Clinical trial NCT05673941: "InMotion" - Physical Training With Creative Movement as an Intervention for Adults With Schizophrenia
Official title: "InMotion" - Physical Training With Creative Movement as an Intervention for Adults With Schizophrenia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia and Related Disorders
Keywords: Schizophrenia
Physical activity
Randomized trial
EEG
fNIRS
Motion capture
Dance
Creative movement
Physical Training
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Schizophrenia diagnosis or schizophrenia similar condition, age 18-65 years, performing physical activity less than 150 min/week.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 45 minutes
Secondary outcomes:
measure: Clinical Global Impression - Severity scale (CGI-S)
timeFrame: 2.5 minutes
measure: Clinical Global Impression - Improvement scale (CGI-I)
timeFrame: 2.5 minutes
measure: The Calgary Depression Scale for Schizophrenics (CDSS)
timeFrame: 10 minutes
measure: Body Awareness Questionnaire (BAQ-sv)
timeFrame: 10 minutes
measure: The personal and social performance scale (PSP)
timeFrame: 10 minutes
measure: EQ-5D-5L
timeFrame: 5 minutes
measure: Burden of Care - Visual Analogue Scale
timeFrame: 5 minutes
measure: Physiological measures
timeFrame: 15 minutes
measure: Body measures
timeFrame: 5 minutes
measure: Motion Capture
timeFrame: 60 minutes
measure: fNIRS, EEG, and eye-tracking
timeFrame: 45 minutes
measure: Postural stability test/balance
timeFrame: 10 minutes
measure: Chair stand test
timeFrame: 3 minutes
measure: Everyday activity
timeFrame: 7 days
measure: Blood samples
timeFrame: 5 minutes
measure: Interviews
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Region Örebro county
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: Mats Eriksson, Professor
role: PRINCIPAL_INVESTIGATOR
References: