NCT05673941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 6, 2023

Status Verified

December 1, 2022

Enrollment Period

2.3 years

First QC Date

December 30, 2022

Last Update Submit

December 30, 2022

Conditions

Keywords

SchizophreniaPhysical activityRandomized trialEEGfNIRSMotion captureDanceCreative movementPhysical Training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Clinical Global Impression - Severity scale (CGI-S)

    2.5 minutes

  • Clinical Global Impression - Improvement scale (CGI-I)

    2.5 minutes

  • The Calgary Depression Scale for Schizophrenics (CDSS)

    10 minutes

  • Body Awareness Questionnaire (BAQ-sv)

    10 minutes

  • The personal and social performance scale (PSP)

    10 minutes

  • +11 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Creative movement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Region Örebro county

Örebro, S-70185, Sweden

Location

Örebro University

Örebro, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SchizophreniaMotor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Study Officials

  • Mats Eriksson, Professor

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will be pseudonymized by using a study code. The researchers will be blind to group allocation when analyzing data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 6, 2023

Study Start

September 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

January 6, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations