Braining - Physical Exercise in Psychiatry - Evaluation of Feasibility, and Health Among Patients

Mental Disorder Clinical Trial

Official title: Braining Study - Implementation of Physical Activity for Patients and Staff in Specialist Psychiatry, Feasibility on Pilot Unit and Effect Evaluation in Randomized Controlled Multi-center Study.

Status Completed

Clinical Trial Summary

Physical exercise (PE) shows beneficial effects on somatic and psychiatric symptoms. "Braining" is a clinical invention where psychiatric staff exercise together with patients to help patients start and execute PE regularly. In the present study the feasibility of the intervention will be evaluated, how Braining is perceived, and preliminary effects on health and physical activity among patients. The investigators hypothesize that patients' health and physical activity will increase after participation in Braining at the unit. Braining will be implemented at two psychiatric pilot units in Region Stockholm, Sweden. During 6 months patients will be included and treated in 12 weeks PE intervention periods. To measure feasibility patients will answer self-rating questionnaires and be invited to semi structured interviews after receiving the intervention. Health will be measured by physical examination and blood test as well as self-ratings of depression, anxiety, sleep, hypomania, and quality of life before the intervention, every 4 weeks during the intervention, post the intervention, and at follow-up 12 months post the intervention. Physical activity will be rated before, during, after the intervention and at follow-up 12 months post the intervention using International Physical Activity Questionnaires (IPAQ) and Actigraph. All patients that fulfill inclusion criteria at the units will be invited to participate in the study, approximately 50 individuals in total.

Clinical Trial Description

"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic moderate to vigorous aerobic group training sessions and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan. Braining is unique in that it:

1. Includes trained psychiatric clinical staff exercising together with patients from both out- and inpatient ward units in daily, moderate to vigorous aerobic group training sessions

2. is included in regular healthcare fee, (free of charge)

3. includes a motivational and educational visit (as a group seminar or as an individual visit) at the start and end of a twelve-week exercise intervention

4. includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve-week exercise intervention)

5. offers short individual motivating visits before every training session, including assessment of day shape and fitness to participate.

In the present study focus is on the feasibility of the intervention, how Braining is perceived, and preliminary effects on health and physical activity among patients. The research questions are:

1. How do patients experience Braining in regards such as feasibility, acceptability, credibility, and effects on health and quality of life?

2. How do patients comply to Braining regarding completed training sessions and measurements?

3. What preliminary effect does Braining have on mental and physical health, quality of life and level of function in participating patients before compared to after short- and long-term exposure?

Examined from the following points of view:

• psychiatric symptoms, such as depression, hypomania, anxiety, insomnia?

• Somatic symptoms, such as blood pressure, resting heart rate, BMI, waist circumference, occurrence of somatic co-morbidity? Braining is to be implemented at 2 psychiatric care units starting nov 2021. Approximately 50 patients will be included. Planned design is an open trial study with monthly measurements during ongoing intervention (weeks 1, 4, 8 and 12) and one follow-up (12 months post inclusion). Physical activity level is measured with Actigraph and IPAQ 1 week before, 6 weeks in, after the intervention and at follow up.

Patients´ experience of Braining is examined with self-assessments and in interviews after the end of the intervention. Data analysis Qualitative analysis: Recorded material from interviews is transcribed and analyzed based on the thematic analysis method according to Braun & Clarke et al 2006). The method aims to understand the individual's perspective in relation to a particular phenomenon and is often used as an inductive hypothesis-generating approach. Continuous data will be analyzed using mixed effects models or t-test, nominal data analyzed mainly with chi2 test. In mixed effects models of differences between groups the interaction effect of group and time will be the central estimate. ;

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Psychotic Disorders

• NCT number: NCT05186688
• Study type: Interventional
• Source: Region Stockholm
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Completion date: September 30, 2023