group will include 4-6 participants under the guidance of two instructors, and a related party if needed or wanted from the participant. The exercise is partly accompanied with calm music and recorded nature sounds and partly made in silence listening to one's own bodily rhythm. The exercise consists of tasks related to cardio and strength training, balance, conscious breathing, body awareness, mental imagery (nature visualizations), flexibility, emotional expression, and movement anticipation together with the facilitator and fellow participants. All the tasks are practiced during a flow of 45- to 60-minute exercise without any major breaks. Complexity and physical intensity of the tasks will gradually increase over the 12-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Creative movement | Experimental | The intervention will be performed as a group activity twice a week during a 12-week period. Each group will include 4-6 participants under the guidance of two instructors, and a related party if needed or wanted from the participant. The exercise is partly accompanied with calm music and recorded nature sounds and partly made in silence listening to one's own bodily rhythm. The exercise consists of tasks related to cardio and strength training, balance, conscious breathing, body awareness, mental imagery (nature visualizations), flexibility, emotional expression, and movement anticipation together with the facilitator and fellow participants. All the tasks are practiced during a flow of 45- to 60-minute exercise without any major breaks. Complexity and physical intensity of the tasks will gradually increase over the 12-week intervention period. Receives: Other: Creative physical training |
| Control group | No intervention | The control group receives standard medical care and gets access to the intervention in digital form after the study has ended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
The Positive and Negative Syndrome Scale (PANSS) is an established psychiatric rating system that is an operationalized, drug-sensitive instrument that offers balanced representation of positive and negative symptoms and estimates their relationship to one another and to global (or general) psychopathology.
Measured: 45 minutes
Secondary outcomes (16)
Clinical Global Impression - Severity scale (CGI-S)
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Measured: 2.5 minutes
Clinical Global Impression - Improvement scale (CGI-I)
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: 2.5 minutes
The Calgary Depression Scale for Schizophrenics (CDSS)
The Calgary Depression Scale for Schizophrenia (CDSS) is a nine item clinician rated outcome measure that assesses the level of depression in people with schizophrenia.
Measured: 10 minutes
Body Awareness Questionnaire (BAQ-sv)
Body Awareness Questionnaire includes 18 suggestions of four subgroups (changes in the body process, sleep-wake cycle, estimation of disease onset, and estimation of body reactions) and aims to determine the level of body awareness.
Measured: 10 minutes
The personal and social performance scale (PSP)
The Personal Social Performance scale assesses socially useful activities, personal and social relationships, self-care and disturbing and aggressive behaviours.
Measured: 10 minutes
EQ-5D-5L
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: 5 minutes
Burden of Care - Visual Analogue Scale
Burden of Care is rated on a Visual Analogue Scale by a significant other, measuring the expressed burden in relation to the patient, the last month.
Measured: 5 minutes
Physiological measures
Blood pressure measured by blood pressure monitor, resting heart rate, and breathing frequency
Measured: 15 minutes
Body measures
Weight, length, BMI and waistline will be measured
Measured: 5 minutes
Motion Capture
Movement of the participants will be recorded with the Qualisys Motion Capture device during the movement intervention
Measured: 60 minutes
fNIRS, EEG, and eye-tracking
Cortical activity and eye movements will be measured from the patients with a combined EEG-fNIRS cap and eye-tracking glasses in stillness (baseline brain activity) and when doing conventional tasks measuring cognitive skills, emotion regulation and movement imitation
Measured: 45 minutes
Postural stability test/balance
Measuring postural sway while person is standing on a forceplate
Measured: 10 minutes
Chair stand test
Chair stand test to measure strength in the legs
Measured: 3 minutes
Everyday activity
Everyday activity is measured by an accelerometer which the participants will carry with them for seven days in a row to collect the amount of time spent sedentary, and active, and the intensity of the activity
Measured: 7 days
Blood samples
Blood samples including triglycerides, cholesterol, HDL, VLDL, HbA1, CRP, IL1b, IL6, TNFa, Hb, LPK, TPK, ASAT, ALAT, Natrium, Potassium and Creatinin
Measured: 5 minutes
Interviews
Qualitative semistructured interviews with 15-20 persons after the intervention. Both participants and related parties get to share their experience of the intervention as well as eventual effects from it
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Schizophrenia and Related DisordersStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mats Eriksson, Professor, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673941
- Sponsor's protocol ID
- 278241
- Acronym
- InMotion
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poikonen H, Duberg A, Eriksson M, Eriksson-Crommert M, Lund M, Moller M, Msghina M. "InMotion"-Mixed physical exercise program with creative movement as an intervention for adults with schizophrenia: study protocol for a randomized controlled trial. Front Hum Neurosci. 2023 Jul 5;17:1192729. doi: 10.3389/fnhum.2023.1192729. eCollection 2023.
