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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
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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.
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:
As tertiary objectives, we will investigate if:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vega Exercise Community | Experimental | 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. |
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| Usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Personal recovery | 15-item Questionnaire about the Process of Recovery | Baseline to four months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Use of the subsidized membership | To explore if prolongation of subsidized gym membership in addition to motivational text messages (extended support) is superior to subsidized gym membership alone (minimal support), and to treatment as usual in relation to post-intervention adoption of physical activity measured by use of the subsidized membership (intervention group only) | four to six months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9220 | Denmark | |||
| Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37648977 | Derived | Rafn BS, Andersen MF, Sorensen V, Bjerre ED, Baandrup L, Vernal DL, Mors O, Knop FK, Wolf RT, Tolver A, Firth J, Nohr N, Skou ST, Ebdrup BH, Midtgaard J. Value of gym-based group exercise versus usual care for young adults receiving antipsychotic medication: study protocol for the multicenter randomized controlled Vega trial. BMC Psychiatry. 2023 Aug 30;23(1):634. doi: 10.1186/s12888-023-05086-z. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2025 | Apr 23, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| 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 |
| Extended vs. minimal support for physical activity | To explore if prolongation of subsidized gym membership in addition to motivational text messages (extended support) is superior to subsidized gym membership alone (minimal support), and to treatment as usual in relation to post-intervention adoption of physical activity measured by the IPAQ-SF (both groups). | four to six months |
| Quality of life of primary relatives to participants | To explore the impact of the Vega Exercise Community on the quality of life measured by SF-12 of the participants' primary relative | Baseline to four, six and 12 months |
| Sleep of primary relatives to participants | To explore the impact of the Vega Exercise Community on sleep (measured by B-PSQI) of the participants' primary relative | Baseline to four, six and 12 months |
| Mental health of primary relatives to participants | To explore the impact of the Vega Exercise Community on mental health (measured by PROMIS Emotional Distress-Depression - Short Form 4a) of the participants' primary relative | Baseline to four, six and 12 months |
| Physical activity of primary relatives to participants | To explore the impact of the Vega Exercise Community on physical activity (measured by IPAQ-SF) of the participants' primary relative | Baseline to four, six and 12 months |
| Utilization of mental health care services | To explore differences between groups of participants' long-term use of mental health care services, specifically number of inpatient and outpatient mental health contacts, including mental health emergency departments obtained from medical records | 24 months and 60 months |
| Cost of the Vega Exercise Community | To explore the intervention cost i.e., education of instructors and delivery of exercise classes | Baseline to four, six and 12 months |
| Cost-effectiveness of the Vega Exercise Community | To explore the cost-effectiveness by comparing the cost and health-related quality of life, which will be measured by the EuroQol-5 Domain (EQ-5D) | Baseline to four, six and 12 months |
| Aarhus |
| 8200 |
| Denmark |
| Mental Health Centre Copenhagen | Copenhagen | 2100 | Denmark |
| Mental Health Centre Glostrup | Glostrup Municipality | 2600 | Denmark |