Affective Disorder, Psychosis
Conditions
Brief summary
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
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: 1. Mental health 2. Health-related quality of life 3. Behavioral and functional symptoms 4. Metabolic health As tertiary objectives, we will investigate if: 1. 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. 2. The exercise program impacts the quality of life and physical and mental health of the participants' primary relative. 3. Participation in the gym-based program is associated with a reduction in the participants' use of mental health care services. 4. 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.
Interventions
BEHAVIORALSupervised exercise
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.
Sponsors
Rigshospitalet, Denmark
Aarhus University Hospital
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with a psychotic disorder (F20-F29 Schizophrenia, schizotypal and delusional disorders) or an affective disorder (F30-F39 Mood \[affective\] disorders) * able to read and speak Danish or English
Exclusion criteria
* advised from participating in exercise training by their treating doctor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Personal recovery | Baseline to four months | 15-item Questionnaire about the Process of Recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Personal recovery | Baseline to six months and 12 months | 15-item Questionnaire about the Process of Recovery |
| Mental health | Baseline to four months | Mental Component Summary from the Short-Form 12 (SF-12) Health survey |
| Health-related quality of life | Baseline to four, six and 12 months | Short-Form 12 (SF-12) Health survey |
| Affective symptoms | Baseline to four, six and 12 months | Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional distress |
| Physical Activity | Baseline to four, six and 12 months | International Physical Activity Questionnaire short form (IPAQ-SF) |
| Internalized Stigma | Baseline to four, six and 12 months | Internalized Stigma of Mental Illness Inventory (ISMI-9) short form |
| Use of substance (alcohol, cannabis, drugs) | Baseline to four, six and 12 months | Measured by self-developed items with responses for each substance: "never used", "use less than once a month", "regular use", "harmful use" |
| Sleep | Baseline to four, six and 12 months | Brief Pittsburgh Sleep Quality Index (B-PSQI) |
| Positive and negative symptoms | Baseline to four, six and 12 months | Colorado Symptom Index (MCSI) |
| Loneliness | Baseline to four, six and 12 months | Measured by a single item on a Likert scale of 4 levels: "During the past 12 months, have you felt lonely?" |
| Abdominal circumference | Baseline to four, six and 12 months | Measured with tape measure |
| Body weight | Baseline to four, six and 12 months | Measured on a scale |
| Skeletal muscle mass | Baseline to four, six and 12 months | Measured by bioimpedance |
| Total body fat | Baseline to four, six and 12 months | Measured by bioimpedance |
| Cardiorespiratory fitness | Baseline to four, six and 12 months | measured with the modified Ekblom-Bak submaximal cycle ergometer test |
| Blood pressure | Baseline to four, six and 12 months | measured by a digital blood pressure monitor |
| Resting heart rate | Baseline to four, six and 12 months | measured by a heart rate monitor |
| High density lipoproteins (HDL) | Baseline to four, six and 12 months | Taken from routine blood tests (mmol/l) |
| Low density lipoproteins (LDL) | Baseline to four, six and 12 months | Taken from routine blood tests (mmol/l) |
| Triglycerides | Baseline to four, six and 12 months | Taken from routine blood tests (mmol/l) |
| Glycosylated haemoglobin (HbA1c) | Baseline to four, six and 12 months | Taken from routine blood tests (mmol/l) |
| C-reactive protein (CRP) | Baseline to four, six and 12 months | Taken from routine blood tests (mg/L) |
Countries
Denmark
Outcome results
None listed