PubMed 37476005
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "InMotion" - Physical Training With Creative Movement as an Intervention for Adults With Schizophrenia
- ClinicalTrials.gov ID
- NCT05673941
- Acronym / sponsor ID
- InMotion / 278241
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- Schizophrenia, Physical activity, Randomized trial, EEG, fNIRS, Motion capture, Dance, Creative movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jan 2023 (actual)
- 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.
InMotion is a randomized controlled study where adults with schizophrenia and schizophrenia-similar conditions, will be recruited to receive physical training with creative movements as an intervention, twice a week for a period of 12 weeks. The main outcome is changes in schizophrenia-related symptoms, secondary outcomes are changes in quality of life, physical and cognitive function, brain activity, and how the intervention is experienced by the participants.
Detailed description
Schizophrenia (SCZ) is among the world's top ten causes of long-term disability (World Health Organization, 2004). The major symptoms of SCZ include hallucinations, delusions, affective flattening, apathy and cognitive impairment. These symptoms lead to major problems in social and occupational functioning, and in self-care.
Our primary aim is to investigate the effects of 12-weeks of physical training with creative movement as an intervention given in addition to ongoing pharmacological treatment, in treating SCZ-symptoms compared to a control group. Secondary aim is to provide results regarding the effects of the intervention on (a) clinical symptom measures and quality of life, (b) levels of physical activity, physical function and measures of general health indicators, (a) clinical symptom measures and quality of life, (b) levels of physical activity, physical function and measures of general health indicators, (c) error detection and conflict resolution on the prefrontal cortex, memory and context processing (d) fluency of speak, and (e) emotional induction and regulation on specific emotions on the frontal cortex. Trough qualitative interviews, we will examine the participants' and their relative parties' experiences from taking part of the intervention and eventual experienced effects from it.
This study, called InMotion, is a prospective randomized controlled trial where the study participants will be randomized to 12-weeks of physical training with creative movement as an intervention in addition to standard care (intervention group) or to standard care alone (control group). The target group consists of adults with SCZ or SCZ-similar condition.
The intervention consists of organized training sessions in group, 2 times a week. The control group receives standard medical care and gets access to the intervention in digital form after the study has ended. The outcomes are measured at baseline, after 6 and 12 weeks, 6 months and 12 months. At all follow-ups, data are collected for both the intervention and control groups. The trial is being conducted in Örebro, Sweden. The study follows the standard methodology of intervention research.
60 patients with SCZ will be recruited continuously by staff at the psychiatry at the university hospital in Örebro. When matched to inclusion and exclusion criteria, written and informed consent will be obtained from all participants willing to participate. 30 patients will be randomized to participate in creative physical training in addition to continuing their conventional treatment plan (SCZ-I group) and 30 patients will be randomized to control group and receive treatment as usual (SCZ-C). Randomization to SCZ-I and SCZ-C groups will be done by sealed envelopes given to the participants after baseline measures.
The intervention covers various themes through three different parts (4 weeks per part). The intervention was developed by a team consisting of physiotherapists, dance teachers, a neuroscientist and a psychiatrist, with the aim to improve clinical symptoms, physical fitness, cognitive skills and emotion regulations. The intervention is further described in Table 1. The exercise is partly accompanied with calm music and recorded nature sounds and partly made in silence listening to one's own bodily rhythm. The exercise consists of tasks related to cardio and strength training, balance, conscious breathing, body awareness, mental imagery (nature visualizations), flexibility, emotional expression, and movement anticipation together with the facilitator and fellow participants. All the tasks are practiced during a flow of 45- to 60-minute exercise without any major breaks. Complexity and physical intensity of the tasks will gradually increase over the 12-week intervention period.
