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

Psychosis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Affective Disorder
• Mood Disorders
• Psychosis

• NCT number: NCT05461885
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Contact: Bolette Skjødt Rafn, PhD
• Phone: 22913873
• Email: bolette.skjoedt.rafn@regionh.dk
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Completion date: October 2025