Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry

Mental Disorders Clinical Trial

Official title: Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry, Efficacy Evaluation in a Randomized Controlled Multicentre Trial

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to compare Braining, a physical exercise lifestyle intervention in psychiatric care, with structured advice on physical exercise.

The main questions are:

• does Braining lead to increased physical exercise compared to structured advice on physical exercise?

• what effect does Braining have on mental and physical health, quality of life and functional level compared to structured advice on physical exercise?

The participants will join a twelve weeks long study period with clinician led exercise classes up to three times per week. Before and after the study period they will leave blood tests, take part in a mental and physical examination and fill in assessment scales. To measure physical activity, the participants will carry an accelerometer, a device that measures steps and acceleration. After six and twelve months, the participants take part in the same measurements.

The control group takes parts in the same measurements and follow up, but instead of having clinician led exercise classes, they will exercise on their own during the twelve weeks study period.

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.

This study will be a multi-center study performed at 5 psychiatric outpatient units in Region Stockholm. Patients with symptoms of depression and/or anxiety who are not physically active in accordance with WHO recommendations will be invited to participate in the study.

The research questions are:

• Does Braining increase the amount of completed physical training (PT) compared to structured advice on physical exercise (advice on PT according to guidelines)?

• What effect does Braining have on the mental and physical health, quality of life and functional level of participating patients compared to structured advice on physical exercise? Examined from the following points of view:

• psychiatric symptoms, such as depression, anxiety, insomnia, emotional regulation?

• somatic symptoms, such as blood pressure, resting heart rate, BMI, waist measurement, presence of somatic co-morbidity?

• How do participants rate Braining and structured advice on physical exercise regarding:

1. Satisfaction with treatment

2. Credibility of treatment

3. Negative effects

• Is Braining a cost-effective intervention?

Participants will be randomized to supplementary treatment with Braining or structured advice on physical activity.

Braining and advice on physical activity will be compared after a 12-week training period.

Measurements of the participants´ psychiatric and somatic health are carried out before the treatment, after 4, 8 and 12 weeks and 6 and 12 months after the end of treatment. Effects of the treatment are examined via validated self-assessment forms, as well as somatic examination with a focus on metabolic status. Venous blood samples are taken before and after the 12-week training period, as well as 6 and 12 months after the end of the training period to investigate changes in metabolic status. In a sub study on a smaller number of participants the researchers will analyze associations with biological factors such as genetic or epigenetic factors, metabolic factors, stress hormone levels, trace elements, degree of inflammation and other biological markers of health and disease that can be measured in ordinary blood tests, e.g. through "Omik" design. Physical activity will be measured by self assessment scales, accelerometer and by number of performed Braining classes.

Data analysis: 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 Disorders
• Psychotic Disorders

• NCT number: NCT06012149
• Study type: Interventional
• Source: Region Stockholm
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Completion date: September 2026