The duration of the biweekly creative movement intervention will be from 45 minutes (week 1 and 2) to 60 minutes (week 3-12), the order and content of which is described in detail in Table 1. Throughout the intervention period, the participants will be encouraged to practice their favorite movements or relaxation techniques at home if they want to. The participants will get recordings of the sessions from the intervention coordinators in the research team, if they want to have support in practicing on their own at home. If a participant misses a session, they will get a text-message and an email with the video again, and encouragement to practice at home to keep up the frequency of two sessions a week, and the instructor will ask them if they have done so to ensure that it is important and relevant with regularity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creative movement | Experimental | Other: Creative physical trainingThe intervention will be performed as a group activity twice a week during a 12-week period. Each group will include 4-6 participants under the guidance of two instructors, and a related party if needed or wanted from the participant. The exercise is partly accompanied with calm music and recorded nature sounds and partly made in silence listening to one's own bodily rhythm. The exercise consists of tasks related to cardio and strength training, balance, conscious breathing, body awareness, mental imagery (nature visualizations), flexibility, emotional expression, and movement anticipation together with the facilitator and fellow participants. All the tasks are practiced during a flow of 45- to 60-minute exercise without any major breaks. Complexity and physical intensity of the tasks will gradually increase over the 12-week intervention period. |
| Control group | No intervention | –The control group receives standard medical care and gets access to the intervention in digital form after the study has ended. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Schizophrenia diagnosis or schizophrenia similar condition, age 18-65 years, performing physical activity less than 150 min/week.
Key exclusion criteria (1 listed)
- Current or recent history of substance abuse, bipolar disorder, severe autism, suicidal, severe physical illness, inability to read and understand the Swedish language and inability to interact with other people in a group.
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 |
|---|---|---|
| Creative physical trainingThe intervention will be performed as a group activity twice a week during a 12-week period. Each group will include 4-6 participants under the guidance of two instructors, and a related party if needed or wanted from the participant. The exercise is partly accompanied with calm music and recorded nature sounds and partly made in silence listening to one's own bodily rhythm. The exercise consists of tasks related to cardio and strength training, balance, conscious breathing, body awareness, mental imagery (nature visualizations), flexibility, emotional expression, and movement anticipation together with the facilitator and fellow participants. All the tasks are practiced during a flow of 45- to 60-minute exercise without any major breaks. Complexity and physical intensity of the tasks will gradually increase over the 12-week intervention period. | Other | Creative movement |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: 45 minutes
The Positive and Negative Syndrome Scale (PANSS) is an established psychiatric rating system that is an operationalized, drug-sensitive instrument that offers balanced representation of positive and negative symptoms and estimates their relationship to one another and to global (or general) psychopathology.
16 secondary outcomes
Clinical Global Impression - Severity scale (CGI-S)
Time frame: 2.5 minutes
Clinical Global Impression - Improvement scale (CGI-I)
Time frame: 2.5 minutes
The Calgary Depression Scale for Schizophrenics (CDSS)
Time frame: 10 minutes
Body Awareness Questionnaire (BAQ-sv)
Time frame: 10 minutes
The personal and social performance scale (PSP)
Time frame: 10 minutes
EQ-5D-5L
Time frame: 5 minutes
Burden of Care - Visual Analogue Scale
Time frame: 5 minutes
Physiological measures
Time frame: 15 minutes
Body measures
Time frame: 5 minutes
Motion Capture
Time frame: 60 minutes
fNIRS, EEG, and eye-tracking
Time frame: 45 minutes
Postural stability test/balance
Time frame: 10 minutes
Chair stand test
Time frame: 3 minutes
Everyday activity
Time frame: 7 days
Blood samples
Time frame: 5 minutes
Interviews
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 37476005Poikonen H, Duberg A, Eriksson M, Eriksson-Crommert M, Lund M, Moller M, Msghina M. "InMotion"-Mixed physical exercise program with creative movement as an intervention for adults with schizophrenia: study protocol for a randomized controlled trial. Front Hum Neurosci. 2023 Jul 5;17:1192729. doi: 10.3389/fnhum.2023.1192729. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Mats Eriksson, Professor principal investigator
Örebro University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creative physical training in people with Schizophrenia and Related Disorders, run by Örebro University, Sweden at 2 sites in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Results are not available in the source record.
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?
Positive and Negative Syndrome Scale (PANSS) (time frame: 45 minutes). 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 NCT05673941, 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 6 Jan 2023.