Clinical trial NCT05461885: Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: The Vega Trial
Official title: Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: A Pragmatic, Single-blinded, Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Affective Disorder
Psychosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Aalborg University Hospital
First posted: 2022-07-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Personal recovery
timeFrame: Baseline to four months
Secondary outcomes:
measure: Personal recovery
timeFrame: Baseline to six months and 12 months
measure: Mental health
timeFrame: Baseline to four months
measure: Health-related quality of life
timeFrame: Baseline to four, six and 12 months
measure: Affective symptoms
timeFrame: Baseline to four, six and 12 months
measure: Physical Activity
timeFrame: Baseline to four, six and 12 months
measure: Internalized Stigma
timeFrame: Baseline to four, six and 12 months
measure: Use of substance (alcohol, cannabis, drugs)
timeFrame: Baseline to four, six and 12 months
measure: Sleep
timeFrame: Baseline to four, six and 12 months
measure: Positive and negative symptoms
timeFrame: Baseline to four, six and 12 months
measure: Loneliness
timeFrame: Baseline to four, six and 12 months
measure: Abdominal circumference
timeFrame: Baseline to four, six and 12 months
measure: Body weight
timeFrame: Baseline to four, six and 12 months
measure: Skeletal muscle mass
timeFrame: Baseline to four, six and 12 months
measure: Total body fat
timeFrame: Baseline to four, six and 12 months
measure: Cardiorespiratory fitness
timeFrame: Baseline to four, six and 12 months
measure: Blood pressure
timeFrame: Baseline to four, six and 12 months
measure: Resting heart rate
timeFrame: Baseline to four, six and 12 months
measure: High density lipoproteins (HDL)
timeFrame: Baseline to four, six and 12 months
measure: Low density lipoproteins (LDL)
timeFrame: Baseline to four, six and 12 months
measure: Triglycerides
timeFrame: Baseline to four, six and 12 months
measure: Glycosylated haemoglobin (HbA1c)
timeFrame: Baseline to four, six and 12 months
measure: C-reactive protein (CRP)
timeFrame: Baseline to four, six and 12 months
Other outcomes:
measure: Use of the subsidized membership
timeFrame: four to six months
measure: Extended vs. minimal support for physical activity
timeFrame: four to six months
measure: Quality of life of primary relatives to participants
timeFrame: Baseline to four, six and 12 months
measure: Sleep of primary relatives to participants
timeFrame: Baseline to four, six and 12 months
measure: Mental health of primary relatives to participants
timeFrame: Baseline to four, six and 12 months
measure: Physical activity of primary relatives to participants
timeFrame: Baseline to four, six and 12 months
measure: Utilization of mental health care services
timeFrame: 24 months and 60 months
measure: Cost of the Vega Exercise Community
timeFrame: Baseline to four, six and 12 months
measure: Cost-effectiveness of the Vega Exercise Community
timeFrame: Baseline to four, six and 12 months
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Mental Health Centre Copenhagen
city: Glostrup
country: Denmark
facility: Mental Health Centre Glostrup
Study officials:
References: