Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry

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

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.

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 plan Continuous data will be analyzed using mixed effects models. The interaction effect of group and time will be the central estimate of the effect of the intervention Braining.

The primary analyses will follow the intention-to-treat principle and include all randomized participants. Adjusted as well as unadjusted results from analyses will be reported. Analyses will be adjusted for prespecified covariates to improve precision. Covariates adjusted for in the primary and secondary analysis will be age, sex, and unit where participants were registered as patients.

Missing data will be handled with multiple imputation with chained equations (MICE) to minimize bias compared to listwise deletion or single imputation and reflect the uncertainty caused by missingness. For each outcome, 20 datasets will be imputed and analyzed, pooling the results.

Per protocol analyses will be conducted as sensitivity analyses, including participants with at least 75% adherence to the intervention, defined as completion of ≥3 of 4 scheduled intervention visits. In the Braining arm, additional adherence will be defined as completion of at least eight Braining sessions. This approach is intended to estimate the effect of the intervention under conditions of adequate adherence.

Sensitivity analyses will examine the impact of alternative ActivPAL data validity criteria by restricting the sample to participants with 4-7 valid days of ActivPAL data. This analysis is intended to evaluate the robustness of the results to different assumptions regarding accelerometer data completeness.

Subgroup analysis:

• Will explore whether continuous variables of baseline depression severity, according to PHQ-9, moderate treatment effects in PHQ-9 and ActivPAL/MVPA.
• Will explore whether continuous variables of baseline physical activity levels, according to ActivPAL/MVPA, moderate treatment effects in primary analysis in ActivPAL/MVPA and PHQ-9.
• Will be conducted among participants with metabolic syndrome, defined as the presence of three or more cardiometabolic risk factors.

These analyses are considered secondary/exploratory and will be interpreted cautiously.

Inclusion Criteria:

• Patient at one of the psychiatric units

Exclusion Criteria:

• Physically active with moderate to vigorous physical activity above recommendations from World Health Organization (WHO) during the last 4 weeks
• Severe mental disorder such as ongoing mania, psychosis, and conditions when high risk of suicide or high risk of violence available according to the assessment of psychiatric staff at the unit.
• Medical conditions such as heart or lung disease, infection, withdrawal, where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
• Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions.
• Mental disability which means that you can not participate in group training.
• Difficulty speaking or understanding the Swedish language.
• Ongoing heavy substance use.