"InMotion" - Physical Training With Creative Movement as an Intervention for Adults With Schizophrenia

Schizophrenia and Related Disorders Clinical Trial

— InMotion  

Official title:

"InMotion" - Physical Training With Creative Movement as an Intervention for Adults With Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05673941
• Other study ID #: 278241
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

Other:
• Creative physical training
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.

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro
Sweden	Region Örebro county	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 minutes
Secondary	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.	2.5 minutes
Secondary	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.	2.5 minutes
Secondary	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.	10 minutes
Secondary	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.	10 minutes
Secondary	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.	10 minutes
Secondary	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.	5 minutes
Secondary	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.	5 minutes
Secondary	Physiological measures	Blood pressure measured by blood pressure monitor, resting heart rate, and breathing frequency	15 minutes
Secondary	Body measures	Weight, length, BMI and waistline will be measured	5 minutes
Secondary	Motion Capture	Movement of the participants will be recorded with the Qualisys Motion Capture device during the movement intervention	60 minutes
Secondary	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	45 minutes
Secondary	Postural stability test/balance	Measuring postural sway while person is standing on a forceplate	10 minutes
Secondary	Chair stand test	Chair stand test to measure strength in the legs	3 minutes
Secondary	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	7 days
Secondary	Blood samples	Blood samples including triglycerides, cholesterol, HDL, VLDL, HbA1, CRP, IL1b, IL6, TNFa, Hb, LPK, TPK, ASAT, ALAT, Natrium, Potassium and Creatinin	5 minutes
Secondary	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	60 minutes