Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: The Vega Trial

Study Overview
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Brief Summary
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This is a multicentre, pragmatic, randomised controlled trial to estimate the effect of a 4-month gym-based exercise training program on 1) patient-rated personal recovery (primary outcome), 2) Health-related quality of life, behavioral and functional symptoms, and cardiometabolic risk factors (secondary outcomes) in young adults with psychotic disorders. Four-hundred antipsychotic-treated young adults (between the age of 18 and 35), who are capable to undertake an exercise program (potentially with a friend or family member where possible) will be recruited from outpatient treatment units and mental health services. Participants will be randomised to treatment as usual or exercise at a 2:1 ratio in favor of exercise. Outcomes will be measured at baseline and at 4, 6 and 12 months after randomisation, by researchers masked to participant allocation.

Detailed Description
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Background: Antipsychotic medications are associated with development of metabolic side-effects. Patients with schizophrenia have a four-fold higher prevalence of metabolic syndrome, and a two-to-three-fold higher risk of cardiovascular diseases compared to the general population. These factors may contribute to the premature mortality of 15-20 years observed in people with schizophrenia. The increased morbidity and mortality in people with mental illness can be explained by several risk factors, including physical inactivity. Evidence suggests that exercise can have beneficial effects on multiple cardiometabolic outcomes, and improve clinical symptoms, quality of life, global functioning, and reduce negative and depressive symptoms in people with schizophrenia. In general, greater effects are seen for higher doses of aerobic exercise and motivational theory-based interventions supervised by exercise professionals. However, because of strict inclusion criteria, the external validity of existing studies is limited, and effectiveness studies are urgently needed Objectives: The primary objective is to determine the effectiveness of participation in a four-month supervised, gym-based exercise program among people treated with antipsychotic medication compared to usual care on patient-rated recovery (primary outcome). Secondary objectives are to examine if the gym-based exercise program compared to usual care improves the following: Mental health Health-related quality of life Behavioral and functional symptoms Metabolic health As tertiary objectives, we will investigate if: Prolongation of subsidized gym membership in addition to motivational text messages (extended support) will be superior to subsidized gym membership alone (minimal support), and to treatment as usual in relation to post-intervention adoption of physical activity. The exercise program impacts the quality of life and physical and mental health of the participants' primary relative. Participation in the gym-based program is associated with a reduction in the participants' use of mental health care services. The exercise program is cost-effective. Design: This is a multi-center, pragmatic, randomized (1:2) superiority trial to compare a 4-month, supervised, gym-based exercise training program to usual care. The pragmatic nature of the trial entails that it is designed to evaluate the effectiveness of interventions in real-life routine practice conditions. In order to explore different ways to support sustainment (i.e., post-intervention adherence/adoption of physical activity), and to guide strategies to facilitate adherence, we will do a study within a trial (SWAT). Hence participants randomized to the intervention at baseline, will be randomized (allocation ratio 1:1) after four months to minimal vs. extended support with regards to sustainment of physical activity.

Official Title
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Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: A Pragmatic, Single-blinded, Multicenter Randomized Controlled Trial

Conditions
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Affective Disorder, Psychosis

Intervention / Treatment
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* Behavioral: Supervised exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with a psychotic disorder (F20-F29 Schizophrenia, schizotypal and delusional disorders) or an affective disorder (F30-F39 Mood [affective] disorders) treated with antipsychotic medication (any dose) for at least one month able to read and speak Danish Exclusion Criteria: advised from participating in exercise training by their treating doctor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vega Exercise Community<br>Participants will be offered one hour of tailored supervised, gym-based exercise training three times per week for a period of four months. In addition, participants are offered free-of-charge membership to the gym for six months and are invited to take part in training classes and use fitness equipment provided by the gym to regular members. The supervised program is tailored to meet the needs and requirements of this particular group of young adults and will include three weekly sessions of moderate-to-high intensity and mobility exercises. | Behavioral: Supervised exercise<br>* The exercise sessions start with warm-up exercises, followed by 10-20 minutes resistance training (Part A), 10-20 minutes High Intensity Functional Training (HIFT) (Part B) and cool down. Instructors are allowed to make local adjustments as the delivery of the intervention is considered pragmatic. The participants can either perform the exercise together as one group, in pairs or one-by-one depending on individual needs and requests.<br>|
| No Intervention: Usual care<br>Participants will receive treatment as usual and be informed of the official physical activity guidelines as part of the information on group allocation. Moreover, they will be advised to continue their daily living, as they normally would do, not guiding them to other interventions neither preventing them to do so. In addition, participants in the usual care group will be given a subsidized membership including access to the exercise classes for four months after the 12 months follow up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal recovery | 15-item Questionnaire about the Process of Recovery | Baseline to four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal recovery | 15-item Questionnaire about the Process of Recovery | Baseline to six months and 12 months | 
| Mental health | Mental Component Summary from the Short-Form 12 (SF-12) Health survey | Baseline to four months | 
| Health-related quality of life | Short-Form 12 (SF-12) Health survey | Baseline to four, six and 12 months | 
| Affective symptoms | Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional distress | Baseline to four, six and 12 months | 
| Physical Activity | International Physical Activity Questionnaire short form (IPAQ-SF) | Baseline to four, six and 12 months | 
| Internalized Stigma | Internalized Stigma of Mental Illness Inventory (ISMI-9) short form | Baseline to four, six and 12 months | 
| Use of substance (alcohol, cannabis, drugs) | Measured by self-developed items with responses for each substance: never used, use less than once a month, regular use, harmful use | Baseline to four, six and 12 months | 
| Sleep | Brief Pittsburgh Sleep Quality Index (B-PSQI) | Baseline to four, six and 12 months | 
| Positive and negative symptoms | Colorado Symptom Index (MCSI) | Baseline to four, six and 12 months | 
| Loneliness | Measured by a single item on a Likert scale of 4 levels: During the past 12 months, have you felt lonely? | Baseline to four, six and 12 months | 
| Abdominal circumference | Measured with tape measure | Baseline to four, six and 12 months | 
| Body weight | Measured on a scale | Baseline to four, six and 12 months | 
| Skeletal muscle mass | Measured by bioimpedance | Baseline to four, six and 12 months | 
| Total body fat | Measured by bioimpedance | Baseline to four, six and 12 months | 
| Cardiorespiratory fitness | measured with the modified Ekblom-Bak submaximal cycle ergometer test | Baseline to four, six and 12 months | 
| Blood pressure | measured by a digital blood pressure monitor | Baseline to four, six and 12 months | 
| Resting heart rate | measured by a heart rate monitor | Baseline to four, six and 12 months | 
| High density lipoproteins (HDL) | Taken from routine blood tests (mmol/l) | Baseline to four, six and 12 months | 
| Low density lipoproteins (LDL) | Taken from routine blood tests (mmol/l) | Baseline to four, six and 12 months | 
| Triglycerides | Taken from routine blood tests (mmol/l) | Baseline to four, six and 12 months | 
| Glycosylated haemoglobin (HbA1c) | Taken from routine blood tests (mmol/l) | Baseline to four, six and 12 months | 
| C-reactive protein (CRP) | Taken from routine blood tests (mg/L) | Baseline to four, six and 12 months |